Montelukast Sodium Related Compounds & Impurities

Montelukast Sodium is the sodium salt of the CysLT1 leukotriene receptor antagonist, used for asthma prophylaxis and allergic rhinitis.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Montelukast Sodium reference standards, pharmacopeial and non-pharmacopeial Montelukast Sodium impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Montelukast Sodium-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Montelukast Sodium
Montelukast Acid
Montelukast Mercapto Acid Impurity
Montelukast (3S)-Hydroxy Propanol
Montelukast 3-Oxo Benzoate
Montelukast EP Impurity C
Montelukast (3R)-Hydroxy Benzoate
Montelukast EP Impurity F
Montelukast EP Impurity B
Montelukast Disulfide Impurity
Montelukast EP Impurity G
Montelukast Racemate
Montelukast Dicyclohexylamine
Montelukast Dicyclohexylamine Salt
Montelukast Sulfone
Montelukast Lactone
Montelukast Ether Impurity
Montelukast Dihydro Impurity (Sodium Salt)
Montelukast Dihydro Impurity
Montelukast EP Impurity H
Montelukast Bis-Sulfide
Montelukast Sodium EP Impurity A
Montelukast S-Isomer
Montelukast EP Impurity I
Montelukast Acid Impurity Disodium Salt
Montelukast Chloro alcohol Impurity
Montelukast Nitrile Impurity 1
Montelukast racemate (racemic mixture of Montelukast Dicyclohexylamine)
2-Methoxyphenylacetic Acid
Montelukast 1,2-Diol
Montelukast (3S)-Hydroxy Methylketone
Montelukast Ketone impurity
7-Chloro-2-methylquinoline
(S,E)-1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propan-1-ol
Montelukast Amide
Montelukast Methyl Ether
Montelukast Dicarboxylic Acid impurity (Mixture of Diastereomers)
Montelukast(3R)-Hydroxy Propanol
Montelukast EP Impurity E
Montelukast EP Impurity D
Montelukast Dicyclohexylamine
Montelukast Dehydro Impurity
Montelukast R-Sulfoxide
Montelukast Dehydro Impurity
(R,E)-2-(3-(((1-(carboxymethyl)cyclopropyl)methyl)thio)-3-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)propyl)benzoic acid
Montelukast (3RS)-Hydroxy Propanol
Montelukast Impurity 3
Montelukast Impurity 7
((E))-2-(3-(3-(2-(7-Chloro-2-quinolinyl)ethyl)phenyl)-3-hydroxypropyl)-benzoic acid methyl ester
Montelukast Disulfide Dimethyl Ester
Montelukast Acid Methyl Ester Impurity
Montelukast Impurity 14
1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]prop-2-en-1-ol
Montelukast + Montelukast EP Impurity A
Montelukast KSM-II Lactone Impurity
Montelukast Sulphoxide Impurity
Montelukast EP Impurity I Sodium Salt (Mixture of Diastereomers)
Methyl2-(3-{3-[2-(7-chloroquinolin-2-yl)vinyl]phenyl}-3-oxopropyl)benzoate
1-(Mercaptomethyl)cyclopropyl acetamide
Montelukast Impurity 19
1,1-Cyclopropanedimethanol cyclic sulfite
Montelukast Impurity 15
2,2`-(Cyclopropane-1,1-diyl)diacetic acid
Montelukast Impurity 9
Montelukast Impurity 21
Montelukast Impurity 22
Montelukast Bis-Sulfide
Montelukast Dimer Impurity
Montelukast Impurity 1
Montelukast Impurity 11
Montelukast Impurity 12
Montelukast Impurity 17
Montelukast Impurity 18
Montelukast Impurity 23
Montelukast Impurity 8
Montelukast Racemate Dicyclohexylamine
Montelukast Impurity 4
Montelukast S-Sulfoxide
Montelukast Thioglucolate Analog
Montelukast Impurity 10
Montelukast Ketocarbinol Impurity
Montelukast Methoxymethoxy Impurity
Montelukast Sulfoxide (Mixture of Diastereomers)
Montelukast Impurity 2
cis-Montelukast
Montelukast Impurity 5
Montelukast Impurity 6
Montelukast Acid Impurity

Metabolites

Montelukast Acyl-b-D-glucuronide
Montelukast (3S)-Hydroxy Methoxymethoxy Impurity
Montelukast (R)-Hydroxy Metabolite
Montelukast (S)-Hydroxy Metabolite

Isotope Labelled Compounds

Montelukast-D6 Sodium Salt
Montelukast D6