ampicillin
Test
Specification
Result
Result Judgement
CHARACTERS
IDENTIFICATION
TESTS
Appearance of solution
1 M hydrochloric acid
2M ammonia
Specific optical rotation
pH
Water
Related substances
N,N-Dimethylaniline
Sulphated ash
Assay
(Calculated with reference to the anhydrous substance)
A white crystalline powder
Complies
≤2#
≤2#
+280°+305°
3.55.5
12.0%15.0%
Impurity(individual)≤1.0%
≤20ppm
≤0.5%
96.0%100.5% of ampicillin
A white crystalline powder
Complies
Complies
Complies
+297°
4.34
13.63%
0.41%
Never used in the production
0.09%
99.3%
Complies
Complies
Complies
Complies
Complies
Complies
Complies
Complies
Complies
Complies
Complies