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Specification

 USP 38

Items

Acceptance criteria

Results

Appearance

 White to off-white crystalline powder

 White crystalline powder

Solubility

It is slightly soluble in methanol, in ethanol (99.5), in acetonitrile, and practically insoluble in water.

 Conforms

Identification

 A. The IR spectrum should correspond to that obtained with RS

 Consistent with that obtained with RS

 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

 Consistent with that  obtained with Standard preparation

Loss on Drying

 ≤0.25%

 0.07%

Residue on Ignition

 ≤0.1%

 0.04%

Chloride

 180 ppm

180 ppm

Heavy Metals

 ≤0.001%

 ≤0.001%

Particle size

 90% less than 20um and 10% less than  10um

 Conforms

Related Compounds

 Impurity A ≤ 0.10%

 0.02%

 Impurity B ≤ 0.10%

 Not detected

 Impurity C ≤ 0.10%

 0.03%

 Any other individual impurity ≤ 0.10%

 See Note 1

 Total impurities ≤ 0.40%

 0.21%

Residual Solvents

 N, N-Dimethylacetamide ≤ 1090 ppm

 Conforms

 Chloroform ≤ 60 ppm

 25 ppm

 Methanol ≤ 3000ppm

 950 ppm

Assay by HPLC

98.0% ~ 102.0% (calculated on dried basis)

99.8%

Mirobiological Contarnination/g

A) Total aerobic microbial count

B) Total combined moulds & yeasts

C) Other specific microorganisms(E.Coli,Salmonella sp)

≤1000 cfu

≤1000 cfu

Absent

Conforms

Conforms

Conforms

Conclusion

  It complies with the requirement of USP38