- E-mail : info@unihealthcarepharm.org
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. |
