Product name：Amoxicillin trihydrate

Expiry Date：4 years

Items

Specifications

Results

Description

A white crystalline powder

A white crystalline powder

Identification

The IR Spectrum obtained with the substance to be examined should correspond with that obtained with USP amoxicillin RS.

Conforms

Crystallinity

Show birefringence and extinction positions

Conforms

Ph

3.5-6.0

4.6

Water

11.5%-14.5%

13.0%

N,N-Dimethylaniline

≤20ppm

Conforms

Not used in process

Organic impurities

Impurity I

Impurity D1

Impurity D2

Impurity A

Impurity G

Impurity E1

Impurity M

Impurity C

Impurity E2

Impurity J

Impurity L

Any unspecified individual impurity

Total impurities

≤1.0%

≤1.0%

≤1.0%

≤0.5%

≤1.0%

≤1.0%

≤1.0%

≤1.0%

≤1.0%

≤1.0%

≤1.0%

≤1.0%

≤5.0%

0.07%

Undetectable

Undetectable

Undetectable

0.24%

Undetectable

Undetectable

Undetectable

Undetectable

0.13%

Undetectable

0.01%

0.58%

Assay

It contains 900~1050ug/mg of amoxicillin C16H19N3O5S calculated on the anhydrous basis

982ug/mg

Residual solvents

dichloromethane

≤600ppm

432ppm

Acetone

≤5000ppm

69ppm

Triethylamine

≤300ppm

61ppm

Toluene

≤890ppm

343ppm

Pivalic acid

≤1000ppm

719ppm

Conclusion

The product conforms to USP and Enterprise stabdard