Item | Standard of JP16 | Standard of USP38 |
Characteristics | A white crystalline powder, odorless | |
Identification | Positive | Positive |
Clarity and color of solution | Clear and colorless | ———- |
Chloride | 0.011% max | 0.05% max |
Sulfate | 0.010% max | 0.03%max |
Ammonium | 0.02% max | ———– |
Heavy metals | 10 ppm max | 15ppm max |
Iron | 10ppm max | 30ppm max |
PH | 4.1~5.6 | ———- |
Related substances | Meet to requirement | ———- |
Loss on drying | 0.20%(105℃, 2 hours) max | 0.3%(105℃, 3 hours) max |
Residue on ignition | 0.1% max | 0.3%max |
Assay (dried) | 99.0%~101.0% | 98.5%~101.5% |
Total plate count | NMT 100/g | NMT 1000/g |
Mold | NMT 50/g | NMT 50/g |
Yeast | NMT 50/g | NMT 50/g |
Salmonella | Negative/385g | Negative/385g |
Staphylococcus aureus | Negative/25g | Netative/25g |
Related compounds | Meet to requirement | 0.5% max |
Residual solvents | ———– | Meer to requirement |
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