Bimatoprost MVP

Protocol No.: CMP/CSP/24/0038/1.
TITLE: Analytical Method Verification Protocol for the determination of water content in
Bimatoprost by Coulometri Titration.
Product Name Bimatoprost

Type of Study Method Verification
Vimta Regn No./Study ID VLL/VLS/24/00455/001
STP and Specification No.: 022200, Revision No.: 000
Reference Document No.
As per USP <921>
Batch Number/Lot Number E030 235BA01

Customer Name SamChunDang Pharm Co., Ltd
Vimta Approvals
Function Name Designation & Department Signature & Date
Preparation
Review
Review
Approval
Approval
SamChunDang Pharm Co., Ltd Approvals
Function Name Designation & Department Signature & Date
Review
Approval
Vimta Labs Ltd, Life Sciences Campus, Plot No. 5, MN Park, Genome Valley,
Shameerpet, Medchal-Malkajgiri-500101, Hyderabad, Telangana, India
Page 1 of 5
Protocol No.: CMP/CSP/24/0038/1.0
Contents
1.0 Objective .............................................................................................................................. 3

2.0 Scope .................................................................................................................................... 3
3.0 Details of Instruments / Equipments, Reagents, Sample and Standard .............................. 3
4.0 Method of Analysis .............................................................................................................. 3
5.0 Verification Plan .................................................................................................................. 4
6.0 Analytical Method Verification ........................................................................................... 4
6.1 Method Precision .................................................................................................................. 4
7.0 References ............................................................................................................................ 5

8.0 Incidents, Ammendments and Deviations ........................................................................... 5
9.0 Terms and Abbreviations ..................................................................................................... 5
Page 2 of 5
1.0 Objective
The objective of this protocol is to verify the method for the determination of water content
in Bimatoprost by Coulometri Titration.
2.0 Scope
The scope of this protocol is to verify the method for the determination of water content in
Bimatoprost by Coulometri Titration. This Method was provided by SamChunDang Pharm
Co., Ltd, which has to be verified at Vimta Labs Limited before using for routine analysis.
Method verification shall be performed for Method Precision parameter.
3.0 Details of Instruments / Equipment’s, Reagents, Sample and Standard

Instruments / Equipment’s
 Analytical balance
 Coulometer
Reagents
 Ethanol
 Hydranal coulomat
Sample
 Bimatoprost
Standard
 0.1 % Water Standard
4.0 Method of Analysis
Note: As per Vimta SOP No.: 70/30 before and after experiment system suitability has to
be performed.
Blank:
Accurately transfer 1.0 ml of absolute ethanol into titration vessel, Determine the water
content by Karl-Fischer Coulometer. Perform blank determination in duplicate and
calculate the average value.
Test solution:
Weigh 50 mg of sample dissolved in 1 mL of absolute ethanol. Determined by Karl-Fischer
Coulometer.
Page 3 of 5
Water calculate
100 % x (M - B) / (wt x 1000)
M : Sample titration
B : Blank titration
Wt : Weight of the sample
Acceptance Criteria:
≤ 1.00 %
5.0 Verification Plan
 For the determination of water content in Bimatoprost by Coulometric Titration,
following parameter is to be verified.
S. No. Verification Parameter

1 Method Precision
6.0 Analytical Method Verification
6.1 Method Precision
The precision is the degree of agreement among individual sample results when the
procedure is applied repeatedly to multiple sample portions of a homogeneous sample.
Prepare samples six times seperately.
Note: Procedure for preparation refer Section Number: 4.0.
Sequence shall be in the following manner
S. No. Name of the Preparation No. of determinations

1 Blank 02
2 Sample Preparation-1 01
Acceptance criteria
 Water content (%) determinations from each sample preparation should be ≤ 1.00 %
 If water content (%) determinations of six sample preparations are between 0.50 %
to 1.00 % then %RSD should be not more than 30 %.
Page 4 of 5
 Report the results, if the water content (%) determination from any one sample
preparation is found to be less than 0.50 % from six sample preparation determinations.
7.0 References
 SOP No.: 02/96, Verification of Compendial and customer methods / procedures.
 As per USP <921>
 STP and Specification No.: 022200, Revision No.: 000
 Procedural document request form No.: DRF2400704
8.0 Incidents, Amendments and Deviations
If any incidents and deviations occurred in the method verification, will be captured in
method verification report.
9.0 Terms and Abbreviations
The following table lists terms and abbreviations which are used in the protocol:
Terms Abbreviations
CMP Customer/Compendial Method Verification Protocol
CSP Customer Supplied Procedure
mg milligram
VLS Vimta life sciences
% Percentage
USP United States Pharmacopoeia
VLL Vimta Labs Ltd
mL Milliliter
g Gram
S.No Serial Number
STP Standard Test Procedure
RSD Relative Standard Deviation
SOP Standard Operating Procedure
wt Weight
NMT Not more than
Page 5 of 5

Bimatoprost MVP

Uploaded by

Copyright:

Available Formats

Bimatoprost MVP

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Bimatoprost MVP

Uploaded by

Copyright:

Available Formats

Protocol No.: CMP/CSP/24/0038/1.

Product Name Bimatoprost

Batch Number/Lot Number E030 235BA01

SamChunDang Pharm Co., Ltd Approvals

Function Name Designation & Department Signature & Date

1.0 Objective .............................................................................................................................. 3

6.1 Method Precision .................................................................................................................. 4

7.0 References ............................................................................................................................ 5

3.0 Details of Instruments / Equipment’s, Reagents, Sample and Standard

S. No. Verification Parameter

S. No. Name of the Preparation No. of determinations

You might also like