D-Biotin price D-Biotin supplier D-Biotin factory
1. Hubei Jusheng Technology Co., Ltd., is a global chemical industry manufacturers and suppliers of pharmaceuticals and intermediates in China.
2. The yearly production capacity is 50000MT, 80% for export.We have a professinal export team. Both by Air and by Sea,we ensure that we meet the customer expectations with promptness.
3. Our company facing global High-tech pharmaceutical raw materials, high complex new type intermediates, fine chemicals custom synthesis, scale-up production and Rare chemicals trade. Corey have well-equipped machine, strong technical force and considerate marketing team service.
4. We also have rich experience advantage in basic research, small scale process development, scale-up, industrial technology development & production and cost control.
Product Name | Biotin | Test No. | B10020020 |
Specification | Drug Substance | Batch No. | 140502 |
Sample Source | Plant210 | Package | Drum |
MFG. Date | 2014/5/2 | Quantity | 81.5kg |
Expiry Date | 2017/5/1 | Report Date | 2014/5/4 |
Test standard | USP36 | ||
Test Items | Specification | Test Results | |
1 Appearance | A white or almost white crystalline powder | A white crystalline powder | |
Identification IR Specific Rotation [a] 25 D Retention time |
to match with the Reference IR Spectrum +89°~+93° Should be similar to that of reference solution |
Conforms +90° Conforms |
|
3 Loss on drying | ≤0.4%,in-house | 0.02% | |
residual solvents Benzene Toluene DMSO |
≤2ppm ,in-house ≤100ppm,in-house ≤5000ppm,in-house |
≤0.2ppm ≤10ppm ≤500ppm |
|
related substances Any impurity Total impurities |
≤1.0% ≤2.0% |
0.33% 0.53% |
|
microbial test Total viable aerobic count Total yeasts and moulds counts Escherichia coli Staphylococcus aureus Pseudomonas aeruginosa Enterobacteria Salmonella species |
≤1000cfu/g ,in-house ≤100cfu/g ,in-house n.d./1g,in-house n.d./1g,in-house n.d./1g,in-house n.d./1g,in-house n.d./1g,in-house |
/ / / / / / / |
|
7 Assay | 97.5%~100.5% | 98.9% | |
Conclusion | Conform to USP 36 |
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