Ensifentrine Related Compounds & Impurities

Ensifentrine is a dual phosphodiesterase 3 and 4 inhibitor with combined bronchodilator and anti-inflammatory activity, developed as an inhaled therapy for COPD.

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 Ensifentrine reference standards, pharmacopeial and non-pharmacopeial Ensifentrine 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 Ensifentrine-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

Ensifentrine
(E/Z)-Ensifentrine
10-Des-Methyl Ensifentrine
9-Des-Methyl Ensifentrine
Ensifentrine Des-Ethyl Urea Impurity
Ensifentrine Isoindole-1,3-dione Impurity
Ensifentrine Impurity 3
Ensifentrine Impurity 2
Ensifentrine Impurity 4
Ensifentrine amine impurity
Ensifentrine Dimer Impurity
Ensifentrine Hydrochloride impurity
Ensifentrine Impurity 6
Ensifentrine Impurity 1
Ensifentrine Impurity 7
Ensifentrine Hydroxy Impurity
Ensifentrine Impurity 5
Ensifentrine Impurity 8
(E)-Ensifentrine
Ensifentrine Biuret Impurity
Ensifentrine Impurity 9
Ensifentrine Impurity 10
Ensifentrine Impurity 11
Ensifentrine Impurity 12
Ensifentrine Impurity 13

Isotope Labelled Compounds

Ensifentrine D6