Ceftriaxone Sodium

CAS number: 74578-69-1

Molecular formula: C18H16N8Na2O7S3

molecular weight: 598.5436

Chemical structure:

Product NamePHARMACEUTICAL ALLOPATHIC RAW MATERIAL FOR INDUSTRY Ceftriaxone Sodium Sterile USP 
Shelf life
3 years
TEST ITEMSSPECIFICATIONRESULT
Descriptionwhite to yellowish-organge crystlline powder.Almost white crystalline powder
Identification

By IRMeets the requirements.Complies
By HPLCMeets the requirements.Complies
Tests for sodiumIt gives reaction of sodiumPositive
Test

CrystallinityMeets the requirements.Complies
pH6.0~8.06.5
Impurity ADeacetylcetotaxime lactone≤0.5%Not Detected
Impurity B,C7-Aminocephalosporanic acid≤0.5%0.01%
Impurity DCeftriaxone triazine analog≤1.0%0.09%
Impurity ECeftriaxone benzathiazoly oxime≤0.2%Not Detected
Impurity FDeacyl ceftriaxone≤0.5%0.07%
Impurity GCeftriaxone 3-ene isomer≤0.3%Not Detected
Impurity HCeftriaxone E-isomer≤0.5%0.02%
Any individual≤0.2%0.04%
Unknown impurity

Total impurities≤2.5%0.3%
Water(By KF)8.0%~11.0%9.3%
Methanol≤0.3%Not Detected
≤0.5%Not Detected
≤0.041%Not Detected
≤0.5%Not Detected
≤0.06%Not Detected
≤0.5%Not Detected

Partieless≥10μg/mg:NMT 6000 part/g

660
Partieless≥25μg/mg:NMT 600 part/g
<0.20EU/mgComplies
It complies with the test for sterlityComplies
Informative0.54g/ml
Informative0.72g/ml
ASSAY

Ceftriaxone on anhydrous basis795μg/mg932μg/mg
Storage Condition Preserve in airtight,tamper-proof container;in a dry place at a temperature not exceeding 20℃.
RESULT: THE RESULT CONFORMS TO USP38、QS-CO11014(USP)-01.