Cefazolin Sodium (Sterile) Testing Procedure
Cefazolin Sodium (Sterile) Testing Procedure
1.0 PURPOSE
This raw material specification and analysis prescribes the requirements for Cefazolin Sodium (Sterile) which is used in Injection.
2.0 SCOPE
2.1 It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications.
2.2 Item code
3.0 REFERENCES
BP/USP/Inhouse
4.0 DEFINATIONS
Follow Sop
5.0 SPECIFICATIONS BP/USP/Inhouse
TESTS SPECIFICATIONS
1 Physical: Form Very Hygroscopic Powder
2 Colour: White or almost White
3. Solubility: Freely soluble in water, very slightly soluble in alcohol , practically insoluble in Ether.
4. Specific Optical Rotation: -15° to -24° on dried basis at 20.0°C
5 Reconstitution: 2.1 ml (±0.1 ml)
6 Reconstit...