Apremilast Related Compounds & Impurities

Apremilast is a selective PDE4 inhibitor that elevates intracellular cAMP to dampen pro-inflammatory cytokine production, used orally for psoriasis and psoriatic arthritis.

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 Apremilast reference standards, pharmacopeial and non-pharmacopeial Apremilast 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 Apremilast-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

Apremilast
Apremilast Impurity 10
Apremilast EP Impurity B
Apremilast EP Impurity D
Apremilast EP Impurity E
Apremilast EP Impurity H
Apremilast O-Desmethyl Impurity
Apremilast Degradation impurity -1
Apremilast 1-Acetamido Benzoic Acid Imurity
Apremilast Impurity 28
Apremilast EP Impurity F
(S)-1-(3-Ethoxy-4-Methoxyphenyl)-2-(Methylsulfonyl)ethylamine
Apremilast Impurity 1
N-(2-(1-(3,4-dimethoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide
1-(4-Ethoxy-3-methoxyphenyl)-2-(methylsulfonyl)ethanamine
Apremilast Impurity 2
Apremilast Des Acetyl Impurity
Apremilast R-Isomer
Apremilast 2-Acetamido Benzoic Acid Impurity
Apremilast Acetamido Sulfone Impurity
3-(Acetylamino)-6-[[[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]amino]carbonyl]-benzoic acid
N-Desacetyl-N-formyl Apremilast
Apremilast Hydrolysis Impurity
Apremilast Impurity 7
Apremilast Impurity 16
(R)-2-amino-6-((1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)carbamoyl)benzoic acid
O4-Desmethyl O3-Desethyl Apremilast
Desoxo Apremilast
N-(p-Toluenesulfonyl)-L-phenylalanine
Des-acetyl Apremilast
Racemate Apremilast
Apremilast Impurity 17
Apremilast 2-Acetamido Benzoic Acid Imurity
Apremilast Impurity 3
Apremilast 3-Acetamido Benzoic Acid Imurity
Apremilast Impurity 9
Apremilast Related Compound E
Apremilast Impurity 13
Apremilast Impurity 6
4-Hydroxy-Apremilast    
Apremilast Impurity 5
Desacetyl Apremilast
Apremilast Dimer
Apremilast Cyclized Dimer
Apremilast Impurity 22
Apremilast Impurity 25
N-Deacetyl Apremilast
Apremilast Impurity 20
Apremilast Impurity 26
Apremilast Impurity 21
(S)-5-amino-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)isoindoline-1,3-dione
Aprepitant M2 Metabolite (1S,2S,3R)-Isomer Hydrochloride
Aprepitant Impurity 7 Hydrochloride
N-Nitroso Apremilast
Apremilast Impurity 12
Apremilast Impurity 31
Apremilast Impurity 32
Apremilast Impurity 18
Apremilast Impurity 33
Apremilast Impurity 37
Apremilast Impurity 39
Apremilast Nitroso Impurity 1
Apremilast Impurity 29
Apremilast Impurity 23
Apremilast Impurity 8
2-(1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-4-nitroisoindoline-1,3-dione
Aprepitant (S,S,S)-Isomer Hydrochloride
Apremilast Form B
Apremilast Impurity 46
Apremilast Impurity 47
Apremilast Impurity 48
Apremilast Impurity 49
Apremilast Impurity 50
Apremilast Impurity 51
Apremilast Impurity 52
Apremilast Impurity 77
Apremilast Impurity 24
Apremilast Impurity 45
Apremilast Dimethoxy Analog
Apremilast Diethoxy Analog
Apremilast Impurity 11
Apremilast Impurity 4
Apremilast Impurity 14

Metabolites

O-Desmethyl Apremilast Glucuronide Sodium Salt

Isotope Labelled Compounds

Apremilast-D5
(S)-Apremilast D5
O-Desmethyl Apremilast Glucuronide