Pharmaceutical Raw Materials

Ampicillin Trihydrate

CAS: 7177-48-2
Purity: 99%min
Appearance: A White Crystalline Powder
Package: 25kg drum
Product description: Application Antibiotic and Antimicrobial Agents
INQUIRY

Ampicillin Trihydrate

Product Name: Ampicillin trihydrate

CAS NO: 7177-48-2

Purity: 99%min

HS Code: 29411092.00

Appearance: A White Crystalline Powder

Solubility: Slight soluble in water, very slightly soluble in ethanol (96%), practically insoluble in fatty oils. It dissolves in dilute acids and dilute solutions of alkali hydroxide

Stability: Stable under recommended conditions of use

Application: Antibiotic and Antimicrobial Agents

Specification:

Item	Standard	Result
Character	White or almost white crystalline powder	A White crystalline powder
Identification	1.The IR spectrum obtained with the substance to be examined. corresponds with that obtained with reference standard	Confirms
Identification	2. should meet the requirement under water	Confirms
Appearance of solution	Not more opalescent than reference suspension II(1 mol/L HCI solution)
Appearance of solution	Not more opalescent than reference suspension II(2 mol/L ammonla)
pH	3.5~5.5	4.5
Specific optical rotation	+280°~+305°(Calculated on the anhydrous basis)	+299
Related Substance	Any impunity≦1.0%	0.15%
N.N-Dimethytaniline	≦20ppm(Not used in process)	Confirms
N.N-Dimethytaniline	≦20ppm(Not used in process)	Confirms
Water	12.0%-15.0%	13.6%
Sulphated Ash	≤0.5%	0.07%
Residual Solvent	Methylene chloride≦600ppm	173 ppm
Assay	It contains 96.0%-102.0% of ampicillin C16H19N3O4S calculated on the anhydrous basis	100.1%
Conclusion: The Results conform with EP9 and client request. Pharmacopoaia quality: Complies with the current editions of USP, EP&BP. Manufactured according to ICH Q7 GMP for APLs