Ampicillin Sodium

Ampicillin Sodium

CAS number: 69-52-3

Molecular formula: C16H18N3NaO4S

Molecular weight: 371.39

Chemical Structure:

Product Name	Ampicillin Sodium Non Sterile
Shelf Life	2 years
Pharmacopoeial Standard	CVP 2015, BP2009
Packing	25KGS/DRUM
TESTS	SPECIFICATION
Identification	The retention time of principal peak of the substance being examined is identical with that of ampicillin CRS.The infrared absorption speetram is concordant with that of ampicillin CRS.Yields the flame reaction of sodium salts.
Characters	A white or almost white crystalline power
Clarity of Solution	Solution is clear
Heavy metals	=20ppm
Granularity	100% through 120 mesh
Residual solvent	Acetone =0.5%
	Ethyl Acelate =0.5%
	Isopropyl Alcohol =0.5%
	Methylene Chloride =0.2%
	Methyl Isobutyl Ketone =0.5%
	Methyl Benzene =0.5%
	N-butanol =0.5%
Visible particles	Conforms
pH	8.0-10.0
Water content	=2.0%
Specific optical rotation	+258°-+287°
2-Ethylhexanoic acid	=0.8%
Related substance	Ampicillin dimmer =4.5%
Related substance	Other individual maximum impurity =2.0%
Insoluble particles	25um~600um
Insoluble particles	10um~6000um
Assay(%)	Not less than 85% (the dried)
RESULTS: The commodity meets CVP2015, BP2009

Product Name	Ampicillin Sodium Sterile
Shelf Life	2 years
Pharmacopoeial Standard	BP2009
Packing	25KGS/DRUM
TESTS IR, 2) Sodium test, Characters Clarity of Solution Related Substances Dimethylaniline Methylene Chloride Sterility Bacterial Endotoxins Heavy Metals pH Water Content Specific Optical Rotation 2-Ethylhexanoic Acid Assay	SPECIFICATION Precipitation test A white or almost white crystalline power Solution is clear Conforms =20ppm =0.2% Conforms =0.15 EU/mg =20ppm pH:8.0-10.0 =2.0% +258°-+287° =0.8% 91.0%-102%
CONCLUSION: CONFORM FULLY WITH THE STANDARD OF BP2009