Product: | CEFTRIAXONE SODIUM STERILE | ||
Manufacturing Date: | August 01, 2023 | ||
Expiry Date: | July 31, 2023 | ||
Batch No.: | 1808401302 | ||
TEST | REFERENCE | RESULTS | |
Description | • W h ite 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
(C 18 H 18 N 8 O 7 S 3 ) per mg (on the anhydrous basis) |
916 u g/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% |
|
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 reco n sitution is free from particles of foreign matters/black particles that can be observed on visual inspection. | Conforms | |
Not less than 10 u m Particles, ≤ 6000/g |
36
|
||
Not less man 25um Particles, ≤ 600/g | 3 | ||
Tapped density |
Informative
0.79g/ m l |
0.79g/ml
|