Powder: | Yes |
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Customized: | Non-Customized |
Certification: | GMP, ISO 9001, USP, BP |
Suitable for: | Elderly, Children, Adult |
State: | Solid |
Purity: | 916ug/Mg |
Customization: |
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Product: | CEFTRIAXONE SODIUM STERILE | ||
Manufacturing Date: | August 01, 2018 | ||
Expiry Date: | July 31, 2021 | ||
Batch No.: | 1808401302 | ||
TEST | REFERENCE | RESULTS | |
Description | • White to yellowish-orange crystalline powder. | Conforms | |
Solubility | Freely soluble in water, sparingly soluble in methanol, very slightly soluble in alcohol. | Conforms | |
Identification |
|
Conforms Conforms Conforms |
|
Crystallinity | Particles should show birefringence (interference colors) and extinction positions | Confbnns | |
pH | 6.0~8.0 | 6.8 | |
Water | 8.0%~11.0% | 9.2% | |
Bacterial endotoxins | ≤0.20 EU/mg | Conforms | |
Sterility | Meets the requirements (membrane filtration method) |
Conforms | |
Assay | Not less than 795pg of Ceftriaxone (C18H18N8O7S3) per mg (on the anhydrous basis) |
916ug/mg | |
Related substances | Deacetylcefotaxime lactone(Impurity B RRT:0.20) ≤ 0.5% 7-AminocephaIosporanic acid(RRT:0.34) ≤ 0.5% Ceftriaxone triazine analog(Impurity C RRT:0.62) ≤ 1.0% Ceftriaxone benzothiazolyloxime(Impurity D RRT:0.72) ≤ 0.2% Deacyl ceftriaxone(Impurity E RRT: 0.78) ≤ 0.5% Ceftriaxone 3-ene isomer(RRT:1.3) ≤ 0.3% Ceftriaxone E-isomer(Impurity A RRT: 1.4) ≤ 0.5% Any individual unspecified impurity ≤ 0.2% Total impurities ≤ 2.5% |
Not detected Not detected 0.08% Not detected Not detected Not detected 0.01% 0.04% 0.21% |
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Constituted solution (Completeness and clarity of solution) | The material should dissolve completely, leave no visible residue as undissolved matter. The solution should be as clear as water | Conforms | |
Particulate matters | Visual: The solution after reconsitution is free from particles of foreign matters/black particles that can be observed on visual inspection. | Conforms | |
Not less than 10um Particles, ≤6000/g | 36 |
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Not less man 25um Particles, ≤600/g | 3 | ||
Tapped density | Informative 0.79g/ml |
0.79g/ml |
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