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PHR1603

Montelukast Sodium

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Montelukast sodium

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About This Item

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

300

grade

certified reference material, pharmaceutical secondary standard

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

SMILES string

[Na+].S([C@H](CCc5c(cccc5)C(O)(C)C)c2cc(ccc2)\C=C\c3nc4c(cc3)ccc(c4)Cl)CC1(CC1)CC(=O)[O-]

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

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 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.
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.

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Storage Class

11 - Combustible Solids

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)
Montelukast Sodium
USP42-NF37
United States Pharmacopeia/National Formulary, 37(2), 2974-2974 (2018)
HPTLC determination of montelukast sodium in bulk drug and in pharmaceutical preparations
Sane R, et al.
J. Planar Chromatogr., 17(1), 75-78 (2004)
View All Related Papers

Global Trade Item Number

SKUGTIN
PHR1603-1G04061835238019