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Tests | Limits |
Appearance | White crystalline , free flowing powder |
Bulk Density | NLT 0.45g/ml |
As Tapped Density | Meets the requirements of USP32 |
Particle Size | 100% through 100mesh |
Assay(HPLC) | 98.0 ~102.0% (on the dried basis) |
Specific Rotation | +39.0°~ +43.0° |
Ph(20mg/ml.aq.sol.) | 6.0~8.0 |
Loss on drying | NMT0.5% |
Residue on ignition | NMT0.1% |
Chloride(Cl) | NMT0.2% |
Melting point | 196°C~205°C |
Heavy metals | NMT10ppm |
Iron(Fe) | NMT10ppm |
Lead | NMT0.5ppm |
Arsenic(As) | NMT0.5ppm |
Mercury | NMT0.5ppm |
Organic volatile impurities | Meets the requirements |
Total Aerobic | NMT 1000cfu/g |
Yeast & Mold | NMT 100cfu/g |
E.Coli | Negative in 1g |
Salmonella | Negative in 1g |
Staphylococcus Aureus | Negative in 10g |
Enterobacteria & other gram neg | NMT 100cfu/g |
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