Azelaic acid Related Compounds & Impurities

Azelaic Acid is a naturally occurring dicarboxylic acid with antibacterial and anti-inflammatory properties, formulated topically for acne vulgaris and rosacea.

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 Azelaic acid reference standards, pharmacopeial and non-pharmacopeial Azelaic acid 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 Azelaic acid-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

Azelaic Acid
Azelaic anhydride
Pimelic acid
Suberic acid
Sebacic Acid
Suberic anhydride
Undecanedioic Acid
8-Methoxycarbonyloctanoic Acid
2-Nonenedioic Acid
Propylene glycol ester of Azelaic acid Impurity
9-dodecoxy-9-oxononanoic acid
2(E)-Nonenedioic Acid
2-Nonenoic Acid
3-Hydroxynonanoic Acid
9-Oxo-Nonanoic acid
Ethyl Ricinoleate
Azelaic Acid Impurity 1
Azelaic Acid Impurity 2
Azelaic Acid Impurity 3
Azelaic Acid Impurity 4

Metabolites

Heptane-1,1,7,7-Tetracarboxilic Acid
Heptane-1,1,7-Tricarboxylic Acid
Azelaic Acid Monoethyl Ester

Isotope Labelled Compounds

Azelaic acid-D14
Pimelic Acid-d4