Montelukast EP Impurity I

Name: Montelukast EP Impurity I
Brand: Vaqora Chemicals
SKU: VQ-023175

About Montelukast EP Impurity I

Listed under CAS 2045402-27-3, Montelukast EP Impurity I is a pharmacopeial impurity of Montelukast available from Vaqora Chemicals. With the molecular formula C35H36ClNO4S, it has a molar mass of 602.2 g/mol. Alternative names: a-Hydroxy Montelukast and Montelukast - Impurity I.

The product is provided as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. Handle it with standard laboratory precautions and appropriate personal protective equipment.

Pharmaceutical QC and development laboratories use this impurity standard of Montelukast to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. It is used across pharmaceutical manufacturing and academic and industrial research.

Vaqora Chemicals supplies Montelukast EP Impurity I in 10 mg, 25 mg, 50 mg and 100 mg packs, each shipped with a Certificate of Analysis (COA), and exports worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Montelukast

View every impurity, metabolite and intermediate we list for Montelukast.

Montelukast impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Montelukast EP Impurity I
Catalogue No.	VQ-023175
CAS Number	2045402-27-3
IUPAC name	2-[1-[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]-2-hydroxyacetic acid
Molecular formula	C₃₅H₃₆ClNO₄S
Molecular weight	602.2 g/mol
Exact mass	601.2054
Grade	Reference Standard
HSN code	38229090
InChIKey	QFJAHHNMKTWTGZ-DZAPPIOQSA-N
SMILES	CC(C)(C1=CC=CC=C1CC[C@H](C2=CC=CC(=C2)/C=C/C3=NC4=C(C=CC(=C4)Cl)C=C3)SCC5(CC5)C(C(=O)O)O)O
PubChem CID	70702423

Physical properties
Physical form	Solid
LogP (XLogP3)	7.2
H-bond donors / acceptors	3 / 6
TPSA	116 Å²
Synonyms	a-Hydroxy Montelukast, Montelukast - Impurity I, alpha hydroxy montelukast, alpha-Hydroxy Montelukast, Montelukast metabolite M7, A-Hydroxy Montelukast

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Montelukast EP Impurity I?

The CAS Registry Number of Montelukast EP Impurity I is 2045402-27-3. It is also known as a-Hydroxy Montelukast, Montelukast - Impurity I, alpha hydroxy montelukast.

What is the molecular formula and molecular weight of Montelukast EP Impurity I?

Montelukast EP Impurity I has the molecular formula C35H36ClNO4S and a molecular weight of 602.2 g/mol. Its IUPAC name is 2-[1-[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]-2-hydroxyacetic acid.

What is Montelukast EP Impurity I used for?

Montelukast EP Impurity I is supplied as a characterised reference material related to Montelukast. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Montelukast EP Impurity I can I order?

We supply Montelukast EP Impurity I in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Montelukast EP Impurity I?

Yes. Every lot of Montelukast EP Impurity I is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Montelukast EP Impurity I be shipped internationally?

Yes. We export Montelukast EP Impurity I worldwide by air and sea freight or express courier, on EXW, FOB, CIF, CFR or DAP Incoterms, with full export documentation.