CAS:135326-55-5
Storage:Maintain temperature under 20°C on dry environment.
Usage Life:36 months
The detailed specifications are as below:
Items | Standard |
Characters | White or almost white powder |
Solubility | Soluble in water, lightly soluble in methanol, undissolved in aether, acetone and chloroform |
Identification | Positive reaction |
pH | 5.0-7.0 |
Related Substance | NMT3.0% |
Loss on drying | NMT 2.0% |
Residue on ignition | NMT 0.3% |
Heavy metal | NMT 20ppm |
Clarithromycin rotation | -94° to-102° |
Assay Clarithromycin | NLT 608μg/mg O.D.B. |
Residual solvent | Acetone≤5000ppm |
Bacteric Endotoxin | ≤0.47Eu/mg |
Microbial testing | Escherichia coli:Absent/g |
Total aerobic microbial count:<100cfu/g | |
Total coliform count:<10cfu/g | |
Total yeasts and molds count:<10molds/g | |
Pseudomona aeroginosa:Absent/g | |
Staphylococcus aureus:Absent/g | |
Salmonella s.p:Absent/g |