Items | Specifications |
Appearance | Yellow-orange crystalline powder |
Solubility | Soluble in ether; trichloromethane and acetone; very slightly soluble in dehydrated alcohol; practically insoluble in water |
Particle Size | 100% pass 80 mesh |
Identification | IR: Sample spetrum are consistent with the reference standard spectrums |
Retention time: The retention time of the principal peak in the chromatogram obtained with the test solution is smilar to that of the principal peak in the chromatogram obtained with reference solution | |
Color reation:A blue color appears | |
Melting point | 48.0℃-52.0℃ |
Related Substances | Any impurity<0.5% |
Total impurities≤1.0% | |
Impurity F | ≤0.5% |
Water (KF) | ≤0.2% |
Sulphate Ash | ≤0.1% |
Heavy Metals | ≤10ppm |
Lead(Pb) | ≤0.5ppm |
Mercury(Hg) | ≤0.1ppm |
Cadmium(Cd) | ≤0.5ppm |
Arsenic(As) | ≤1.0ppm |
Assay | 97%~103% |
Residual Solvents | Methanol≤3000ppm |
n-Hexane≤290ppm | |
Ethanol≤5000ppm | |
Isopropyl ether≤300ppm | |
Total Aerobic Micobial Count | ≤1000cfu/g |
Yeast & Mold | ≤50cfu/g |
E.coli | Absence/10g |
Samonella spp. | Absence/25g |
Bile-tolerant gram negative bacteria | ≤10MPN/g |
Staphylococeus aureus | Absence/25g |
Items | Specifications |
Appearance | Yellow or orange crystalline powder |
Identification | IR: Consistent with USP standard |
HPLC: Consistent with the spectrogram | |
Melting point | 48.0℃-52.0℃ |
Water | ≤0.2% |
Residue on ignition | ≤0.1% |
Particle size | ≥90% pass 80 mesh |
Total Heavy metal | ≤10ppm |
Arsenic | ≤1.5ppm |
Lead | ≤0.5ppm |
Mercury (Total) | ≤1.5ppm |
Methylmercury (As Hg) | ≤0.2ppm |
Cadmium | ≤0.5ppm |
Impurities | Test 1: Q7, Q8, Q9, Q11 Related impurities: ≤1.0% |
Test 2: (2Z)-isomer and related impurities: ≤1.0% | |
Test 1 & Test 2: Total impurities: ≤1.5% | |
N-hexane | ≤290ppm |
Ethyl Alcohol | ≤5000ppm |
Methanol | ≤2000ppm |
Isoproply ehter | ≤800ppm |
Total aerobic bacteria | ≤1000cfu/g |
Yeast &Mold | ≤50cfu/g |
E.Coli | Negative/10g |
Salmonella | Negative/25g |
S.aureus | Negative/25g |
Content(%) | 98.0%~101.0% |