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PHR1603

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Montelukast Sodium

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Montelukast sodium
Empirical Formula (Hill Notation):
C35H35ClNO3S·Na
CAS Number:
151767-02-1
Molecular Weight:
608.17
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0001434
traceable to USP 1446859

API family

montelukast

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

InChI

1S/C35H36ClNO3S.Na/c1-34(2,40)30-9-4-3-7-25(30)13-17-32(41-23-35(18-19-35)22-33(38)39)27-8-5-6-24(20-27)10-15-29-16-12-26-11-14-28(36)21-31(26)37-29;/h3-12,14-16,20-21,32,40H,13,17-19,22-23H2,1-2H3,(H,38,39);/q;+1/p-1/b15-10+;/t32-;/m1./s1

InChI key

LBFBRXGCXUHRJY-HKHDRNBDSA-M

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General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Montelukast Sodium is an orally administered leukotriene receptor antagonist drug that acts by inhibiting the cysteinyl leukotriene (CysLT1) receptor. It is effective against leukotrienes responsible for bronchoconstriction and inflammation of the airways leading to asthma problems.

Application

Montelukast Sodium may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by chromatography and spectrophotometric techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB3617 in the slot below. This is an example certificate only and may not be the lot that you receive.

related product

Product No.
Description
Pricing

Y0001433

Montelukast racemate, European Pharmacopoeia (EP) Reference Standard

Y0001435

Montelukast for peak identification, European Pharmacopoeia (EP) Reference Standard

Y0001436

Montelukast dicyclohexylamine, European Pharmacopoeia (EP) Reference Standard

Y0001434

Montelukast sodium, European Pharmacopoeia (EP) Reference Standard

1446859

Montelukast sodium, United States Pharmacopeia (USP) Reference Standard

1446848

Montelukast racemate, United States Pharmacopeia (USP) Reference Standard

1446815

Montelukast dicyclohexylamine, United States Pharmacopeia (USP) Reference Standard

1446837

Montelukast for peak identification, United States Pharmacopeia (USP) Reference Standard

BP1147

Montelukast dicyclohexylamine, British Pharmacopoeia (BP) Reference Standard

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Spectrophotometric method for quantitative determination of montelukast in bulk, pharmaceutical formulations and human serum
Arayne MS, et al.
Journal of Analytical Chemistry, 64(7), 690-695 (2009)
HPTLC determination of montelukast sodium in bulk drug and in pharmaceutical preparations
Sane R, et al.
J. Planar Chromatogr., 17(1), 75-78 (2004)
Santa Mandal et al.
Inhalation toxicology, 32(7), 299-310 (2020-07-01)
To explore the therapeutic role of a single dose combination of montelukast (MON) and dexamethasone (DXM) through intra-peritoneal route against paraquat (PQ)-intoxicated experimental Wistar rats. In vivo the survival rate was investigated following the administration of both MON and DXM
Montelukast Sodium
USP42-NF37
United States Pharmacopeia/National Formulary, 37(2), 2974-2974 (2018)
Sheng-Hua Wu et al.
Pediatrics international : official journal of the Japan Pediatric Society, 56(3), 315-322 (2013-12-05)
Previous studies suggested that leukotrienes (LT) were involved in the pathogenesis of Henoch-Schönlein purpura (HSP). This study investigated the efficacy of an add-on therapy with montelukast in the treatment of HSP. In this four-center, double-blind, placebo-controlled, parallel paired comparative study
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