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Description |
Clear, colourless slightly greenish-yellow, viscous, oily liquid, EP/USP/FCC |
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Identification |
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Optical Rotation |
-0.01°~+0.01°EP |
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IR |
To conform, EP/USP/FCC |
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Color Reaction |
To conform, USP/FCC |
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Retention Time |
To /confirm/i, USP/FCC |
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Related Substances |
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Impurity A |
≤0.5%, EP |
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Impurity B |
≤1.5%, EP |
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Impurity C |
≤0.5%, EP |
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Impurities D and E |
≤0.1%, EP |
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Any other impurities |
≤0.25%, EP |
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Total Impurities |
≤2.5%, EP |
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Acidity |
≤1.0ml, USP/FCC |
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Residual Solvents |
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Isobutyl Acetate |
≤0.5% (in-house) |
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Heavy metals |
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Pb |
≤2mg/kg, FCC |
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Arsenic |
≤1mg/kg (in-house) |
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Copper |
≤25mg/kg (in-house) |
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Zinc |
≤25mg/kg (in-house) |
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Palladium |
≤5ppm (in-house) |
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Assay |
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Assay (1) |
96.5%~102.0%, EP |
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Assay (2) |
96.0%~102.0%, USP/FCC |
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Microbiological tests |
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Total Aerobic Microbial count |
≤1000cfu/g, EP/USP |
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Total Moulds and yeasts count |
≤100cfu/g, EP/USP |
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Escherichia Coli |
n.d./g, EP/USP |
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Pseudomonas Aeruginosa |
n.d./g, EP/USP |
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Staphylococus aureus |
n.d./g, EP/USP |
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Enterobacterial |
n.d./g, EP/USP |
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Salmonella |
n.d./g, EP/USP |
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