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TESTS | SPECIFICATIONS | RESULTS | CONCLUSION |
[Description]
[Identification]
[Crystallinity] PH Water Sterility Bacterial Endotoxins Particulate matter
Acetone Assay | White to yellowish-orange crystalline powder (1) Infrared Absorption (2) The retention time of the major peak in the chromatogram of the assay corresponds to that exhibited in that of standard preparation (3) It responds to the tests for sodium Positive 6.0 ~ 8.0 8.0% ~ 11.0% Meets the specifications <0.20 USP EU/mg ceftriaxone ≥10um ≤2000pc/g ≥25um ≤200pc/g ≤5000ppm Ceftriaxone≥795 ug/mg (C18H18N8)7S3, on dry basis) | An almost white crystalline powder conforms conforms
conforms
conforms 7.1 9.6% Conforms Conforms 78pc/g 0pc/g 40ppm 918ug/mg | Conforms
Conforms Conforms
Conforms
Conforms Conforms Conforms Conforms Conforms Conforms Conforms Conforms Conforms
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Conclusion: It complies with USP32 and Enterprise Standard