Buy USP37 Standard Montelukast Sodium Powder Online for Asthma Treatment
What is Montelukast sodium?
Montelukast is a leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. Montelukast comes as a tablet, a chewable tablet, and granules to take by mouth.[4] Montelukast is usually taken once a day with or without food.
Montelukast is a CysLT1 antagonist; it blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene and results in less inflammation.
Montelukast sodium Basic Information
CAS No.: 151767-02-1
Formula: C35H35ClNNaO3S
Molecular Weight: 608.17
Synonyms: Singulair (TN); Singulair; MK 476;
Boiling Point: 750.5 ° C at 760 mmHg
Flash Point: 407.7 ° C
Appearance: White to off-white crystalline powder
Purity: 99.5%
Package: 1kg/aluminium foil bag or According to customer requirements for packaging
Montelukast sodium Certificate Of Analysis
| Product name |
montelukast sodium |
| CAS No. |
151767-02-1 |
Outer Packing |
Drum |
| Production date |
Jan.2017 |
Shelf life |
Dec.2019 |
| Standard adopted |
USP37 |
| Items of analysis |
Specification |
Results |
| Description |
white to almost white,hygroscopic powder |
almost white |
| solubility |
freely soluble in water and methylene chloride,freely soluble in alcohol |
complies |
| identification |
|
|
| A.By IR |
The infrared spectrum of sample should be concordant with that of montelukast sodium working standard |
complies |
| B.By HPLC |
the retention time of the major peak of sample preparation matches with the peak due to faster eluting component of system suitability preparation as directed in S-Enantiomeric by HPLC |
complies |
| C.By Sodium test |
a dense white precipitate is formed |
complies |
| water content |
NMT 4.0% w/w |
0.97% |
| heavy metal |
NMT 10 ppm |
complies |
| palladium content |
NMT 10 ppm |
complies |
| Related substances(By HPLC) |
|
|
| Sulfoxide impurity |
NMT 0.2% |
0.01% |
| methyl ketone impurity |
NMT 0.15% |
0.06% |
| michael aduct 1&2 impurity |
NMT 0.15% |
0.05% |
| Cis-isomer impurity |
NMT 0.15% |
0.04% |
| methyl styrene impurity |
NMT 0.3% |
0.21% |
| any unspecified impurity |
NMT 0.10% |
0.02% |
| total impurities |
NMT 0.6% |
0.38% |
| Enantiomeric purity S-enantiomer |
NMT 0.2% |
ND |
| Assay(BY HPLC)(On anhydrous basis) |
98.0-102.0% w/w |
100.16% |
| residual solvents |
|
|
| methanol |
NMT 3000 ppm |
329 ppm |
| acetonitrile |
NMT 410 ppm |
ND |
| methylene chloride |
NMT 600 ppm |
ND |
| n-hexane |
NMT 290 ppm |
ND |
| ethyl acetate |
NMT 5000 ppm |
ND |
| tetrahydrofuran |
NMT 720 ppm |
ND |
| n-heptane |
NMT 5000 ppm |
ND |
| toluene |
NMT 890 ppm |
ND |
| dimethylformamide |
NMT 880 ppm |
ND |
| benzene |
NMT 2 ppm |
ND |
| Conclusion |
Qualified |
Montelukast sodium Medical Uses
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.[6] 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.
Montelukast is administered as montelukast sodium, with 5.2 mg of montelukast sodium being equivalent to 5 mg of montelukast.
