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VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
ffieritas STANDARD TEST PROCEDURE
Product Name:
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Document No.:
TP/ BD 001/00
Effective
Version No,: 00
Superseded doc, No.: Nil
Review
Label
Claim
:
Date'. 12Feb2014
Date
'.
11 Feb 2017
Asmatab 10 Tablet (Each tablet contains Montelukast'10 mg as Montelukast Sodium INN)
Ref,
Method
Shelf
Life
: INN
Storage Condition: Store in a dry & cool place (below 25"C), Protected from liqht.
: 36 months
Paekino
' Rliqter /Ahr-Ahr iY10'q\
Approval of Current Version of the Document Name
Job Title
Prepared by
Md. Monjur Rahman
Checked by
Md. Tarikul lslam Bossunia
Asst. Manager Quality Control
Approved by
Md. Moniruzzaman
Quality Assurance Manager
Executive Quality Control
Signature & Date
,*%2,o ryr,,a6fs /aZ /ly
This document is Effective from the Date of the Approval.
WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED
IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK Page 1 of 13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
It/uradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Product Name: Doc. No,: TP/ BD 001/00
Version: 00
Prepared
By,
Yffi[,o
Approved By:
A,METHOD OF ANALYSIS OF GRANULES
A.1 Description Procedure:
Take about 1 gm of sample in
a watch glass and observe for its physical appearance, color, etc. using a white
background.
Limit: A white to Off-white colored, granules
A.2 ldentification
ln HPLC assay, the chromatogram obtained from the sample solution, shows a principal peak with the same retention time as the principal peak in the chromatogram obtained with the standard solution. b,
The UV absorption spectrum of the solution for assay preparation gives maxima at 220 nmt2nm, which corresponds to that of the Montelukast Sodium WS.
A.3 Moisture Content
Dry a weighing crucible !n an oven at 105'C for 30 minutes. Place it in desiccators, allow cooling and weighing
it.
Accurately weigh about 1.0 g of sample in the bottle and dry the stopper bottle in an oven at'100-105"C forone hour. Remove the crucible from oven and allow cooling in desiccators and reweigh. Calculate the percentage of loss on drying using the following formula:
Calculation:
M1-W2)x100 (w1-c)
= Where,
% loss
C = Weight of the crucible in g W1 = Weight of the crucible and sample before drying in g. W2 = Weight of the crucible and the sample after drying in g.
Limit: Not More Than 3.5 %
IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page 2 of 13
VERITAS PHARMACEUTICALS LIMITED,
ffiritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Product Name: Doc. No.: TP/ BD 001/00
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN) Version: 00
Prepared
By,
W_ltq
Approved
ay:=fu[ity
A.4 Assay
Method-|, (Bv HPLC)
Chromatoqraphic Svstem: Apparatus
Perkin Elmer Flexure HPLC with PDA Detector
Column
Cre, 150mmx4.6mm, 5p or equivalent
Mobile Phase
Weigh accurately 1.99 of ammonium acetate, transfer into 500m1 of beaker, add 500m1 of water and dissolve properly. Adjust the pH 3.5t0.05 with Glacial Acetic acid : Methanol(15:85)
Diluting solution
Water: Methanol (30 : 70 )
Temperature
Ambient (30'C)
Flow rate
1.5 ml/min
Monitoring wavelength
254nm
Load
10 pl
Retention Time
4-6
Standard preparation: Weigh and transfer accurately about 10.0 mg of working standard of Montelukast Sodium into a clean dry 100m1 standard volumetric flask. Add about 60ml diluting solution, Shake well and Sonicate for 5 minutes. Make volume with same diluting solution and mix well. Call this solution A. Filter it through 0.45 micron PTFE- membrane disk filter. Sample preparation: Weigh and powder 20 tablets. Transfer powdered sample equivalent to 10.0 mg of Montelukast into a clean 100m1 standard volumetric flask. Add 60ml diluting solution. Shake mechanically and sonicate for 5 minutes. Make volume with the same diluting solution and mix well. Call this solution B, Filter it through 0.45 micron PTFE- membrane disk filter.
Svstem suitabilitv test: Parameter lnjection six replicate of standard solution RSD
:
Acceptance criteria Not more than 2.0%
Place vials containing diluting solution as blank, standard preparation A and sample preparation B into the tray of the auto sampler of Perkin Elmer Flexure HPLC . Run the instrument and record the chromatogram, Calculate the quantity of Montelukast Sodium in sample using the following equation:
IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page 3
of
13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Product Name:
Version: 00
Doc. No.: TP/ BD 001/00
Prepared
rt,
YW,,
Approved
By:
ffit,
Calculation: Montelukast content, mg/tablet Peak area of sample X Wt. of standard (mg) X Y X Theoretical Avg. wt. of tablet
Peak area of standard X Wt. of sample (mg)
x
1.037X 100
Where, Y = Strength of Montelukast Sodium (Working standard) on as it is basis '1.037is the conversion factor from Montelukast Sodium to Montelukast
Hence calculate the amount in % of labeled amount by following formula:
Content (mg/tab)
-----..--- x
Assay, %=
100
Label claim (mg/tab)
Limit:
9.0
mg- 11.0
mg (90.0
%-
110.0 % ofthe label claim)
Method-ll:
By UV-Vis spectrophotometer
Preparation of Standard: Weigh and transfer accurately about 10.0 mg of working standard of Montelukast Sodium into a clean & dry 100 ml volumetric flask. Dissolved and Volume up to the mark with 0.5% SLS (Sodium Lauryl sulfate) solution, sonicate for 05 minutes and shake to mix well. Call the solution A. Transfer 5 ml of this solution A into a clean & dry 50 ml standard volumetric flask and volume up to the mark with same solvent and shake to mix well. Call the solution B.
Preparation of Sample: Weigh and powder 20 tablets. Transfer powder equivalent to 10.0 mg of Montelukast into a 100 ml standard flask. Volume up to the mark with 0.5% SLS (Sodium Lauryl sulfate) solution, sonicate for 05 minutes and shake to mix well. Filter this through WHATMAN filter paper. Call the filtrate solution C. Transfer 5 ml of this solution C into a clean & dry 50 ml standard volumetric flask and volume up to the mark with same solvent and shake to mix well. Call the solution D. Measure the absorption of solution B & D in a 1cm cell at the wavelength of maximum absorbance at about 280 nm with suitable Spectrophotometer using 0.5% SLS solution as a blank
IF THE DOCUMENT IS SIGNED BY BLUE INK, TT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 4 of 13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Product Name: Doc. No.:TP/ BD 001/00
Version: 00
prepared
By:
W,o
Approved av'
ffi{.
r"
Calculation: Montelukast content, mg/tablet Absorbance of sample X Wt. of standard (mg) X Y X Theoretical Avg. wt. of tablet
Absorbance of standard X Wt. of sample (mg) x 1 .037X 100
Where, Y = Strength of Montelukast Sodium (Working standard) on as it is basis 1.037 is the conversion factor from Montelukast Sodium to Montelukast Hence calculate the amount in % of labeled amount by following formula:
Content (mg/tab) Assay,
%=
---------- x 100 Labelclaim (mg/tab)
Limit:
9.0 mg
-
11.0 mg (90.0
%-
110.0 % ofthe label claim)
B,METHOD OF ANALYSIS CORETABLET B.l Description
Procedure: Take about core tablets. in a watch glass and observe for its physical appearance, color, etc. using a white background.
Limit: A white to off-white colored, round shaped tablet with "V" engraved on one side and break line on other side.
B.2 ldentification
Follow the Method Step A 2
8.3 Thickness Measure the Thickness of tablets with slide calipers and confirm the result.
Limit: 2.90 mm
-
3.25 mm (3.10 mm
t 5%)
IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 5
of
13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mo as Montelukast Sodium INN)
Product Name:
Version: 00
Doc. No.: TP/ BD 001/00
Prepared
By:
$4.,q.., l^/Ae-.1 t /.
Approved ev,
fr1ftv
8.4 Average Tablet Weight
Weigh 20 Tablets, selected at random, singly and calculate the average weight.
Total weight of 20 Tablets ( mg) Avg. Weight = 20
Limit: 90.0 mg
-
100.0 mg (95.0 mg
t 5%)
8.5 Uniformity of Weight
Determine the weight of each tablet and calculate the percentage variation from the average weight"
Let,
Average Weight of 20 Tablets = X Minimum weight of the
Tablet = X1
Maximum Weight of the Tablet = X2
Wherexl <x<x2 (X1-X)x100
Then, Then percentage variation from minimum weight =
X (X2-X)x100 And percentage variation from highest
weight
=
X
Limit: Out of 20 Tablets, maximum 2 tablets shall deviate t7.5o/o of average weight and none shall deviate
x
15% of
average weight.
8.6 Friability Loss
.
Dedust the tablets. Take Weight of 20 tablets selected at random. Place the tablets in the friability tester. Run the machine as per SOP VPL-QC-004-00 Let,
Weight of 20 Tablets before rotation= W1 g
IF THE DOCUMENT IS SIGNED BY BLUE
IN& IT IS A MASTER
DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 6 of 13
VERITAS PHARMACEUTICALS LIMITED,
Seritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montetukast 10 mg as Montelukast Sodium INN)
Product Name: Doc. No.: TP/ BD 001/00
Version: 00
Prepared
rt,
Yffij,.
Approvedey:
ffirv
Weight of 20 Tablets after rotation = W2 g
(W1-W2)x 100 So, Friability loss = W,1
Limit: Not more than 1%
B.7 Hardness Place the tablet between the jaws. For each measurement, orient the tablet in the same way with respect to the direction of application of the force. Carry out the measurement on 10 tablets and confirm the result against the specification. Determine the hardness of 10 core tablets in Kp using Suitable Hardness Tester, conversion factor of unit (Kg) to Kp.
1KP=9.76n Limit: Not less than 3.5
Kp
B,8 Moisture Content Collect approximately 5 g of sample. Crush the sample with mortar and pastel. Follow the HllJtnoO Step A.3
Limit: Not more than 3.5% 8.9 Disintegration Time Determine the disintegration time of six tablets. Place 700 mlwaterin the vessels, raise the temperature upto 37't1"C. lntroduce one tablet in each tube, add a disc, to each tube, follow SOP VPL-QC-002-00. Record the time to disintegrate all the six tablets.
Limit: Not more than 15 minutes 8.10 Assay Take the Assay % from the result of granules and calculate the content from the following formula:
Assay% from Granules x average weight of 20 tablets Assay % = ------Theoretical average weig ht
IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 7
of
13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mg as Monterukast sodium rNN)
Product Name: Doc. No.: TP/ BD 001/00
Version: 00
Prepared
By:
*|ffilr,
Approved ev'
.kfftv
Hence calculate the amount in mg/tablet of labeled amount by following formula:
Assay, % Content (mg/tab) =
- x Label claim (mg/tab) 100
Limit:
9.0 mg
-
11.0 mg (90.0
%-
110.0 % ofthe tabet ctaim)
C,METHOD OF ANALYSIS OF COATED TABLET C.1 Description
Procedure: Take about coated tablets in a watch glass and observe for its physical appearance, color, etc. using a white background.
Limit:A white to Off white colored, round shaped film coated tablet with "V" engraved on one side and otherside break line
C.2 Identification Follow the Method Step A.2 C.3 Thickness Measure the Thickness of tablets with slide calipers and confirm the result against the Specification.
Limit: 3.0 mm - 3.33 mm (3.17 mm
t 5%)
C.4 Average Tablet Weight Follow the Method Step B.4
Limit: 92.0 mg
-
102.0 mg (97.0 mg
t
5 %)
C.5 Uniformity of Weight Follow the Method Step B.5
Limit: Out of 20 Tablets, maximum 2 Tablets shall deviate
t
7.5 of average weight and none shall deviate r1S
o/o
average weight
of
C.6 Hardness Follow the Method Step B.7
Limit: Not less than 4 Kp IF THE DOCUMENT IS SIGNED BY BLUE
INI( IT IS A MASTER
DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page B
of
13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
Seritas STANDARD TEST PROCEDURE
Product Name:
(Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Prepared
Version:00
Doc. No.: TP/ BD 001/00
By:
\'ff;i,
Approved Bv:
ftffirv
C.7 Moisture Content Step A. 3 Collect approximately 5 g of sample. Crush the sample with mortar and pastel. Follow the Method
Limit: Not more than 3.5%
C.8 Disintegration Time Follow the Method SteP B.9
Limit: Not more than 30 minutes
C.9 Dissolution Method-1,(By HPLC)
Chromatoqraphic Svstem: Apparatus
Perkin Elmer Flexure HPLC with PDA Detector
Column
Cra, 150mmx4.6mm, 5;r or equivalent
Weigh accurately 1.9 g of ammonium acetatelransfer into 500m1 of beaker, add 500m1 of water and dissolve properly. Adjust the pH 3.5t0.05 with GlacialAcetic acid : Methanol(15:85)
Mobile Phase
Diluting solution
0.025M Tri-sodium o(hophosPhate
Temperature
Ambient (30'C)
Flow rate
1.5 ml/min
Monitoring wavelength
254nm
Load
10 pl
Retention Time
4-6
Dissolution Svstem: Dissolution medium
: 0.025M Tri-sodium orthophosphate, 1000m1
Apparatus
: 2 (Paddle)
Stirring speed
: 100 rpm
Temperature
:37t0.5"C
Time
:45
min
rF THE DOCUMENT rS STGNED By BLUE
rN& rT IS
A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE
WOR(
Page 9
of
-
13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
ffieritas STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Product Name:
Version: 00
Doc. No.:TP/ BD 001/00
Prepared
By:
Y{Xil,
Approved By:
Standard preparation: Weigh and transfer accurately about 10.0 mg of working standard of Montelukast Sodium into a clean dry 100m1 standard 5 minutes, Make volume with same volumetric flask, Add about 60ml diluting solution. Shake well and Sonicate
for
diluting solution and mix well. Call this solution
A.
Filter it through 0.45 micron PTFE- membrane disk filter.
Callthis solution A. Transfer 10 mlof this solution to l00mlvolumetric flask & dilute with dissolution medium to volume. Filter this solution through 0.2p disk filter. Call this solution B.
Sample preparation: Place 1000 ml of dissolution media into each vessel, and assemble the apparatus. Allow the medium to equilibrate to a temperature of 37t0.5"C. Place 1 tablet into each bucket, cover it and operate the apparatus at the specified rate. After 45min withdraw a definite volume of sample and filter it with filter paper. Again filter the filtrate through 0.2p disk filter. Call this solution C.
Procedure: Place vials containing standard preparation B and sample preparation C into the tray of auto sampler of Perkin Elmer
Flexure HPLC. Run the instrument and record the chromatogram. Calculate the quantitles
of Montelukast present
in
sample preparation using the following equation.
Calculation: Percent release of Montelukast,
of sample C x Weight of standard (mg) x Y Peak area of standard B x 10 x1.037
Peak area
Where, Y = Potency of Montelukast Sodium. (Working standard, as it is) 1.037= Conversion Ratio of Montelukast Sodium to Montelukast.
lnterpretation : Unless otherwise specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolvbd from the units tested conform to the accompanying acceptance table. Continue testing through
the three stages unless the results conform at either 51 or 52 . The quantity, Q, is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labeled content; the 5%, 15% and 250/o values in the Acceptance Table are percentages of the labeled content so that these values and Q are in the same . Stage
Number Tested
Sr
:
Sz
6
S:
12
Acceptance criteria Each unit is not less than Q + 5%
Average of '12 units (Sr + Sz ) is equal to or greater than Q, and no unit is less than Q - 15o/o Average of 24 units (Sr + Sz + Se) is equal to or greater than Q, not more than 2 units are less than Q - 15%, and no unit is less than
Q-25o/o
Limit: Not less than 70% within 30 minutes. IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 10
of
13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
Seritas STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Product Name:
Version:00
Doc. No.: TP/ BD 001/00
prepared av,
tfff$1a
Approved By:
ftTil"2,"
Method-ll:
By UV-Vis spectrophotometer
Preparation of 0.025M Tri Sodium Orthophosphate:
Weight and dissolved 9.5 g TriSodium Orthophosphate in 1000 mlwater.
Dissolution Svstem: Dissolution
medium
:0.025MTri-sodiumorthophosphate,l000ml
Apparatus
: 2 (Paddle)
Stirring speed
: 100 rpm
Temperature
:37t0.5'C
Time
:45
min
Standard preparation: Weigh and transfer accurately about 10.4 mg of working standard of Montelukast Sodium into a clean dry 100m1 standard 5 minutes. Make volumetric flask. Add about 60ml 0.025M Tri Sodium Orthophosphate. Shake well and Sonicate to 100m1 volumetric solution A. Transfer 10 ml of this solution . mix well. Call this and solution volume with same diluting filter. Call this disk through 0.2p volume. Filter this solution to flask & dilute with 0.025M Tri Sodium Orthophosphate
for
solution B.
Sample preparation: Place 1000 ml of dissolution media into each vessel, and assemble the apparatus. Allow the medium to equililirate to a temperature of 37t0.5'C. Place 1 tablet into each bucket, cover it and operate the apparatus at the specified rate. After 45min withdraw a definite volume of sample and filter it with filter paper, Call this solution C. Take the absorbance of both B & C solution
al344t2 nm in a UV Vis spectrophotometer, using 0.025M Tri
Sodium
Orlhophosphate buffer as blank.
Galculation: Montelukast content, mg/tablet Absorbance of sample X Wt. of standard (mg) X Y
Absorbance of standard X 10 x
1=0T t" 6 )7
Where, Y = Potency of Montelukast Sodium. (Working standard, as it is) 1.037= Conversion Ratio of Montelukast Sodium to Montelukast
.
IF THE DOCUMENT IS SIGNED BY BLUE INr(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 11 of 13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
ffieritas STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Product Name: Doc. No.: TP/ BD 001/00
Version: 00
Prepared
By: )(ff^Lr,,
Approved
ay:ffi"tv
lnterpretation : Unless othenivise
specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolved from the units tested conform to the accompanying acceptance table. Continue testing through the three stages unless the results conform at either 51 or 52 . The quantity, Q, is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labeled content; the 5%, 15o/o and 25o/o values in the Acceptance Table are percentages of the labeled content so that these values and Q are in the same .
Stage
Number Tested
Acceptance criteria
Sr
6
Each unit is not less than Q + 5%
Sz
6
Se
12
Average of 12 units (Sr + Sz ) is equal to or greater than Q, and no unit is less than Q - 15% Average of 24 units (Sr + Sz + Sr) is equal to or greater than Q, not more than 2 units are less than Q - 150/0, and no unit is less than
Q-25% Limit: Not less than 70% within 30 minutes. C.10 Assay Crush coated tablets and follow Step No. A.4
Limit:
9.0 mg
-
11.0 mg (90.0 % - 110 0 % of the label claim)
C. 11 Content Uniformity
Follow Step 44 for chromatographic condition, standard preparation and system suitability.
Sample Preparation: Transfer one tablet into a clean 100m1 standard volumetric flask. Add 60ml diluting solution. Shake mechanically and sonicate for 5 minutes. Make volume with the same diluting solution and mix well. Call this solution Br. Filter it through 0.45 micron PTFE- membrane disk filter. Carry out the above procedure with other nine tablets. Call these solutions Bz, Bs , B+ ------Bro. Place vials containing diluting solution as blank, standard preparation A and sample preparation B* ( Br , Bz , --------Bro) into the tray of the auto sampler of Perkin Elmer Flexure HPLC. Run the instrument and record the chromatogram. Calculate the quantity of Montelukast Sodium in sample using the following equation:
IF THE DOCUMENT IS SIGNED BY BLUE
INK IT IS
A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 12
of
13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
Seritas STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Product Name:
Prepared
Version: 00
Doc. No,:TP/ BD 001/00
tr
YiE)l-'.
Approved By:
Siffi1
y
Calculation:
Montelukast content, % Peak area of sample X Wt. of standard (mg) X Y X 100
Peak area of standard X Wt. of sample (mg)
x
1
.037X 100
Where, Y = Strength of Montelukast Sodium (Working standard) on as it is basis 1.037is the conversion factor from Montelukast Sodium to Montelukast Hence calculate the amount in % of labeled amount by following formula: Content (mg/tab) Assay,
%=
------
x 100
Labelclaim (mg/tab)
Limit:
lndividual content is in 85.0 %
-
1
15^0 % of
the average content
D.Finished Produ ct
T
est Meth od
D.1 Take results of coated tablets for all the parameters of finished products.
D.2 Check the strips and inner cartoon of the finished product and the below information: a. Batch No. b. Mfg. Date
c. Exp. Date d. MRP e. No. of tablets /strip
f. No. of strips per inner ca(oon. Revision History Document No,
TPi BD 001/00
.
Version No
Date
00
Feb-2014
Reason lnitial Test procedure of Asmatab '10 Tablet
IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page 13 of 13
ffieritas STANDARD TEST PROCEDURE
Product Name:
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Document No.:
TP/ BD 001/00
Effective
Version No,: 00
Superseded doc, No.: Nil
Review
Label
Claim
:
Date'. 12Feb2014
Date
'.
11 Feb 2017
Asmatab 10 Tablet (Each tablet contains Montelukast'10 mg as Montelukast Sodium INN)
Ref,
Method
Shelf
Life
: INN
Storage Condition: Store in a dry & cool place (below 25"C), Protected from liqht.
: 36 months
Paekino
' Rliqter /Ahr-Ahr iY10'q\
Approval of Current Version of the Document Name
Job Title
Prepared by
Md. Monjur Rahman
Checked by
Md. Tarikul lslam Bossunia
Asst. Manager Quality Control
Approved by
Md. Moniruzzaman
Quality Assurance Manager
Executive Quality Control
Signature & Date
,*%2,o ryr,,a6fs /aZ /ly
This document is Effective from the Date of the Approval.
WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED
IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK Page 1 of 13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
It/uradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Product Name: Doc. No,: TP/ BD 001/00
Version: 00
Prepared
By,
Yffi[,o
Approved By:
A,METHOD OF ANALYSIS OF GRANULES
A.1 Description Procedure:
Take about 1 gm of sample in
a watch glass and observe for its physical appearance, color, etc. using a white
background.
Limit: A white to Off-white colored, granules
A.2 ldentification
ln HPLC assay, the chromatogram obtained from the sample solution, shows a principal peak with the same retention time as the principal peak in the chromatogram obtained with the standard solution. b,
The UV absorption spectrum of the solution for assay preparation gives maxima at 220 nmt2nm, which corresponds to that of the Montelukast Sodium WS.
A.3 Moisture Content
Dry a weighing crucible !n an oven at 105'C for 30 minutes. Place it in desiccators, allow cooling and weighing
it.
Accurately weigh about 1.0 g of sample in the bottle and dry the stopper bottle in an oven at'100-105"C forone hour. Remove the crucible from oven and allow cooling in desiccators and reweigh. Calculate the percentage of loss on drying using the following formula:
Calculation:
M1-W2)x100 (w1-c)
= Where,
% loss
C = Weight of the crucible in g W1 = Weight of the crucible and sample before drying in g. W2 = Weight of the crucible and the sample after drying in g.
Limit: Not More Than 3.5 %
IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page 2 of 13
VERITAS PHARMACEUTICALS LIMITED,
ffiritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Product Name: Doc. No.: TP/ BD 001/00
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN) Version: 00
Prepared
By,
W_ltq
Approved
ay:=fu[ity
A.4 Assay
Method-|, (Bv HPLC)
Chromatoqraphic Svstem: Apparatus
Perkin Elmer Flexure HPLC with PDA Detector
Column
Cre, 150mmx4.6mm, 5p or equivalent
Mobile Phase
Weigh accurately 1.99 of ammonium acetate, transfer into 500m1 of beaker, add 500m1 of water and dissolve properly. Adjust the pH 3.5t0.05 with Glacial Acetic acid : Methanol(15:85)
Diluting solution
Water: Methanol (30 : 70 )
Temperature
Ambient (30'C)
Flow rate
1.5 ml/min
Monitoring wavelength
254nm
Load
10 pl
Retention Time
4-6
Standard preparation: Weigh and transfer accurately about 10.0 mg of working standard of Montelukast Sodium into a clean dry 100m1 standard volumetric flask. Add about 60ml diluting solution, Shake well and Sonicate for 5 minutes. Make volume with same diluting solution and mix well. Call this solution A. Filter it through 0.45 micron PTFE- membrane disk filter. Sample preparation: Weigh and powder 20 tablets. Transfer powdered sample equivalent to 10.0 mg of Montelukast into a clean 100m1 standard volumetric flask. Add 60ml diluting solution. Shake mechanically and sonicate for 5 minutes. Make volume with the same diluting solution and mix well. Call this solution B, Filter it through 0.45 micron PTFE- membrane disk filter.
Svstem suitabilitv test: Parameter lnjection six replicate of standard solution RSD
:
Acceptance criteria Not more than 2.0%
Place vials containing diluting solution as blank, standard preparation A and sample preparation B into the tray of the auto sampler of Perkin Elmer Flexure HPLC . Run the instrument and record the chromatogram, Calculate the quantity of Montelukast Sodium in sample using the following equation:
IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page 3
of
13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Product Name:
Version: 00
Doc. No.: TP/ BD 001/00
Prepared
rt,
YW,,
Approved
By:
ffit,
Calculation: Montelukast content, mg/tablet Peak area of sample X Wt. of standard (mg) X Y X Theoretical Avg. wt. of tablet
Peak area of standard X Wt. of sample (mg)
x
1.037X 100
Where, Y = Strength of Montelukast Sodium (Working standard) on as it is basis '1.037is the conversion factor from Montelukast Sodium to Montelukast
Hence calculate the amount in % of labeled amount by following formula:
Content (mg/tab)
-----..--- x
Assay, %=
100
Label claim (mg/tab)
Limit:
9.0
mg- 11.0
mg (90.0
%-
110.0 % ofthe label claim)
Method-ll:
By UV-Vis spectrophotometer
Preparation of Standard: Weigh and transfer accurately about 10.0 mg of working standard of Montelukast Sodium into a clean & dry 100 ml volumetric flask. Dissolved and Volume up to the mark with 0.5% SLS (Sodium Lauryl sulfate) solution, sonicate for 05 minutes and shake to mix well. Call the solution A. Transfer 5 ml of this solution A into a clean & dry 50 ml standard volumetric flask and volume up to the mark with same solvent and shake to mix well. Call the solution B.
Preparation of Sample: Weigh and powder 20 tablets. Transfer powder equivalent to 10.0 mg of Montelukast into a 100 ml standard flask. Volume up to the mark with 0.5% SLS (Sodium Lauryl sulfate) solution, sonicate for 05 minutes and shake to mix well. Filter this through WHATMAN filter paper. Call the filtrate solution C. Transfer 5 ml of this solution C into a clean & dry 50 ml standard volumetric flask and volume up to the mark with same solvent and shake to mix well. Call the solution D. Measure the absorption of solution B & D in a 1cm cell at the wavelength of maximum absorbance at about 280 nm with suitable Spectrophotometer using 0.5% SLS solution as a blank
IF THE DOCUMENT IS SIGNED BY BLUE INK, TT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 4 of 13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Product Name: Doc. No.:TP/ BD 001/00
Version: 00
prepared
By:
W,o
Approved av'
ffi{.
r"
Calculation: Montelukast content, mg/tablet Absorbance of sample X Wt. of standard (mg) X Y X Theoretical Avg. wt. of tablet
Absorbance of standard X Wt. of sample (mg) x 1 .037X 100
Where, Y = Strength of Montelukast Sodium (Working standard) on as it is basis 1.037 is the conversion factor from Montelukast Sodium to Montelukast Hence calculate the amount in % of labeled amount by following formula:
Content (mg/tab) Assay,
%=
---------- x 100 Labelclaim (mg/tab)
Limit:
9.0 mg
-
11.0 mg (90.0
%-
110.0 % ofthe label claim)
B,METHOD OF ANALYSIS CORETABLET B.l Description
Procedure: Take about core tablets. in a watch glass and observe for its physical appearance, color, etc. using a white background.
Limit: A white to off-white colored, round shaped tablet with "V" engraved on one side and break line on other side.
B.2 ldentification
Follow the Method Step A 2
8.3 Thickness Measure the Thickness of tablets with slide calipers and confirm the result.
Limit: 2.90 mm
-
3.25 mm (3.10 mm
t 5%)
IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 5
of
13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mo as Montelukast Sodium INN)
Product Name:
Version: 00
Doc. No.: TP/ BD 001/00
Prepared
By:
$4.,q.., l^/Ae-.1 t /.
Approved ev,
fr1ftv
8.4 Average Tablet Weight
Weigh 20 Tablets, selected at random, singly and calculate the average weight.
Total weight of 20 Tablets ( mg) Avg. Weight = 20
Limit: 90.0 mg
-
100.0 mg (95.0 mg
t 5%)
8.5 Uniformity of Weight
Determine the weight of each tablet and calculate the percentage variation from the average weight"
Let,
Average Weight of 20 Tablets = X Minimum weight of the
Tablet = X1
Maximum Weight of the Tablet = X2
Wherexl <x<x2 (X1-X)x100
Then, Then percentage variation from minimum weight =
X (X2-X)x100 And percentage variation from highest
weight
=
X
Limit: Out of 20 Tablets, maximum 2 tablets shall deviate t7.5o/o of average weight and none shall deviate
x
15% of
average weight.
8.6 Friability Loss
.
Dedust the tablets. Take Weight of 20 tablets selected at random. Place the tablets in the friability tester. Run the machine as per SOP VPL-QC-004-00 Let,
Weight of 20 Tablets before rotation= W1 g
IF THE DOCUMENT IS SIGNED BY BLUE
IN& IT IS A MASTER
DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 6 of 13
VERITAS PHARMACEUTICALS LIMITED,
Seritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montetukast 10 mg as Montelukast Sodium INN)
Product Name: Doc. No.: TP/ BD 001/00
Version: 00
Prepared
rt,
Yffij,.
Approvedey:
ffirv
Weight of 20 Tablets after rotation = W2 g
(W1-W2)x 100 So, Friability loss = W,1
Limit: Not more than 1%
B.7 Hardness Place the tablet between the jaws. For each measurement, orient the tablet in the same way with respect to the direction of application of the force. Carry out the measurement on 10 tablets and confirm the result against the specification. Determine the hardness of 10 core tablets in Kp using Suitable Hardness Tester, conversion factor of unit (Kg) to Kp.
1KP=9.76n Limit: Not less than 3.5
Kp
B,8 Moisture Content Collect approximately 5 g of sample. Crush the sample with mortar and pastel. Follow the HllJtnoO Step A.3
Limit: Not more than 3.5% 8.9 Disintegration Time Determine the disintegration time of six tablets. Place 700 mlwaterin the vessels, raise the temperature upto 37't1"C. lntroduce one tablet in each tube, add a disc, to each tube, follow SOP VPL-QC-002-00. Record the time to disintegrate all the six tablets.
Limit: Not more than 15 minutes 8.10 Assay Take the Assay % from the result of granules and calculate the content from the following formula:
Assay% from Granules x average weight of 20 tablets Assay % = ------Theoretical average weig ht
IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 7
of
13
VERITAS PHARMACEUTICALS LIMITED,
ffieritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mg as Monterukast sodium rNN)
Product Name: Doc. No.: TP/ BD 001/00
Version: 00
Prepared
By:
*|ffilr,
Approved ev'
.kfftv
Hence calculate the amount in mg/tablet of labeled amount by following formula:
Assay, % Content (mg/tab) =
- x Label claim (mg/tab) 100
Limit:
9.0 mg
-
11.0 mg (90.0
%-
110.0 % ofthe tabet ctaim)
C,METHOD OF ANALYSIS OF COATED TABLET C.1 Description
Procedure: Take about coated tablets in a watch glass and observe for its physical appearance, color, etc. using a white background.
Limit:A white to Off white colored, round shaped film coated tablet with "V" engraved on one side and otherside break line
C.2 Identification Follow the Method Step A.2 C.3 Thickness Measure the Thickness of tablets with slide calipers and confirm the result against the Specification.
Limit: 3.0 mm - 3.33 mm (3.17 mm
t 5%)
C.4 Average Tablet Weight Follow the Method Step B.4
Limit: 92.0 mg
-
102.0 mg (97.0 mg
t
5 %)
C.5 Uniformity of Weight Follow the Method Step B.5
Limit: Out of 20 Tablets, maximum 2 Tablets shall deviate
t
7.5 of average weight and none shall deviate r1S
o/o
average weight
of
C.6 Hardness Follow the Method Step B.7
Limit: Not less than 4 Kp IF THE DOCUMENT IS SIGNED BY BLUE
INI( IT IS A MASTER
DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page B
of
13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
Seritas STANDARD TEST PROCEDURE
Product Name:
(Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Prepared
Version:00
Doc. No.: TP/ BD 001/00
By:
\'ff;i,
Approved Bv:
ftffirv
C.7 Moisture Content Step A. 3 Collect approximately 5 g of sample. Crush the sample with mortar and pastel. Follow the Method
Limit: Not more than 3.5%
C.8 Disintegration Time Follow the Method SteP B.9
Limit: Not more than 30 minutes
C.9 Dissolution Method-1,(By HPLC)
Chromatoqraphic Svstem: Apparatus
Perkin Elmer Flexure HPLC with PDA Detector
Column
Cra, 150mmx4.6mm, 5;r or equivalent
Weigh accurately 1.9 g of ammonium acetatelransfer into 500m1 of beaker, add 500m1 of water and dissolve properly. Adjust the pH 3.5t0.05 with GlacialAcetic acid : Methanol(15:85)
Mobile Phase
Diluting solution
0.025M Tri-sodium o(hophosPhate
Temperature
Ambient (30'C)
Flow rate
1.5 ml/min
Monitoring wavelength
254nm
Load
10 pl
Retention Time
4-6
Dissolution Svstem: Dissolution medium
: 0.025M Tri-sodium orthophosphate, 1000m1
Apparatus
: 2 (Paddle)
Stirring speed
: 100 rpm
Temperature
:37t0.5"C
Time
:45
min
rF THE DOCUMENT rS STGNED By BLUE
rN& rT IS
A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE
WOR(
Page 9
of
-
13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
ffieritas STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Product Name:
Version: 00
Doc. No.:TP/ BD 001/00
Prepared
By:
Y{Xil,
Approved By:
Standard preparation: Weigh and transfer accurately about 10.0 mg of working standard of Montelukast Sodium into a clean dry 100m1 standard 5 minutes, Make volume with same volumetric flask, Add about 60ml diluting solution. Shake well and Sonicate
for
diluting solution and mix well. Call this solution
A.
Filter it through 0.45 micron PTFE- membrane disk filter.
Callthis solution A. Transfer 10 mlof this solution to l00mlvolumetric flask & dilute with dissolution medium to volume. Filter this solution through 0.2p disk filter. Call this solution B.
Sample preparation: Place 1000 ml of dissolution media into each vessel, and assemble the apparatus. Allow the medium to equilibrate to a temperature of 37t0.5"C. Place 1 tablet into each bucket, cover it and operate the apparatus at the specified rate. After 45min withdraw a definite volume of sample and filter it with filter paper. Again filter the filtrate through 0.2p disk filter. Call this solution C.
Procedure: Place vials containing standard preparation B and sample preparation C into the tray of auto sampler of Perkin Elmer
Flexure HPLC. Run the instrument and record the chromatogram. Calculate the quantitles
of Montelukast present
in
sample preparation using the following equation.
Calculation: Percent release of Montelukast,
of sample C x Weight of standard (mg) x Y Peak area of standard B x 10 x1.037
Peak area
Where, Y = Potency of Montelukast Sodium. (Working standard, as it is) 1.037= Conversion Ratio of Montelukast Sodium to Montelukast.
lnterpretation : Unless otherwise specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolvbd from the units tested conform to the accompanying acceptance table. Continue testing through
the three stages unless the results conform at either 51 or 52 . The quantity, Q, is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labeled content; the 5%, 15% and 250/o values in the Acceptance Table are percentages of the labeled content so that these values and Q are in the same . Stage
Number Tested
Sr
:
Sz
6
S:
12
Acceptance criteria Each unit is not less than Q + 5%
Average of '12 units (Sr + Sz ) is equal to or greater than Q, and no unit is less than Q - 15o/o Average of 24 units (Sr + Sz + Se) is equal to or greater than Q, not more than 2 units are less than Q - 15%, and no unit is less than
Q-25o/o
Limit: Not less than 70% within 30 minutes. IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 10
of
13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
Seritas STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Product Name:
Version:00
Doc. No.: TP/ BD 001/00
prepared av,
tfff$1a
Approved By:
ftTil"2,"
Method-ll:
By UV-Vis spectrophotometer
Preparation of 0.025M Tri Sodium Orthophosphate:
Weight and dissolved 9.5 g TriSodium Orthophosphate in 1000 mlwater.
Dissolution Svstem: Dissolution
medium
:0.025MTri-sodiumorthophosphate,l000ml
Apparatus
: 2 (Paddle)
Stirring speed
: 100 rpm
Temperature
:37t0.5'C
Time
:45
min
Standard preparation: Weigh and transfer accurately about 10.4 mg of working standard of Montelukast Sodium into a clean dry 100m1 standard 5 minutes. Make volumetric flask. Add about 60ml 0.025M Tri Sodium Orthophosphate. Shake well and Sonicate to 100m1 volumetric solution A. Transfer 10 ml of this solution . mix well. Call this and solution volume with same diluting filter. Call this disk through 0.2p volume. Filter this solution to flask & dilute with 0.025M Tri Sodium Orthophosphate
for
solution B.
Sample preparation: Place 1000 ml of dissolution media into each vessel, and assemble the apparatus. Allow the medium to equililirate to a temperature of 37t0.5'C. Place 1 tablet into each bucket, cover it and operate the apparatus at the specified rate. After 45min withdraw a definite volume of sample and filter it with filter paper, Call this solution C. Take the absorbance of both B & C solution
al344t2 nm in a UV Vis spectrophotometer, using 0.025M Tri
Sodium
Orlhophosphate buffer as blank.
Galculation: Montelukast content, mg/tablet Absorbance of sample X Wt. of standard (mg) X Y
Absorbance of standard X 10 x
1=0T t" 6 )7
Where, Y = Potency of Montelukast Sodium. (Working standard, as it is) 1.037= Conversion Ratio of Montelukast Sodium to Montelukast
.
IF THE DOCUMENT IS SIGNED BY BLUE INr(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 11 of 13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
ffieritas STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Product Name: Doc. No.: TP/ BD 001/00
Version: 00
Prepared
By: )(ff^Lr,,
Approved
ay:ffi"tv
lnterpretation : Unless othenivise
specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolved from the units tested conform to the accompanying acceptance table. Continue testing through the three stages unless the results conform at either 51 or 52 . The quantity, Q, is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labeled content; the 5%, 15o/o and 25o/o values in the Acceptance Table are percentages of the labeled content so that these values and Q are in the same .
Stage
Number Tested
Acceptance criteria
Sr
6
Each unit is not less than Q + 5%
Sz
6
Se
12
Average of 12 units (Sr + Sz ) is equal to or greater than Q, and no unit is less than Q - 15% Average of 24 units (Sr + Sz + Sr) is equal to or greater than Q, not more than 2 units are less than Q - 150/0, and no unit is less than
Q-25% Limit: Not less than 70% within 30 minutes. C.10 Assay Crush coated tablets and follow Step No. A.4
Limit:
9.0 mg
-
11.0 mg (90.0 % - 110 0 % of the label claim)
C. 11 Content Uniformity
Follow Step 44 for chromatographic condition, standard preparation and system suitability.
Sample Preparation: Transfer one tablet into a clean 100m1 standard volumetric flask. Add 60ml diluting solution. Shake mechanically and sonicate for 5 minutes. Make volume with the same diluting solution and mix well. Call this solution Br. Filter it through 0.45 micron PTFE- membrane disk filter. Carry out the above procedure with other nine tablets. Call these solutions Bz, Bs , B+ ------Bro. Place vials containing diluting solution as blank, standard preparation A and sample preparation B* ( Br , Bz , --------Bro) into the tray of the auto sampler of Perkin Elmer Flexure HPLC. Run the instrument and record the chromatogram. Calculate the quantity of Montelukast Sodium in sample using the following equation:
IF THE DOCUMENT IS SIGNED BY BLUE
INK IT IS
A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 12
of
13
VERITAS PHARMACEUTICALS LIMITED, Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
Seritas STANDARD TEST PROCEDURE
Asmatab 10 Tablet (Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Product Name:
Prepared
Version: 00
Doc. No,:TP/ BD 001/00
tr
YiE)l-'.
Approved By:
Siffi1
y
Calculation:
Montelukast content, % Peak area of sample X Wt. of standard (mg) X Y X 100
Peak area of standard X Wt. of sample (mg)
x
1
.037X 100
Where, Y = Strength of Montelukast Sodium (Working standard) on as it is basis 1.037is the conversion factor from Montelukast Sodium to Montelukast Hence calculate the amount in % of labeled amount by following formula: Content (mg/tab) Assay,
%=
------
x 100
Labelclaim (mg/tab)
Limit:
lndividual content is in 85.0 %
-
1
15^0 % of
the average content
D.Finished Produ ct
T
est Meth od
D.1 Take results of coated tablets for all the parameters of finished products.
D.2 Check the strips and inner cartoon of the finished product and the below information: a. Batch No. b. Mfg. Date
c. Exp. Date d. MRP e. No. of tablets /strip
f. No. of strips per inner ca(oon. Revision History Document No,
TPi BD 001/00
.
Version No
Date
00
Feb-2014
Reason lnitial Test procedure of Asmatab '10 Tablet
IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page 13 of 13
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