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Amoxicillin trihydrate

CAS# 61336-70-7

Molecular Formula :  C16H25N3O8S   

Specification:  USP  powder or compacted

Packing: 25kg/fiber drum 

Application: Semi-synthetic antibiotic related to Penicillin. Antibacterial.


Technical Data Sheet  

Items Specification Results
Desciption White or almost white crystalline powder Conforms
Solubility Slightly soluble in water,hardly soluble in ethanol,does not dissolve in olis and fats,soluble in dilute acid , dilute alkali Conforms
Identification IR : the IR spectrum of sample should be concordant with the spectrum of working standard Conforms
TLC: the principal spot in the chromatogram obtained with the test solution should be similar in position,colour to the principal spot in the chromatogram obtained with reference solution. Conforms
Chemical test:should develop dark yellow colour Conforms
Appearance of solution
(in HCl/NH4OH)
Not more opalescent than reference suspension Ⅱ Conforms
PH 3.5-5.5 5.1
Specific optical rotation +290°~+315° +305°
Water 11.5%-14.5% 13.3%
Assay(anhydrous) 95.0-102.0% 100.0%
Related substances Any impurity :≤1.0% 0.1%
Related solvents N,N-Dimethylaniline:≤20ppm
Acetone:≤0.5%
methanol: ≤0.3%
----(not used in process)
----
0.01%
Sulfated ash ≤1.0% 0.035%
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