Ceftriaxone Sodium

Details

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.