Product Description
GMP, SGS Certified With Purity Guarantee.
-1, Product Name: Biotin (Vitamin H)
-2, Specification & Standard: 98.5 - 101.0% USP /EP /BP
-3, CAS #: 58-85-5
-4, MF: C10H16N2O3S / MW: 244.31
-5, Description: Colorless to nearly colorless crystalline powder.
-6, Function:
A- To assist the metabolism of amino acids and carbohydrates.
B- Promote the normal operation and growth of sweat glands, spiritual organizations, bone marrow, the male gonads, the skin and hair.
C- Prevent white hair and hair loss, help to cure baldness.
D- Used for missing biotin enzyme (Biotinidase) children.
E- Maintain normal function of skin; Relieve eczema and skin irritation symptoms.
Melting point 232-233° C, 25° C, when the solubility (mg/100ml): Water --22; 95% ethanol --80.
More easily soluble in hot water and dilute alkali solution, insoluble in other common organic solvents, when the decomposition of alkali or oxidizing agent.
Biotin is known for vitamin B7 or vitamin H. It is beneficial for the following conditions:
1, Hair loss
2, Brittle nails
3, Seborrheic dermatitis in infants
4, Diabetes
5, High cholesterol
6, Depression
Specification:
| Items | Specifications | Results |
| Appearance | White or off-white powder | Conforms |
| Product description | Biotin, D-Biotin, vitamin H. | Conforms |
| Identification | 1)A: 2)B: 3)C: | Conforms |
| Assay | NLT97.5% and NMT100.5% | 99.21% |
| Impurities | Individual impurity: NMT 1.0% Total impurities: NMT 2.0% Total impurities: NMT 2.0% | Conforms |
| Specific rotation | +89 - +93° | +90.09° |
| Residual solvents | Meet USP and ICH Q3C requirements | Conforms |
| Melting range | 229-233ºC | 229.4-230.1ºC |
| Loss on Drying | NMT 0.5% | 0.21% |
| Bulk density | ~0.35g/cm3 | Conforms |
| Sulfate ash | NMT 0.1% | 0.020% |
| Heavy Metals | In line with USA legislation(USP) Pb≤0.5ppm As≤1ppm Cd≤1ppm Hg≤0.1ppm | Conforms 0.05ppm 0.5ppm 0.01ppm 0.006ppm |
| Dioxin | WHO-PCDD/F-TEQ/KG product ≤0.75ng/kg | Conforms |
| Particle size | 50% min. <10μm 90% min. <20μm 98%min. <30μm | Conforms |
| Microbials test | In line with China legislation Total plate count≤1000cfu/g Yeast and mold≤100cfu/g Salmonella: Negative E.Coli: Negative S.Aureus: Negative Total Coli: ≤50cfu/g | Conforms 10 cfu/g 5 cfu/g Negative Negative Negative |
| Solubility | Very slightly soluble in water | Conforms |
| Storage & Shelf life | 24 months from date of manufacturing in original Unopened packaging, store in tight containers | Conforms |
