Impurity reference standards
Montelukast impurities & reference standards
Characterised Montelukast impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
70reference materials
2isotope-labelled
COAHPLC · NMR · MS on request
Parent API: Montelukast
158966-92-8 · C35H36ClNO3S
FAQs — Montelukast impurities
Which Montelukast impurities do you supply?
We list 70 Montelukast-related reference materials, including process impurities, degradation products, stable-isotope-labelled standards and related compounds. Each is supplied with a COA, and characterisation data (HPLC, 1H-NMR, MS, IR) can be provided on request.
What are Montelukast impurity standards used for?
They are used for analytical method development and validation, impurity identification and quantification, forced-degradation and stability studies, and to support ANDA, DMF and other regulatory submissions under ICH Q3A/Q3B (and ICH M7 for mutagenic impurities).
Can you synthesise a Montelukast impurity that is not listed?
Yes. Our custom synthesis service can prepare and characterise unlisted impurities, metabolites and labelled analogues from milligram to gram scale. Share the structure or name and required quantity for a quotation.
Request Montelukast impurity standards
We reply within one business day with price, pack options, lead time and documentation.