| PARAMETERS | LIMITS/SPECIFICATIONS | RESULTS |
| Description | a fat-like, light Yellow solid or a yellow oily liquid, EP/Refer to FCC | a fat-like, yellow oily liquid |
Identification
Thin-Layer Chromatographic
Color reaction
Related substance | must conform, USP/FCC
must conform, USP/FCC
must conform, EP | conforms
conforms
conforms |
Related Substance Ratios
A300/A326
A350/A326
A370/A326 | ≤0.60, EP
≤0.54, EP
≤0.14, EP | 0.59
0.53
0.12 |
| Absorbance Ratio | [A325]/A325 >0.85, USP/FCC/ln house | 1.04 |
| Chroma | ≤3.0, In house | 2.0 |
| Retinol | ≤1.0%, EP/ln house | n.d. |
| All Trans-isomer Content | ≥95.0%, In house | 97.7% . |
| Acid Value | ≤2.0, EP | 0.94 |
| Peroxide Value | ≤10.0, EP | 3.6 |
| * Heavy Metals (as Pb) - | ≤10 mg/kg, Ch.P/CNS-GB5009.12 | <5 mg/kg |
| * Lead | ≤2 mg/kg, FCC/CNS-GB5009.12 | conforms |
| * Arsenic | ≤1 mg/kg, Ch.P/CNS-GB5009.11 | < 1 mg/kg |
| * Cadmium | ≤1 mg/kg, Ch.P/CNS-GB5009.15 | conforms, |
| * mercury | ≤1 mg/kg, Ch.P/CNS-GB5009.17 | conforms |
| Residual solvent (VICH Class 3) | ≤5,000 mg/kg, Ch.P/In house | 137.7 mg/kg |
Microbiological Tests
Total aerobic microbial count
Total mold & yeast count
Conforms
E. Coli
Salmonella
Staphylococcus Aureus | ≤1000 cfu/g, USP/EP
≤100 cfu/g, CNS-GB4789.15
≤30 mpn/100g, CNS-GB4789.3
n.d./25g, Ch.P/CNS-GB4789.38
n.d./25g, Ch.P/CNS-GB4789.4
n.d./25g, Ch.P/CNS-GB4789.10 | <10 cfu/g
conforms
conforms
conforms
conforms
conforms |
Assay
Expressed as International units
Expressed as equivelent amount of refnd | ≥1,700,000 IU/g, EP/FCC/ln house
≥510 mg/g, EP/USP/FCC/ln house | 1,747,000 lU/g
524 mg/g |
China
