Lenalidomide Related Compounds & Impurities

Lenalidomide is a thalidomide analogue immunomodulatory drug with direct antitumour and immune-enhancing effects, used for multiple myeloma, MDS and mantle cell lymphoma.

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 Lenalidomide reference standards, pharmacopeial and non-pharmacopeial Lenalidomide 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 Lenalidomide-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

Lenalidomide
Lenalidomide Impurity B
Lenalidomide N-Formyl Impurity
Lenalidomide N-Oxide Impurity
N-Methyl analogue of Lenalidomide
Lenalidomide Impurity 15
Lenalidomide Impurity 11
3-amino piperdine-2,6-dion Hydrochloride
Lenalidomide Impurity 5
Lenalidomide Impurity 3
2-(4-Amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)pentanedioic acid
L-Glutamine tert-Butyl Ester Hydrochloride
Lenalidomide Impurity 1
Lenalidomide Impurity E
5-Hydroxy Lenalidomide
Nitrobenzoate Lenalidomide Impurity
Lenalidomide Impurity 2
Lenalidomide Crystal form A
Lenalidomide Impurity 10
Lenalidomide N-Hydroxy Impurity
Lenalidomide Impurity 9
Lenalidomide 5-Hydroxy Impurity
Lenalidomide Impurity 3
2-(4-amino-1-oxoisoindolin-2-yl)pentanediamide
Lenalidomide Impurity 12
Lenalidomide Impurity 13
Lenalidomide Impurity 14
Lenolidomide N-Hydroxy Impurity
Lenalidomide N-Formyl Impurity
4-Nitro Lenalidomide
Methyl 2-(2-Bromomethyl)-6-nitrobenzoate
Lenalidomide Impurity 16
Lenalidomide Impurity 17
L-Glutamic Anhydride Hydrochloride
Lenalidomide Impurity 21
4-amino-a-(3-amino-3-oxopropyl)1,3-dihydro-1-oxo-2H-Isoindole-2-aceticacidmethylester
Lenalidomide Impurity 19
5-Amino-4-(4-nitro-1-oxoisoindolin-2-yl)-5-oxopentanoic Acid
N-Acetyl Lenalidomide
Lenalidomide Impurity 23
methyl 2-hydroxymethyl-3-nitrobenzoate
Lenalidomide Lactosamine Adduct
Lenalidomide Impurity 30
Methyl-2-methyl-4-nitro-benzoate
2-methyl-5-nitro-benzoic acid methyl ester
2-methyl-6-nitro benzoic acid methyl ester
4-methyl-3-nitrobenzoic acid methyl ester
3-methyl-2-nitro benzoic acid methyl ester
4-Nitrophthalide
Lenalidomide Impurity 7
Methyl5-amino-2-(4-amino-1-oxoisoindolin-2-yl)-5-oxopentanoate
Glutamic Anhydride
Lenalidomide Hemihydrate
2-Methyl-5-nitrobenzoic acid
Methyl 4-methyl-3-nitrobenzoate
Lenalidomide Impurity 34
N-Hydroxy Lenalidomide
Lenalidomide Nitroso Impurity
Lenalidomide (Form H1)
Lenalidomide Impurity 5
2H-Isoindole-2-butanoicacid,4-amino-gamma-(aminocarbonyl)-1,3-dihydro-1-oxo-,(gammaS)
Lenalidomide Impurity D
Lenalidomide Impurity 49
Propanamide,3-amino-N-[2-(2,6-dioxo-3-piperidinyl)-2,3-dihydro-1-oxo-1H-isoindol-4-yl]-,Hydrochloride
Lenalidomide Impurity 50
Lenalidomide Form-B
Methyl 3-methyl-4-nitrobenzoate
Lenalidomide Impurity 58
Lenalidomide Impurity 6
Lenalidomide Dimethyl sulphoxide
Lenalidomide Impurity 4
Lenalidomide Impurity 8
Lenalidomide Impurity 18

Isotope Labelled Compounds

rac-Lenalidomide-13C5
Lenalidomide-d5