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Department Document No.

Innvotek Pharmaceuticals Quality Control IP- QCD-SAPI-012


Effective Date Next Revision Date
Standard Analytical Procedures 07-03-2020 06-03-2023
Revision Date Revision No.
Opashine White 01-03-2020 03
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Control Analyst Quality Control Manager Quality Assurance Manager Production/Plant Manager

1. Raw Material Specification:


S# Test Specification Ref. Specification Ref. Method

White to almost
01. Appearance white, crystalline B.P B.P
powder.

Insoluble in water
forms a suspension
02. Solubility with methylene B.P B.P
chloride and
isopropyl alcohol.

Bulk;0.503g/cm2
03 Density Innvotek Innvotek
Tapped;0.723g/cm2

NMT 5% at 105°C
04 Loss On Drying B.P B.P
for 1 hours.

5 - 8
05 B.P B.P
pH 2% w/w in water

06 Identification Positive B.P B.P

Controlled Copy: Do not Duplicate Page 1 of 3


Department Document No.
Innvotek Pharmaceuticals Quality Control IP- QCD-SAPI-012
Effective Date Next Revision Date
Standard Analytical Procedures 07-03-2020 06-03-2023
Revision Date Revision No.
Opashine White 01-03-2020 03
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Control Analyst Quality Control Manager Quality Assurance Manager Production/Plant Manager

2.0 PURPOSE

This document is established to define the method of analysis for incoming raw
material Opashine white to confirm its physical and chemical properties against
raw material specification.

3.0 SCOPE

This procedure is applicable in Quality Control Department for the analysis of


incoming Opashine white.

4.0 PROCEDURE

PHYSICAL ANALYSIS
4.1 Appearance:
White to almost white, crystalline powder.
4.2 Solubility:
Insoluble in hot water forms a suspension with methylene chloride and isopropyl
alcohol and cold water.
4.3 Loss On drying:
NMT 5% at 105°C for 1 hours.
4.4 pH:
5 - 8(2%/ w/w solution in water)
4.5 Identification:

Dissolve 50mg in 5ml mixture of methylene chloride and isopropyl alcohol on


evaporating a thin film is develops.

Controlled Copy: Do not Duplicate Page 2 of 3


Department Document No.
Innvotek Pharmaceuticals Quality Control IP- QCD-SAPI-012
Effective Date Next Revision Date
Standard Analytical Procedures 07-03-2020 06-03-2023
Revision Date Revision No.
Opashine White 01-03-2020 03
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Control Analyst Quality Control Manager Quality Assurance Manager Production/Plant Manager

5.0 REFERENCE DOCUMENTS

British Pharmacoepoeia 2012

6.0 Records

Document No. Description Retention Time


4-QCD-001 Certificate of analysis Raw Material 05 years
4-QCD-005 Approved Label Raw Material 5 years

7.0 Distribution List


Received Returned
Copy No. Distributed to
(Current) (Obsolete)
01 Quality Assurance Department
02 Quality Management Department
03 Quality Control

8.0 Revision History


Revision No. Description
00 New Document
01 Revision due, Addition of new format
02 Revision due, change in format
03 Change in format.

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