D-Biotin vitamin

Product Description
D-Biotin is a synthesis product, a white or almost-white crystalline powder, hardly soluble in water and ethanol, practically insoluble in acetone. It dissolves in dilute solutions of alkali hydroxides.
Product Identification
Synonym Vitamin H
CAS No. 58-85-5
EINECS No. 200-399-3
INCI name Biotin
Chemical Formula: C10H16N2O3S
Specifications Molecular Weight: 244.31
Description
White or almost-white crystalline powder or colorless crystals
Identification
IR
To match with the Reference IR Spectrum
TLC
The principal spot in the chromatogram obtained with test solution(b) is similar in position and size to the principal spot in the chromatogram obtained with reference solution(a)
Color Reaction
The bromine water is decolorized
Specific Rotation (Calculated with reference to the dried substance)
+89° ~ +93°
Appearance of solution
Clear and colorless
Related substances
To conform
Loss on drying
≤ 1.0%
Sulphated ash
≤ 0.1%
Heavy metals (as Pb)
≤ 10 ppm
Arsenic*
≤ 3 ppm
Pb*
≤ 2 ppm
Hg*
≤ 0.1 ppm
Cd*
≤ 1 ppm
Assay
98.5% ~100.5%
Microbiological tests
Total viable aerobic count*
≤ 1000 cfu/g
Total yeasts and moulds count*
≤ 100 cfu/g
Escherichia coli*
N. D.
Salmonella species*
N. D.
Pseudomonas aeruginosa*
N. D.
Staphylococcus aureus*
N. D.
Compendial requirements
The D-Biotin crystalloid meets all requirements of the relevant monographs of FCC, USP and Ph. Eur. When tested according to these compendia.
Storage and Stability
The product may be stored for 36 months from the date of manufacture in the unopened original container at room temperature.
It should be protected from light, heat, oxygen and moisture. Keep the container tightly closed. Once opened, use contents quickly.
Uses
As an essential nutrient for human body, widely used for dietary supplements and fortified foods, also used for tablets and hard-shell capsule preparations due to its pharmaceutical properties.
Safety
This product is safe for the intended use. Avoid ingestion, inhalation of dust or direct contact by applying suitable protective measures and personal hygiene.
See Material Safety Data Sheet for full safety information.
The country of origin
China