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Test Item | Specification(U.S.P32) |
Assay | Not less than 98% of C58H90O4 calculated on the anhydrous basis |
Description | Yellow to orange crystalline powder |
Identification | Color Reaction:a blue color appears IR |
Water | ≤0.2% |
Residue on ignition | ≤0.1% |
Particle size | Not less than 90% pass 80 mesh |
Heavy metals | ≤0.002% |
| Chromatographic purity | Test 1:Sum of all impurities: ≤1.0% Test 2: Sum of all impurities: ≤1.0% Test 1&Test 2: Sum of all impurities: ≤1.5% |
Residual solvents | Ethanol<1000ppm;Ethyl Acetate<100ppm;Hexane<50ppm |
Standard plate count | ≤1000cfu/g |
Yeast&mold | ≤50cfu/g |
Coliforms | ≤3cfu/g |
Salmonella | Negative |
E.coli. | Negative |
S.aureus | Negative |
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