Batch No.:BC20071126

Manufacturing Date:2007.11.26

Batch Size:1200kg

Expiry Date:2009.11.25

Quantity:60kg

Analysis Date:2007.11.27

Molecular Formula:C₂₇H₄₂ClNO₂

Molecular Weight: F.W. 448.08

Storage: Keep tightly closed in light-resistant container.

Item

Specification

Result

Appearance

White crystalline powder

Consistent

Solubility

Freely soluble in aqueous solvents

Complies

Identification

A: Infrared Absorption

Complies

B: ¹H-NMR and IR

Complies

Melting range

158~163°C

161.6~162.5°C

Loss on drying

(Drying on 105°C 4hrs)

5.0%Max

3.05%

Residue on ignition

0.1%Max

0.05%

Ammonium compounds

The odor of ammonia is not perceptible

To pass the test

Heavy metals

20ppm Max

Complies

Assay (C₂₇H₄₂ClNO₂; Dried Basis)

97.0~103.0%

99.23%

 

Conclusion:  Complies With Quality Standard of USP29  

 

 

Certified By: li hui

 

Assessor: Yuying Chen