Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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SPECIFICATION |
Test Items | USP 40 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 | >90.0% (10.0%Water Solut.-450nm) |
Absorb | <0.25a.u. (10.0% Water Solut.-280nm) |
Specific RotationαD20 | +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 |
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 |