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Specification
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USP 38
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Items
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Acceptance criteria
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Results
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Appearance
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White to off-white crystalline powder
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White crystalline powder
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Solubility
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It is slightly soluble in methanol, in ethanol (99.5), in acetonitrile, and practically insoluble in water.
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Conforms
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Identification
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A. The IR spectrum should correspond to that obtained with RS
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Consistent with that obtained with RS
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B. The retention time of the major peak in the chromatogram of the Assay preparation should correspond to that in the chromatogram of the RS, as obtained in the Assay
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Consistent with that obtained with Standard preparation
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Loss on Drying
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≤0.25%
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0.07%
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Residue on Ignition
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≤0.1%
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0.04%
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Chloride
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180 ppm
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180 ppm
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Heavy Metals
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≤0.001%
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≤0.001%
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Particle size
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90% less than 20um and 10% less than 10um
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Conforms
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Related Compounds
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Impurity A ≤ 0.10%
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0.02%
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Impurity B ≤ 0.10%
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Not detected
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Impurity C ≤ 0.10%
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0.03%
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Any other individual impurity ≤ 0.10%
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See Note 1
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Total impurities ≤ 0.40%
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0.21%
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Residual Solvents
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N, N-Dimethylacetamide ≤ 1090 ppm
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Conforms
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Chloroform ≤ 60 ppm
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25 ppm
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Methanol ≤ 3000ppm
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950 ppm
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Assay by HPLC
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98.0% ~ 102.0% (calculated on dried basis)
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99.8%
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Mirobiological Contarnination/g
A) Total aerobic microbial count
B) Total combined moulds & yeasts
C) Other specific microorganisms(E.Coli,Salmonella sp)
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≤1000 cfu
≤1000 cfu
Absent
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Conforms
Conforms
Conforms
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Conclusion
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It complies with the requirement of USP38
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