151767-02-1 Montelukast sodium Montelukast Sodium Amorphous
Production Name: Montelukast Sodium
Item |
Limit |
|
Identification |
||
physical chemistry Identification |
must conforms to standard. |
|
HPLC |
The retention time of test sample major peak complies to reference standard. |
|
Infrared Absorption |
must complies to reference standard. |
|
Sodium Identification |
the solution so obtained responds to the tests for sodium. |
|
Examination |
||
pH |
9.0~10.5 |
|
Impurity |
not more than 0.1% of any individual impurity is found the sum of all impurities found is not more than 0.5%. |
|
S-Isomer |
≤1.0% |
|
OVI |
must conforms to standard. |
|
Loss on Drying |
≤1.0% |
|
Heavy Metals |
≤20ppm. |
|
Assay |
calculated on the dried basis,not less than 99.0%. |
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