Customization: | Available |
---|---|
Function: | Urinary System Agents |
Certification: | GMP |
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Audited by an independent third-party inspection agency
Items | Specification |
Appearance | white crystalline powder |
Identification | conformed to the standard |
Acidity | conform |
Melting point | 166-170 o C |
Solution clarification | conform |
Chloride | <0.003% |
Sulphate | <0.01% |
Oxalate | <0.02% |
Loss on drying | <0.5% |
Residue on ignition | <0.1% |
Heavy metals | <10ppm |
As | <2ppm |
Assay | 98.0-102.0% |
BP2015 Standard
Items |
Specification |
Appearance |
white or almost white crystals or powder |
Solubility |
freely soluble in water, practically insoluble in ethanol(96%) |
Identification |
Specific rotation +23o - +25o |
|
Melting point 165-170oC |
|
Infrared absorption conform |
Appearance of solution |
clear & colorless |
Conductivity |
≤20μS/cm |
Reduce sugar |
≤0.1% |
Related substances |
A(Sorbitol) ≤2.0% |
|
B+C(Maltitol+ Isomalt) ≤2.0% |
|
Unspecified ≤0.1% |
|
Total ≤2.0% |
Heavy metal |
≤5ppm |
Nickel |
≤1ppm |
Loss on drying |
≤0.5% |
Microbiological |
Total aerobic count ≤103cfu/g |
|
Yeast&mold ≤102cfu/g |
|
E.Coli negative |
|
Salmonella negative |
Assay |
97.0-102.0% |
Bacterial endotoxin |
≤2.5EU/g |