Amoxicillin Trihydrate CAS 61336-70-7
Items |
Company standard |
Results |
Appearance |
White ,pracitically odorless, crystalline powder |
White ,pracitically odorless, crystalline powder |
Identification |
The IR spectrum obtained with the correspond with that obtained with USP Amoxicillin RS The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay. |
Conforms
Conforms |
Crystallinity |
Show birefringence and extinction positions |
Conforms |
pH |
3.5-6.0 |
5.0 |
Water |
11.5%-14.5% |
12.8% |
Dimethylaniline |
≤20ppm |
Not applicable |
Organic impurities Impurity Ia Impurity Db Impurity Dc Impurity Ad Impurity Gg Impurity Eh Impurity Mj Impurity Ci Impurity Ei Impurity Jm Impurity Ln Any unspecified individual impurity Total imputities |
≤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%
|
Not detected Not detected Not detected Not detected Not detected Not detected Not detected Not detected Not detected 0.04% Not detected 0.03% 0.11%
|
Assay
|
900-1050ug/mg C16H19N3O5S(calculated on the anhydrous basis) |
994ug/mg |
Conclusion |
The results conform with USP |
Note: Dimethylaniline is bot used in the manufacturing process of this product and is not detectable in final products.It complies with USP