Clindamycin hcl Clindamycin hcl Clindamycin
1. GMP AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
ITEMS |
SPECIFICATION |
RESULTS |
Characters |
A white crystalline powder |
Conform |
Solubility |
Very soluble in water,slightly soluble in ethanol (96%) |
Conform |
Identification |
Infrared Absorption |
Conform |
HPLC |
Conform |
|
Organic impurities |
Lincomycin ≤1.0% |
N.D |
Clindamycin B ≤2.0% |
0.8% |
|
7-epiclindamycin ≤4.0% |
0.4% |
|
any other individual impurity ≤1.0% |
N.D |
|
total related compounds ≤6.0% |
1.4% |
|
Crystallinity |
Meets the requirement |
Conform |
pH |
3.0~5.5 ,in a 100mg/ml solution |
4.3 |
Water |
3.0% ~6.0% |
3.8% |
Assay |
Not less than 800μg of clindamycin(C18H33ClN2O5S)per mg |
884μg/mg |
Conclusion: Conforms to USP38 standard |
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