Item | Stabilizer agent |
Vitamin A Palmitate Oil 1.0M | None |
Vitamin A Palmitate Oil 1.0M | Toc. |
Vitamin A Palmitate Oil 1.0M | BHT |
Vitamin A Palmitate Oil 1.7M | None |
Vitamin A Palmitate Oil 1.7M | Toc. |
Vitamin A Palmitate Oil 1.7M | BHT |
Item | specification |
Description | a fat-like, light Yellow solid or a yellow oily liquid, EP/Refer to FCC |
ldentification
Thin-Layer Chromatoqraphy |
Must conform, EP/USP/FCC |
Related Substances
A300/A326 A350/A326 A370/A326 |
≤0.60, EP ≤0.54, EP ≤0.14, EP |
Chroma | ≤3.0, In house |
Retinol | ≤1.0%, EP |
All trans-isomer Content | ≥95.0%, in house |
Acid value | ≤2.0 mg/kg, EP |
Peroxide value | ≤10.0 meq/kg, EP |
Heavy metals(as Pb) | ≤5mg/kg, Ch.P |
Lead | ≤2mg/kg, FCC |
Arsenic | ≤1mg/kg, Ch.P |
Cadmium | ≤1mg/kg |
Mercury | ≤1mg/kg |
Residual solvent (ICH Class 3) | ≤5,000mg/kg, Ch.P |
Microbiological Tests | |
Total aerobic microbial count | ≤1000 cfu/g, USP |
Total mold & yeast count | ≤100 cfu/g |
Coliforms | ≤3mpn/g |
E.Coli | ≤10 cfu/g |
Salmonella | n.d./25g |
Staphylococcus aureus | n.d./25g |
Assay | |
Expressed as international units | ≥1,000,000 IU/g, EP/USP |
Expressed as equivalent amount of retinol | ≥300 mg/kg, EP/USP |
Item | specification | Result |
Description | a fat-like, light Yellow solid or a yellow oily liquid, EP/Refer to FCC | Conform |
ldentification
Thin-Layer Chromatoqraphy |
Must conform, EP/USP/FCC |
Conform |
Related Substances
A300/A326 A350/A326 A370/A326 |
≤0.60, EP ≤0.54, EP ≤0.14, EP |
0.58 0.52 0.12 |
Chroma | ≤3.0, In house | 2.0 |
Retinol | ≤1.0%, EP | n.d. |
All trans-isomer Content | ≥95.0%, in house | 97.9% |
Acid value | ≤2.0 mg/kg, EP | 0.60mg/kg |
Peroxide value | ≤10.0 meq/kg, EP | 1.9 meq/kg |
Heavy metals(as Pb) | ≤5mg/kg, Ch.P | < 5 mg/kg |
Lead | ≤2mg/kg, FCC | < 0.08 mg/kg |
Arsenic | ≤1mg/kg, Ch.P | < 1 mg/kg |
Cadmium | ≤1mg/kg | conform |
Mercury | ≤1mg/kg | conform |
Residual solvent (ICH Class 3) | ≤5,000mg/kg, Ch.P | 368.1 mg/kg |
Microbiological Tests | ||
Total aerobic microbial count | ≤1000 cfu/g, USP | < 10 cfu/g |
Total mold & yeast count | ≤100 cfu/g | < 10 cfu/g |
Coliforms | ≤3mpn/g | < 3.0 cfu/g |
E.Coli | ≤10 cfu/g | < 10 cfu/g |
Salmonella | n.d./25g | n.d./25g |
Staphylococcus aureus | n.d./25g | n.d./25g |
Assay | ||
Expressed as international units | ≥1,700,000 IU/g, EP/USP | 1,810,000 IU/g |
Expressed as equivalent amount of retinol | ≥300 mg/kg, EP/USP | 543.0 mg/g |
1. We understand the industry, the competitive landscape of the product, the current state of production, and the characteristics of the product.