Ertapenem Related Compounds & Impurities

Ertapenem is a once-daily carbapenem antibiotic with broad Gram-positive and Gram-negative coverage but limited anti-pseudomonal activity, used for community-acquired infections.

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 Ertapenem reference standards, pharmacopeial and non-pharmacopeial Ertapenem 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 Ertapenem-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

Ertapenem
Ertapenem sodium
Ertapenem Impurity Pro-maba
Ertapenem Ring Open Impurity
Ertapenem Open Ring Trisodium Salt
(R)-Hydroxyprolinylaminobenzoic acid
Ertapenem Sulfoxide
Ertapenem Dimer Form D Impurity
Ertapenem Oxazinone Impurity
Ertapenem Dimer (Mixture of I & II)
Ertapenem Dimer III
Ertapenem Impurity 1 Trisodium Salt (Ring Open)
(S)-3-(pyrrolidine-2-carboxamido)benzoic acid compound with 2,2,2-trifluoroacetic acid
N-Nitroso Ertapenem
Ertapenem Impurity 3 Hydrochloride
Ertapenem N-Carbonyl Dimer Impurity
Ertapenem Dimer Impurity
Ertapenem Dimer Ester Impurity
Ertapenemic Acid
Ertapenem Dimer IV
Ertapenem Dimer VI
Ertapenem Impurity 12
Ertapenem Impurity 29
Ertapenem Impurity 6
Ertapenem Dimer V
Ertapenem Dimer (a+b)
Ertapenem Impurity 32
Ertapenem Impurity 33
Ertapenem Impurity 34
Ertapenem Impurity 35
Ertapenem Impurity 39
Ertapenem Impurity 40
Ertapenem Impurity 41
Ertapenem Disodium
Ertapenem Impurity 5
Ertapenem Dimer II
Ertapenem Dimer I
Ertapenem Impurity 7
Ertapenem Impurity 8
Ertapenem Impurity 9
Ertapenem Impurity 10
Ertapenem Impurity 11

Isotope Labelled Compounds

Ertapenem D4 sodium Salt
Ertapenem D4 Disodium Salt