Biotin
Biotin (D-biotin) is a sulfur-containing B vitamin, a white crystalline powder that is only slightly soluble in water. Commercial biotin is made by multi-step chemical synthesis and is extremely potent, with amounts per serving in micrograms. For that reason most brands buy it pre-diluted, usually as a 1% trituration on dicalcium phosphate, maltodextrin or microcrystalline cellulose, rather than as pure crystals, which call for careful handling and geometric dilution.
Suppliers sell different products under the same name. Specify the one you need.
Crystalline biotin at high purity, used by premix makers and manufacturers who dilute it themselves.
Biotin spread on dicalcium phosphate, maltodextrin or microcrystalline cellulose at 1%, the most common form for tablets and capsules.
Biotin dispersed in a soluble carrier for beverages and drink mixes.
Lower-concentration triturations for animal nutrition; not for human food or supplements.
Compare each result with your own specification when the lot arrives.
Biotin is stable as a dry powder; keep it in closed containers in a cool, dry place away from light. Suppliers set shelf life or a retest date, with assay as the usual retest check.
For triturations, record the actual assay for each lot and dose from it, since small differences matter at microgram levels. Keep pure biotin and diluted grades as clearly separate items to avoid a hundredfold dosing error.
Facts from regulators and standards bodies, each linked to its source.
21 CFR 182.8159 lists biotin as generally recognized as safe when used in accordance with good manufacturing practice.
Source: ecfr.gov (opens in a new tab)Health Canada's Multi-Vitamin/Mineral Supplements monograph lists biotin as a source ingredient for biotin.
Source: webprod.hc-sc.gc.ca (opens in a new tab)21 CFR 101.9(c)(8)(iv) sets the Reference Daily Intake for biotin at 30 mcg for adults and children 4 years and older.
Source: ecfr.gov (opens in a new tab)This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.
Manufacturers and distributors whose own websites say they sell it.
Manufacturer · Nanjing, China
Nanjing-based maker and marketer of ingredients for food, nutrition, personal care and feed. Its food and nutrition range includes vitamin C and the main B vitamins in several forms.
Suppliers are in alphabetical order and none pays to appear. Each claim is checked against the supplier’s own website on the date shown. Ask for the specification sheet and a recent COA before you order, and confirm details with the supplier.
Common forms include pure D-biotin, 1% trituration, water-soluble spray-dried powder and feed grade. Ask each supplier for the specification sheet of the exact grade they quote.
Expect assay (HPLC), identity and specific rotation, content uniformity (triturations), loss on drying, heavy metals and microbiology, each with its method, specification and result for that lot.
Biotin is stable as a dry powder; keep it in closed containers in a cool, dry place away from light. Suppliers set shelf life or a retest date, with assay as the usual retest check.
21 CFR 182.8159 lists biotin as generally recognized as safe when used in accordance with good manufacturing practice. Health Canada's Multi-Vitamin/Mineral Supplements monograph lists biotin as a source ingredient for biotin. 21 CFR 101.9(c)(8)(iv) sets the Reference Daily Intake for biotin at 30 mcg for adults and children 4 years and older.
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