Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Montelukast was launched as Singulair in Mexico and Finland for the management of mild to moderate asthma inadequately controlled by inhaled corticosteroids and short-acting beta2-agonists.
Montelukast is suitable for relieving symptoms caused by allergic rhinitis
Montelukast is used for a number of conditions including asthma, exercise induced bronchospasm, allergic rhinitis, primary dysmenorrhoea and urticaria.
Montelukast is mainly used as a complementary therapy in adults in addition to inhaled corticosteroids, if they alone do not bring the desired effect.
Montelukast is also used to prevent allergic reactions and asthma flare-ups during the administration of intravenous immunoglobulin.
Test Items | Specification | Results of Analysis |
Appearance | White or almost white crystalline powder | Positive |
Identificantion | Litmus paper turns blue from red | Conforms |
Melting Point | 184ºC~189ºC | 185.0ºC~188.8ºC |
Assay | 98.0~102.0% | 0.9995 |
PH | 8.0~10.0 | 9.25 |
Specific rotation | -65~-70° | -65.30° |
Loss on drying | ≤0.5% | 0.0002 |
Chloride | ≤100ppm | Pass |
Heavy metals | ≤10ppm | Pass |
Iron content | ≤10ppm | Pass |
Related substances(TLC) | ≤10ppm | Pass |
Residue on ignition | ≤0.1% | 0.0002 |
Conclusion | The specification comply with Enterprise standard | |