DC4796
117772-70-0
C38H76N2O14
Azithromycin
Index Name | Specifications |
Appearance | White to off-white crystalline powder |
Assay(on dried basis) | 96.0 to 102.0% |
PH | 9.0 to 11.0 |
Water | 5.0% max |
Residue on ignition | 0.2% max |
Heavy metal | 0.0025% max |
Abnormal toxicity | Should be compliance with rule |
pressure down substance | Should be compliance with rule |
Organic solvents residue | Methanol: 0.3% max Ethanol: 0.05% max Acetone: 0.5% max Chloroform: 0.006% max |
Microorganism | Bacteria total count: 1000cfu/g Mould & saccharomycetes total count: 100cfu/g Human escherichia coli: should not be detected per gram |
Index Name | Specifications |
Appearance | White to off-white crystalline powder |
Assay(on dried basis) | 96.0 to 102.0% |
PH | 9.0 to 11.0 |
Water | 5.0% max |
Residue on ignition | 0.2% max |
Heavy metal | 0.0025% max |
Abnormal toxicity | Should be compliance with rule |
pressure down substance | Should be compliance with rule |
Organic solvents residue | Methanol: 0.3% max Ethanol: 0.05% max Acetone: 0.5% max Chloroform: 0.006% max |
Microorganism | Bacteria total count: 1000cfu/g Mould & saccharomycetes total count: 100cfu/g Human escherichia coli: should not be detected per gram |
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