Item

Specification

Appearance

White or off-white powder

Product description

Biotin, D-biotin, Vitamin H

Identification

1)A:   2)B:   3)C:

Assay

NLT97.5% and NMT 100.5%

Impurities

Individual impurity: NMT 1.0%

Total impurities: NMT2.0%

Specific rotation

+89° to +93°

Residual solvents

Meet USP and ICH Q3C requirements

Melting range

229-233℃

Loss on drying

NMT0.5%

Bulk density

~ 0.35g/cm3

Sulfate ash

NMT0.1%

Heavy metals

In line with USA Legislation

Pb: max 0.5ppm

As: max 1ppm

Cd: max 1ppm

Hg: max 0.1ppm

Dioxin

Max: 0.75ng/kg

Microbials test

In line with china legislatin

Total plate count: NMT 1000cfu/g

Yeast and mold: NMT 100cfu/g

Salmonella: negative

E.coli: negative

S. Aureus: negative

Total Coli: NMT 50cfu/g

Solubility

Very slightly soluble in water