CHARACTERS A white or almost A white particle
Crystalline particle Complies
IDENTIFICATION Complies Complies Complies
TESTS
Appearance of solution
0.5 M hydrochloric acid ≤ 2# 1# Complies
2M ammonia ≤ 2# 1# Complies
Specific optical rotation +290° - +315° +309° Complies
pH 3.5-5.5 4.64 Complies
Water 11.5%-14.5% 13.18 % Complies
Related substances Impurity(individual)≤ 1.0% 0.14% Complies
N, N-Dimethylaniline ≤ 20ppm Never used in the production Complies
Sulphated ash ≤ 1.0% 0.08% Complies
Assay
(calculated with reference 95.0%~102.0% of amoxillin 99.7% Complies
To the anhydrous substance)
Conclusion: Complies with BP2011 standard.
Shijiazhuang zhongshuo pharmaceutical group is the biggest active pharmaceutical group in the world. We have through the FDA certificate.
