Ceftriaxone Sodium

CAS number:74578-69-1

Molecular formula:C18H16N8Na2O7S3

molecular weight:598.5436

Chemical structure:

Product Name PHARMACEUTICAL ALLOPATHIC RAW MATERIAL FOR INDUSTRY Ceftriaxone Sodium Sterile USP 
Shelf life
3 years
TEST ITEMS SPECIFICATION RESULT
Description white to yellowish-organge crystlline powder. Almost white crystalline powder
Identification

By IR Meets the requirements. Complies
By HPLC Meets the requirements. Complies
Tests for sodium It gives reaction of sodium Positive
Test

Crystallinity Meets the requirements. Complies
pH 6.0~8.0 6.5
Impurity A Deacetylcetotaxime lactone≤0.5% Not Detected
Impurity B,C 7-Aminocephalosporanic acid≤0.5% 0.01%
Impurity D Ceftriaxone triazine analog≤1.0% 0.09%
Impurity E Ceftriaxone benzathiazoly oxime≤0.2% Not Detected
Impurity F Deacyl ceftriaxone≤0.5% 0.07%
Impurity G Ceftriaxone 3-ene isomer≤0.3% Not Detected
Impurity H Ceftriaxone 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/mg Complies
It complies with the test for sterlity Complies
Informative 0.54g/ml
Informative 0.72g/ml
ASSAY

Ceftriaxone on anhydrous basis ≥795μg/mg 932μg/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.