Product Name: AMOXACILLIN TRIHYDRATE

Characteristics

White or almost white crystalline powder

Conform

Specific optical rotation

+290 º-+315 º

+309º

Identification

Conform

Conform

Water

11.5-14.5%

13.1%

Ph

3.5-5.5

4.9

Appearance of solution

1.0g,0.5mol/L HCL 10ml≤2#

1#

Appearance of solution

1.0g,0.5mol/L NH4OH    10ml≤2#

1#

Related substance

Individual impurity≤1.0%

0.08%

N,N-Dimethylaniline

≤20ppm

Never used in the    production

Sulphated ash

≤1.0%

0.11%

Assay

95.0-102.0%(HPLC)
     Calculated on the    anhydrous basis

101.8%