Overview
Sodium D-Biotin is the sodium salt form of D-Biotin, a water-soluble B-vitamin (B7) critical for cellular metabolism, fatty acid synthesis, and gluconeogenesis. Its enhanced solubility makes it preferable for formulations requiring rapid absorption, such as injectables or fortified foods. The compound is synthesized through the neutralization of biotin with sodium hydroxide, yielding a stable salt with consistent bioavailability. It is widely regulated as a dietary supplement ingredient (e.g., FDA 21 CFR 184.1090) and holds GRAS (Generally Recognized As Safe) status for food applications.
Physical and Chemical Properties
Sodium D-Biotin appears as a white crystalline powder with no discernible odor. It exhibits high thermal stability but decomposes at temperatures exceeding 230°C. The sodium salt modification significantly improves its solubility in water (up to 50 mg/mL) compared to free biotin, which is only sparingly soluble. Chemically, it acts as a coenzyme for carboxylase enzymes, facilitating carboxylation reactions in metabolic pathways. Its stability under physiological pH ranges (4–9) makes it suitable for oral and topical formulations. Spectroscopic methods (e.g., UV, IR) are employed for quality verification.
Main Applications
In pharmaceuticals, Sodium D-Biotin is used in multivitamin preparations and IV therapies to address biotin deficiency, which can cause dermatological or neurological disorders. It is also added to prenatal vitamins due to its role in embryonic development. The cosmetic industry incorporates it into hair growth serums and skin repair creams, leveraging its keratin production stimulation. In animal nutrition, it enhances livestock growth rates and feather quality in poultry. Industrial fermentation processes may utilize it as a microbial growth factor.
Safety and Storage
While Sodium D-Biotin is non-toxic (LD50 >2,000 mg/kg in rats), workplace exposure should be minimized using PPE (gloves, goggles). Spills require prompt cleanup with water to prevent slip hazards. Long-term storage mandates airtight containers with desiccants to prevent clumping. Shelf life typically exceeds 24 months under recommended conditions. Stability testing (ICH Q1A) is advised for sensitive formulations, particularly sterile products.
B2B Procurement Guide
Industrial buyers should prioritize suppliers with cGMP compliance and batch-specific Certificates of Analysis (CoA). Key parameters to test include assay purity (≥98%), heavy metal content (<10 ppm), and residual solvents (per ICH Q3C). Bulk orders (25+ kg) often qualify for tiered pricing. Consider regional regulations: USP/NF standards apply in North America, while EP monographs govern European markets. Logistics should ensure temperature-controlled transit if exceeding 30°C ambient conditions.
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