Montelukast is used for a number of conditions including asthma, exercise induced bronchospasm, allergic rhinitis, primary dysmenorrhoea (i.e. dysmenorrhoea not associated with known causes; see dysmenorrhea causes), and urticaria.It is mainly used as a complementary therapy in adults in addition to inhaled corticosteroids, if they alone do not bring the desired effect. It is also used to prevent allergic reactions and asthma flare-ups during the administration of intravenous immunoglobulin.
Specification:
Item |
Specification |
Description |
White or off-white powder |
Assay |
≥99.0% |
Identification |
|
Chemistry |
Must conforms to standard |
Identification (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 |
pH |
9.0~10.5 |
Impurity |
Not more than 0.5% of any individual impurity is found, the sum of all impurities found is not more than 1.0% |
S-isomer |
NMT 1.0% |
OVI |
Must conforms to standard |
Heavy metals |
NMT 20ppm |
Loss on drying |
NMT 1.0% |
microbe |
|
Bacterium |
NMT 1000 cfu/g |
Mildew |
NMT 100 cfu/g |
Coliform |
NMT 0 cfu/g |
Packaging details:
Packaging details: |
5 kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
Shelf Life: |
5 years if sealed and store away from direct sun light. |