Montelukast sodium: leukotriene receptor antagonist.
Montelukast sodium testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Montelukast sodium: 2D structure drawn from the PubChem record (CID 23663996).
151767-02-1
C35H35ClNNaO3S
608.17 g/mol
Leukotriene receptor antagonist
Identity: Montelukast sodium
IUPAC name: sodium 2-[1-[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetate
Method for the $250 identity, purity and quantity test: HPLC-UV purity and assay, LC-MS identity, against a reference standard, with results in 3 to 5 business days.
The USP monograph covers identity by infrared spectroscopy, a sodium test and enantiomeric purity, assay by HPLC, organic impurities by HPLC and the enantiomer by chiral HPLC, plus water content. Full testing to the USP Montelukast Sodium monograph is available and quoted.
Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.
| Add-on test | Price |
|---|---|
| Identity and impurities | |
| FTIR identity | $90 |
| CHNS elemental analysis (carbon, hydrogen, nitrogen, sulfur) | $125 |
| Chiral purity (where a chiral method exists; new methods quoted) | $250 |
| Water, solvents and salt form | |
| Water content by Karl Fischer | $60 |
| Residual solvents | $150 |
| Counterions: chloride, acetate and TFA | $70 |
| Assay | |
| Assay, % w/w (with raw powder purity; $250 together) | +$50 |
| Metals and conformity | |
| Heavy metals: arsenic, cadmium, chromium, mercury and lead | $150 |
| Conformity: purity and quantity on more units from the same lot | $100 per extra unit |
| Microbiology (injectables) | |
| Endotoxin | $210 |
| Sterility or bioburden | $150 |
| Container closure integrity (CCI) | $50 |
| Screening | |
| Fentanyl screen | $50 |
10% off for 10 or more samples.
Need something else? Other tests are available on request.
Purity and quantity is $250 per sample (1 unit) and raw powder purity is $200 for 50 mg, with results in 3 to 5 business days. Send the material sealed and labeled, with the label claim and the form it contains.
No. The $250 test covers identity, purity and quantity by HPLC-UV for purity and assay and LC-MS for identity. Full testing to the USP Montelukast Sodium monograph is available and quoted.
Yes. Light converts montelukast to its cis isomer, and air oxidizes it to a sulfoxide, both of which show up as impurity peaks in the HPLC purity method. Keep samples in the original packaging and away from light.
No. Montelukast is a single enantiomer, and its mirror-image form has the same mass and retention time on a standard column. The monograph checks it by chiral HPLC, which is quoted separately.
Powder, film-coated tablets, chewable tablets and oral granules. Each is extracted and reported as percent of the label claim, which is normally stated as montelukast base.
https://pubchem.ncbi.nlm.nih.gov/compound/23663996
Identity facts from the USP monograph header for this compound.
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