Amodiaquine IP/BP/USP

Test Items

Specification

Test Results

Description

Yellow crystalline powder

Yellow crystalline powder

Completeness of solution

2% of water solution for this product should clear

Complies

Identification

Positive

Positive

Water

7.0%-9.0%

8.2%

Residue on ignition

0.2%

0.05%

Chromatographic purity

0.5%

0.5%

Organic volatile impurities

Alcohol 5000ppm

337ppm

(C20H22ClN3O2HCl)

Assay(C20H22ClN3O2HCl)

97.0%-

99.8%

Microbial limit

Bacteri1000 CFU/g

10 CFU/g

Fungi100 CFU/g

10 CFU/g

E. coli Should not be detected

Absent

Conclusion

The quality of the above commodity complies standard

Packaging details:

25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat

Shelf Life:

5 years if sealed and store away from direct sun light.