| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Test Items | USP 43 Standard specifications |
| Properties (physical): | |
| Appearance | White Crystalline, Free Flowing Powder |
| Odour | Odourless |
| Bulk Density | NLT0.60g/ml |
| As Tapped Density | Meets the requirements of USP32 |
| Particle Size | NLT 90% through 40 Mesh |
| Analytical Properties: | |
| Assay (HPLC) | 98.0-102.0% (on the dried basis) |
| Identification | |
| A: Infrared Absorption | Meets the requirement |
| B: Tests for Chloride | Meets the requirement |
| C: Retention time in the Assay | Corresponds to the reference standard |
| Transm | NLT 90.0% (10.0%Water Solut.-450nm) |
| Absorb | NMT 0.25a.u. (10.0% Water Solut.-280nm) |
| Specific Rotation(α)D20 | +70.00°--+73.00° |
| pH (20mg/ml.aq.sol.) | 3.0--5.0 |
| Loss on Drying | NMT0.5% |
| Residue on Ignition | NMT 0.1% |
| Chloride (Cl) | 16.2% -- 16.7% |
| Sulfate | NMT 0.24% |
| Heavy Metals | NMT 10 ppm |
| Iron (fe) | NMT 10 ppm |
| Lead | NMT 0.5 ppm |
| Arsenic (As) | NMT 3.0 ppm |
| Mercury | NMT 0.5 ppm |
| Organic volatile impurities | Meets the Requirements |
| Microbial: | |
| Total Aerobic | NMT 1,000 cfu/g |
| Yeast and Mold | NMT 100 cfu/g |
| E. Coli | Negative in 1g |
| Salmonella | Negative in 1g |
| Staphylococcus Aureus | Negative in 10g |
| Enterobacteria & other gram neg | NMT 100 cfu/g |
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