Powder: | Yes |
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Customized: | Customized |
Certification: | GMP, HSE, ISO 9001, USP |
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Audited by an independent third-party inspection agency
Product name |
D-Biotin |
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CAS CAS No. |
58-85-5 |
Outer Packing |
1KG 1KG/Tin |
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Production date |
201505-16 |
Shelf life |
36months |
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Standard adopted |
QB |
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Items of analysis |
Specification |
Results |
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appearance |
White to white crystalline powder |
Conform to the |
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identify |
Should meet the requirements |
Conform to the |
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Assay |
98.5%-100.5% 98.5%-100.5% |
99.1% 99.1% |
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Loss on drying |
≤0.2% ≤0.2% |
0.1% 0.1% |
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Specific Rotation |
+89.0°- +93.0° +89.0°- +93.0° |
+89.5° +89.5° |
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Melting point |
229ºC-232ºC 229ºC-232ºC |
229.1ºC-231.3ºC 229.1ºC-231.3ºC |
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Ash |
≤0.1% ≤0.1% |
0.1% 0.1% |
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Solution color and clarity |
, Solution should be clear, the sample color should be lighter in color |
Conform to the |
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(Pb) Heavy metal |
≤10mg/kg ≤10mg/kg |
<10mg/kg <10mg/kg |
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(Pb) Lead |
≤2mg/kg ≤2mg/kg |
<2mg/kg <2mg/kg |
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(As) As |
≤1mg/kg ≤1mg/kg |
<1mg/kg <1mg/kg |
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Related substance |
≤0.5%,0.25% Total impurity≤0.5%;sole impurity≥0.25 |
Conform to the |
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Total number of colonies |
≤1000cfu/g ≤1000cfu/g |
<1000cfu/g <1000cfu/g |
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Mold and yeast |
≤100cfu/g ≤100cfu/g |
<100cfu/g <100cfu/g |
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E. coli bacteria |
(25g) not detectable(25g) |
not detected |
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salmonella |
(25g) not detectable(25g) |
not detected |
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Conclusion |
Qualified |
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