Item
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Standard
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Appearance
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White to pale yellow powder
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Identification
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IR: The sample spectrum must match with the standard spectrum.
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HPLC: The retention time of the principle peak of the standard time must match with the retention time of the principle time of the sample.
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Related substances
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Total impurities ¡Ü1.0%
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Max unknown single impurity ¡Ü0.5%
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Loss on drying
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¡Ü0.5%
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Melting Point
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About 255¡æ
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Residue on ignition
|
¡Ü0.1%
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Heavy metal
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¡Ü20ppm
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Assay
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98.0%~ 102.0%
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Residual Solvents
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Shall meet the requirements of USP
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Particle Size
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80% particle passed through 20¦Ìm
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Microbiological Contamination
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Total aerobic microbial count ¡Ü103 cfu/g
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Total combined Moulds and Yeasts ¡Ü102 cfu/g
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Specified micro organisms
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Escherichia Coli Absent/g
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Pseudomonas aeruginosa Absent/g
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staphylococcus aureus Absent/g
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Salmonella sp. Absent/10g
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