Description

Ent-Montelukast Sodium Salt is the enantiomer of the active pharmaceutical ingredient Montelukast Sodium. This high-purity compound is critical for pharmaceutical research and development, particularly in the study of stereoselective activity and the development of enantiomerically pure drug substances. It serves as a vital reference standard and starting material for scientists in the pharmaceutical and biotechnology sectors who require precise chemical tools for analytical method development, metabolic studies, and impurity profiling.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation (HPLC, LC-MS).
• Key starting material or intermediate in the research and synthesis of enantiomerically pure leukotriene receptor antagonists.
• Essential for stereochemical and pharmacological studies to understand the specific biological activity of the ent-enantiomer.
• Used in impurity identification and qualification during the quality control of Montelukast Sodium active pharmaceutical ingredient (API).
• Critical component in metabolic and pharmacokinetic research to differentiate the pathways of individual enantiomers.

Basic Information

Product Name	Ent-Montelukast Sodium Salt
CAS No.	190078-45-6
Molecular Formula	C35H35ClNNaO3S
Molecular Weight	608.17 g/mol
Synonyms	(-)-Montelukast Sodium; (R)-Montelukast Sodium; 1-(((1(R)-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic Acid Sodium Salt; ent-Montelukast Sodium; The Enantiomer of Montelukast Sodium; UNII-3Q6KYZ25KJ; SQ 31,636 (Enantiomer)
EINECS	Contact for details

Quality Control

Our Ent-Montelukast Sodium Salt is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral purity analysis, to ensure it meets the high standards required for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting identity, purity (by HPLC), and specific tests for related substances and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Chiral Purity (Chiral HPLC)	≥99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤0.5% Total impurities: ≤2.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.