GENTRY PHARMACEUTICALS LTD.

Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD TEST PROCEDURE OF RAW MATERIAL-ACTIVE INGREDIENT
Name of Material SULFAPYRIDINE USP
Document No.: STP/RMA024 Revision No. 01 Superseded No.: 01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. Loss on Drying
5. Revision History

ATTACHMENTS

1. Specification [SPEC/RMA024]
2. Specimen COA

DISTRIBUTION LIST

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

QC Laboratory 01

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER Page 1 of 3

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 SULFAPYRIDINE USP
Document No.: STP/RMA024 Revision No. 01 Superseded No.: 01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 USP

White or faintly yellowish–white crystals, granules or Powder. Is odorless or

01. Appearance practically odorless, and stable in air, but slowly darkens on exposure to
light.
Freely soluble in dilute mineral acids and in solutions of potassium and
02. Solubility sodium hydroxides; Sparingly soluble in acetone; Slightly soluble in Alcohol;
Very Slightly soluble in water.
Infrared Absorption
Add 5 ml of 3 N Hydrochloric Acid to about 0.1g of Sulfapyridine, and boil
gently for about 5 minutes. Cool in an ice bath, add4 ml of sodium nitrate
solution (1 in 100), dilute with water to 10 ml, and place the mixture in the
03. Identification ice bath for 10 minutes. To 5 ml of the color mixture add a solution of 50 mg
of 2-Naphthol in 2 ml of sodium hydroxide (1 in 10): An orange–red
precipitate is formed, and it darkens on standing.

Malting Range Between 190 and 193.

04. Loss on Drying Dry it at 105 ̊ C for 2 hours: It loses not more than 0.5 % of its weight.

05. Assay Sulfapyridine Contains NLT 99% and NMT 100.5 % of Sulfapyridine,
Calculate on Dried Basic.

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER Page 2 of 3

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 SULFAPYRIDINE USP
Document No.: STP/RMA024 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

Proceed with Sulfapyridine as directed under Nitrite Titration. Each ml 0.1N

Sodium Nitrate is equivalent to 24.93 mg of C11H11N3O2S.

06. Revision History

Document No. Version No. Date Reason

STP/RMA024 01 June 2017 N/A

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER Page 3 of 3

DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED