Ampicillin sodium sterile for injection Lyophilized API EP USP GMP factory price

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1 Kilogram	Negotiable

1 Kilogram

Negotiable

Ampicillin Ampicillin sodium Ampicillin sodium sterile

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Pls see below our information for Ampicillin Sodium

Product Name: Ampicillin Sodium Sterile

Cas: 69-52-3

Specification： EP, USP

Packing: 7kg/tin, 2tin/carton or 5kg/tin, 2tin/carton

Appearance: White Powder

Certificate: GMP Certificate

Product Name: Ampicillin Sodium Sterile

Cas: 69-52-3

Specification： EP, USP

Packing: 7kg/tin, 2tin/carton or 5kg/tin, 2tin/carton

Part COA of Ampicillin Sodium

ITEMS	SPECIFICATION	RESULTS
DESCRIPTION	WHITE OR ALMOST WHITE POWDER	WHITE POWDER
IDENTIFICATION	CONFORM	CONFORM
CLARITY OF SOLUTION	No more than #2	< 1
ABSORBANCE OF SOLUTION	430nm≤0.15	0.01
PH	8.0~10.0	8.9
SPECIFIC OPTICAL ROTATION	+258°~+287°	+272°
BIGGEST IMPURITY	≤ 2.0 %	0.7%
AMPICILLIN DIMER	≤ 4.5 %	3.0%
N,N-DIMETHYLANILINE	≤ 0.0020 %	NOT DETECTED
2-ETHYLHEXANOIC ACID	≤ 0.8 %	0.02%
METHYLENE CHLORIDE	≤ 0.2 %	0.03%
HEAVY METAL	≤ 0.0020 %	< 0.0020 %
WATER	≤ 2.0 %	1.0%
STERILITY	CONFORM	CONFORM
BACTERIAL ENDOTOXINS	<0.15IU/mg	CONFORM
PYROGEN FREE	CONFORM	CONFORM
VISIBLE FOREIGN MATTER	CONFORM	CONFORM
INSOLUBLE PARTICLES	≤ 2250grain/g (≥10 um)	400grain/g
	≤ 225 grain/g (≥25 um)	44grain/g
ASSAY(AS ANHYDROUS SUBSTANCE)	91.0~102%	93.6%
CONCLUSION: THE ABOVE RESULTS COMPLY WITH EP8