Customization: | Available |
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Certification: | GMP, FDA, ISO |
Grade Standard: | Medicine Grade |
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Audited by an independent third-party inspection agency
Items | Standards | Results |
Characteristics | White to off-white,practically odourless,crystalline powder,or white to off-white solid | Complies |
Identification | By IR | Complies |
By HPLC | Complies | |
It responds to the tests for Sodium | Complies | |
Optical Rotation | -10°~-24° | -21° |
pH | 4.0~6.0 | 5.1 |
Water | ≤ 6.00% | 0.80% |
Relative Substance |
Tetrazolylacetic acida: ≤1.00% | 0.00% |
Tetrazolylacetamide acetalb: ≤1.00% | 0.30% | |
Cefazolin open-ring Lactonec,d or cefazolin 3-hydroxymethylc,e: ≤0.50% | ND | |
Methylthiadiazole thiolf: ≤1.00% | 0.30% | |
7-Aminocephalosporanic acidg: ≤1.00% | ND | |
Cefazolin 3-methyln analogh: ≤1.00% | ND | |
Cefazolin lactonel: ≤1.00% | 0.10% | |
Cefazolin acetoxy analogl: ≤1.00% | ND | |
Cefazolin deacylatedk: ≤1.00% | 0.00% | |
Cefazolin acid isomersl: ≤1.00% | 0.00% | |
Cefazolin epimerm: ≤1.00% | ND | |
Cefazolin pivaloyln: ≤1.00% | 0.00% | |
Any individual unspecified impurity: ≤0.10% | 0.08% | |
Total impurities: ≤3.50% | 0.80 | |
Bacterial Endotoxins | ≤0.15 USP EU/mg of cefazolin | Complies |
Sterility | Should be sterile | Complies |
Assay (HPLC basis on drying) |
89.1%~110.1% | 96.70% |
Reference Standard | USP38 Standard | |
Conclusion | The product complied to USP38 standard. | |
Storage | Preserve in tight,light-resistant containers in a cool place |