Pharmaceutical Grade 122111-03-9 Gemcitabine Hydrochloride

Gemcitabine Hydrochloride


Molecular formula: C9H12ClF2N3O4
Molecular Weight: 299.66
CAS No.: 122111-03-9
Other Name: 4-Amino-1-[3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1H-pyrimidin-2-one hydrochloride
Competitive price with high quality
CERTIFICATE OF ANALYSIS
 

Product Name	Gemcitabine Hydrochloride
Batch No.	2017060302	Date of Test	Jun. 03,2017
Quantity	10.6KGs	Date of Mfg.	Jun. 03,2017
Standard	EP8.3	Date of Report	Jun. 02,2018

 

ITEMS		SPECIFICATIONS	RESULTS
Appearance		White to off-white powder	Conforms
Solubility		Soluble in water, slightly soluble in methanol, practically insoluble in acetone	Conforms
Specific optical Rotation		+43º~+50º	+48.0º
Identification	A	Infrared absorption spectrophotometry (2.2.24) comparision Gemcitabine Hydrochloride CRS	Conforms
	B	It gives reaction (a) of chloride (2.3.1)	Conforms
Appearance of solution		Solution Sample in clear(2.2.1) and not more intensely	Conforms
pH		2.0~3.0	2.2
Related substances		Impurity A: ≤0.15% Impurity C: ≤ 0.2% Unspecified impurities:  ≤ 0.1% Total impurities: ≤ 0.4%	0.001% Not detected 0.03% 0.03%
Heavy metals		≤ 10ppm	Conforms
Sulphated ash		≤ 0.1%	0.03%
Residual solvents		Methanol: ≤ 0.3% Acetone: ≤ 0.5%	Not detected 0.1%
Assay		97.5%~101.5%	99.1%
Bacteria		< 50cfu/g	< 10cfu/g
Yeast and Mold		< 20cfu/g	< 10cfu/g
E. coli		No detected.	No detected
Conclusion		The above product complies with the standard of EP8.3.