Varieties: | Other |
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Component: | Chemical Synthetic Drugs |
Type: | Other |
Pharmacodynamic Influential Factors: | Other |
Storage Method: | Prevent Exceeding Quality Guarantee Period |
Veterinary Reg. No.: | Other |
Customization: |
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Items | Specification | Results | Methods |
Description | Yellow-orange crystalline powder | Orange crystalline powder | |
Melting point | 48°C~52-C | 50.0X:-50.5.C | USP (741) |
Solubility | Soluble in ether,trichloromethane | ||
and acetone;very slightly soluble in | |||
dehydrated alcohol; practically | Conform | ||
insoluble in water | |||
Identification | |||
IR | Sample spectrum consistent with the | USP (197K> | |
spectrum for USP Reference | Conform | ||
Standard | |||
Color reaction | A blue color appears | Conform | |
Sieve | 100% pass 80 mesh | ||
90% pass 100 mesh | Conform | USP (786) | |
Tapped Density | 0.40g/ml -0.60g/ml | 0.48g/ml | USP (616) I |
Water (KF) | ≤0.20% | 0.03% | USP (921) IC |
Residue on ignition | ≤0.10% | 0.08% | USP(281) |
Heavy metals | ≤10ppm | <10 ppm | USP (231) II |
Lead (Pb) | ≤0.5ppm | <0.5ppm | USP (2232) |
Mercury (Hg) | ≤0.1ppm | <0.1ppm | |
Cadmium (Cd) | ≤0.5ppm | <0.5ppm | |
Arsenic(As) | ≤1.0ppm | <1.0ppm | |
Chromatographic Purity | , | USP (621) | |
Coenzymes Q7,Q8,Q9,Q11 | ≤ 1.0% | 0.66% | |
and related impurities | |||
Ubidecarenone (2Z)-isomer |
≤0.5% | 0.22% | |
and related impurities | |||
Total impurities | Total 1& 2: ≤1.5% | 0.88% | |
Residual Solvents | USP (467) | ||
Methanol | ≤3000ppm | 5ppm | |
n-Hexane | ≤290ppm | 3ppm | |
Ethanol | ≤5000ppm | 9ppm | |
Isopropyl ether | ≤300ppm | Not detected | |
Assay (on the anhydrous basis) |
98.0-101.0% | 99.4% | USP621) |
Microbial limit test | |||
TotalAerobic Microbial | ≤ 1000cfu/g | <10cfu/g | USP2021) |
Count | |||
Yeast & Mold Count | ≤50cfu/g | <10cfu/g | USP (2021) |
E. coli ^ | Absent/l0g | Not detected | USP (2022) |
Salmonella | Absent /25g | Not detected | USP (2022) |
Bile-tolerantgram negative | ≤ 10MPN/g | < 10MPN/g | USP (2021) |
bacteria | |||
Staphylococcus aureus | Absent /25g | Not detected | USP (2022) |
Pseudomonas aeruginosa | Absent /10g | Not detected | USP (62) |
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