Product Introduction
Biotin (D‑biotin) is a water‑soluble B‑vitamin that functions as a covalently bound cofactor for five mammalian carboxylases: acetyl‑CoA carboxylase, propionyl‑CoA carboxylase, β‑methylcrotonyl‑CoA carboxylase, pyruvate carboxylase, and holocarboxylase synthetase. These enzymes mediate key steps in fatty acid synthesis, gluconeogenesis, branched‑chain amino acid catabolism, and cellular energy production.
Biotin supports keratin biosynthesis and epithelial tissue maintenance, which underpins its use in hair, skin, and nail formulations. Endogenous biotin is partially synthesized by intestinal microbiota; exogenous supplementation supports metabolic homeostasis in deficient states.
Technical Specification
| Item | Standard | Result |
|---|---|---|
| Description | White or almost‑white crystalline powder | Complies |
| Identification (IR) | Conforms to reference standard | Conforms |
| Specific Rotation | +89° ~ +93° | +91° |
| Assay (on dried basis) | 97.5% – 102.0% | 99.2% |
| Total Impurities | ≤2.0% | 0.54% |
| Benzene | ≤2 ppm | <0.2 ppm |
| Toluene | ≤100 ppm | <10 ppm |
| Total Aerobic Microbial Count | ≤1000 cfu/g | Complies |
| Total Molds & Yeasts | ≤100 cfu/g | Complies |
| Escherichia coli | Not detected / 1 g | Complies |
| Staphylococcus aureus | Not detected / 1 g | Complies |
| Enterobacteriaceae | Not detected / 1 g | Complies |
| Salmonella | Not detected / 10 g | Complies |
Safety Profile
- Acute oral LD₅₀ in rats: >10 g/kg; no acute toxicity observed at typical use levels.
- No established upper limit (UL) for oral biotin; doses up to 10–50 mg/day are well‑tolerated in humans without toxic effectsOffice of Dietary Supplements (ODS).
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High doses (≥5 mg/day) may interfere with biotin‑streptavidin immunoassays (thyroid function, troponin, 25‑hydroxyvitamin D), causing false‑high or false‑low results; discontinue 48–72 hours prior to diagnostic testing.
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Cosmetic topical use up to 0.6% is considered safe.
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Hypersensitivity to biotin or formulation excipients is a contraindication.
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Pregnancy and lactation: safe at dietary reference intakes; high‑dose supplementation not recommended without professional supervision.
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Certifications: ISO9001, FSSC22000, Kosher, Halal, Non‑GMO, Allergen‑Free, Non‑Irradiated.
Applications
1.Dietary Supplements & Functional Foods
- Oral use for biotin deficiency support; max dose ≤15 mg/day for adults.
- Not for self‑medication in children <11 years without professional guidance.
2.Cosmetics & Personal Care
- Hair/skin/nail conditioners; topical concentration ≤0.6%.
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Not for injectable, oral, or wound‑contact formulations.
3.Animal Nutrition
- Livestock/poultry feed to improve hoof health, feather quality, and reproductive performance.
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Use only in complete feed; follow regional maximum inclusion limits.
4.Pharmaceutical Formulations
- For licensed drug compounding only; comply with local pharmacopeia and dosage regulations.
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Not for unapproved clinical indications.
Why Choose Us
- Stable High Purity
Consistent 99.0%+ assay with tight impurity control, compliant with USP standards.
- Full Regulatory Compliance
ISO9001, FSSC22000, Kosher, Halal, Non‑GMO, Allergen‑Free, with full COA and MSDS.
- Large‑Scale Reliable Supply
25,000 ㎡ GMP production base; annual capacity >6,000 tons; stable lead times.
- Strict Quality Control
In‑house lab testing for heavy metals, solvents, microbes, and chiral purity.
- Global Logistics & Customization
Export to 50+ countries; flexible packaging (1 kg–25 kg); OEM/ODM available.
- Technical Support
Custom formulation guidance, stability data, and regulatory documentation support.
Deliver, shipping and serving
Storage: Store in a dry, cool, and well-ventilated place.
Packaging: 1 kg/bag, 25 kg/drum
Delivery Time: 7 days after order placement
1.Express Delivery
3-5 days for shipments under 100 kg
Door-to-door service
2.Ocean Freight
Over 300 kg: Approximately 30 days. Port-to-port service requires a professional customs clearance agent.
3.Air Freight
100kg-1000kg, 5-7 days
Airport-to-airport service, requires a professional customs clearance agent
Everything You Need to Know
Is Biotin Pure 99% suitable for vegan and halal/kosher products?
Yes. Our product is vegan, non‑GMO, allergen‑free, and certified Kosher and Halal.
What is the maximum recommended use level in food supplements?
For adult oral supplements, typical use is 300 mcg–15 mg per day; follow local food supplement regulations.
Can this grade be used in topical cosmetics?
Yes. It is cosmetic‑grade and safe for leave‑on/rinse‑off hair and skin products at ≤0.6%.
How long is the shelf life under proper storage?
24 months when stored sealed, dry, away from light and heat (≤25°C).
Send inquiry or contact us to get free sample, and learn more details about it.
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