Vitamin B7 (Biotin)

Biotin, catalogued in trade as vitamin B7 or vitamin H, is a bicyclic sulphur-containing compound (C10H16N2O3S, CAS 58-85-5, molecular weight 244.31) manufactured by chemical synthesis as the biologically active D-isomer. Thovek supplies it as a white to off-white crystalline powder meeting USP (97.5-102.0% on the dried basis), Ph. Eur./BP (98.5-101.0% on the dried substance) and FCC (97.5-100.5%) requirements. Specific optical rotation of +89 to +93 degrees, measured at 20 mg/mL in 0.1 M sodium hydroxide, confirms the D-configuration; loss on drying is held to not more than 1.0% at 105 C and sulphated ash to not more than 0.1%. The material melts with decomposition at about 229-232 C. In nutrition biotin functions as the covalently bound coenzyme of the carboxylase enzymes involved in fatty acid synthesis, gluconeogenesis and the catabolism of branched-chain amino acids. Because use levels sit in the microgram range, most manufacturers work from a diluted grade: 1% and 2% triturations on dicalcium phosphate or maltodextrin give far better content uniformity in direct-compression tablets, gummies, sachets and vitamin premixes than the neat crystal. Pure biotin is only very slightly soluble in water, roughly 20 mg per 100 mL at 25 C, and in alcohol, and is practically insoluble in acetone, but it dissolves in dilute alkali hydroxide solutions - which is how liquid, effervescent and syrup systems are normally built. Every lot ships against a certificate of analysis covering identification, assay, specific rotation, loss on drying, sulphated ash, lead and microbiological limits, with residual solvent and elemental impurity data available on request. Standard export documentation includes MSDS, non-GMO, allergen and BSE/TSE statements, and halal or kosher certificates where the manufacturing site holds them. Correct classification for export from India is ITC-HS 29362950, the dedicated Vitamin H (Biotin) line, not the 29362900 catch-all.