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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
|
Total impurities ¡Ü1.0%
|
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Max unknown single impurity ¡Ü0.5%
|
|
Loss on drying
|
¡Ü0.5%
|
|
Melting Point
|
About 255¡æ
|
|
Residue on ignition
|
¡Ü0.1%
|
|
Heavy metal
|
¡Ü20ppm
|
|
Assay
|
98.0%~ 102.0%
|
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Residual Solvents
|
Shall meet the requirements of USP
|
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Particle Size
|
80% particle passed through 20¦Ìm
|
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Microbiological Contamination
|
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
|
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
|
