GENTRY PHARMACEUTICALS LTD.

Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD TEST PROCEDURE OF RAW MATERIAL-ACTIVE INGREDIENT
Name of Material CHOLINE BITARTRATE BP
Document No.: STP/RMA004 Revision No. 01 Superseded No.: 01

Issue Date 01.07.2018 Effective Date: 10.07. 2018 Review Date: 10.07. 2021

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

CONTENT
1. Appearance
2. Solubility
3. Identification
4. PH
5. Water
6. Residue On Ignition
7. Assay
8. Revision History

ATTACHMENTS

1. Specification [SPEC/RMA004]
2. Specimen COA

DISTRIBUTION LIST

Section No. of Copy Received By (Signature & Date)

QC Laboratory 01

Page 1 of 4
WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER
DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED
 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD TEST PROCEDURE OF RAW MATERIAL-ACTIVE INGREDIENT
Name of Material CHOLINE BITARTRATE BP
Document No.: STP/RMA004 Revision No. 01 Superseded No.: 01

Issue Date 01.07.2018 Effective Date: 10.07. 2018 Review Date: 10.07. 2021

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

Sl. No. Test Parameters Procedure BP

01. Appearance White hygroscopic, crystalline powder.

Freely soluble in water; slightly soluble in alcohol, insoluble in ether and

02. Solubility
chloroform.
A. Infrared Absorption
B.Dissolve 1 gm of Choline Bitartrate with 20 ml of water, add 2 ml of
03. Identification potassium chloride solution (1 in 4). A white precipitate of potassium
bitartrate is formed.
C. Melting Point: Melts Between 148 ̊C to 153 ̊C.

04. PH Between 3 to 4 in a solution (1 in 10)

05. Water Not more than 0.5 %

06. Residue on Ignition Not more than 0.1 %

Procedure— Ignite a suitable crucible (for example, silica, platinum, quartz,
or porcelain) at 600 ± 50 for 30 minutes, cool the crucible in a desiccator

Page 2 of 4
WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER
DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED
 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD TEST PROCEDURE OF RAW MATERIAL-ACTIVE INGREDIENT
Name of Material CHOLINE BITARTRATE BP
Document No.: STP/RMA004 Revision No. 01 Superseded No.: 01

Issue Date 01.07.2018 Effective Date: 10.07. 2018 Review Date: 10.07. 2021

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

(silica gel or other suitable desiccant), and weigh it accurately. Weigh

accurately 1 to 2 g of the substance, or the amount specified in the
individual monograph, in the crucible.

07. Assay
Choline Bitartrate contains not less than 99% and not more than 100.5%
C9H19NO7 on the anhydrous Basis.
Transfer About 200 mg of Choline Bitartrate, Accurately weighted, to conical
flask, and dissolve with 50 ml of Glacial acetic acid. Titrate with 0.1N
Perchloric Acid VS, Determining the endpoint potentiometrically.Perform
blank determination,and make any necessary correction.Each ml of 0.1N
Perchloric acid is equivalent to 25.32 mg of Choline Bitartrate.

% Content of Choline Bitartrate

(V2-V1) × F × 25.32
=------------------------------- × 100
W

Here,
W= Weight of Sample
V1= Initial Burette Reading
V2= Final Burette Reading
F = Factor of Titrant

Page 3 of 4
WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER
DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED
 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD TEST PROCEDURE OF RAW MATERIAL-ACTIVE INGREDIENT
Name of Material CHOLINE BITARTRATE BP
Document No.: STP/RMA004 Revision No. 01 Superseded No.: 01

Issue Date 01.07.2018 Effective Date: 10.07. 2018 Review Date: 10.07. 2021

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

08. Revision History

Document No. Version No. Date Reason

To update the detail procedure of analysis for Choline

STP/RMA004 01 01.07.2018
Bitartrate BP

Page 4 of 4
WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER
DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED