Gabapentin Related Compounds & Impurities

Gabapentin is a GABA analogue that binds the alpha-2-delta subunit of voltage-gated calcium channels, used for neuropathic pain, postherpetic neuralgia and as adjunctive epilepsy therapy.

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 Gabapentin reference standards, pharmacopeial and non-pharmacopeial Gabapentin 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 Gabapentin-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

Gabapentin
Gabapentin EP Impurity A
Gabapentin EP Impurity E
Gabapentin EP Impurity B
Gabapentin EP Impurity D
Gabapentin EP Impurity D
2-{[(3S,4S,5R)-2,3,4,5-tetrahydroxytetrahydro-2H-pyran-2-yl]methyl}-2-azaspiro[4,5]decan-3-one
1,1-Cyclohexanediacetic acid mono amide
1,1-Cyclohexanediacetic acid
1,1-Cyclohexanediacetic acid sodium salt
2,4-dioxo-3-azaspiro[5.5]undecane-1,5-dicarbonitrile
Gabapentin dicyano Impurity
Gabapentin EP Impurity G Hydrochloride
Gabapentin EP Impurity G
Gabapentin Enacarbil
Gabapentin Acid Impurity
Gabapentin Allyl Impurity
Gabapentin Cyclic Impurity
Gabapentin EP Impurity-E
Gabapentine Impurity 37
Gabapentin lactose Adduct
Gabapentine Impurity 26
Gabapentine Impurity 3
Gabapentine Impurity 5
1-((((1-(2-(1-(isobutyryloxy)ethoxy)-2-oxoethyl)cyclohexyl)methyl)carbamoyl)oxy)ethyl isobutyrate
Gabapentine Impurity 7
1,1`-(octylazanediyl)bis(propan-2-ol)
2,2`-(decylazanediyl)diethanol
2-(2-(decylamino)ethoxy)ethanol
Gabapentine Impurity 35
methyl 2-cyano-2-cyclohexylideneacetate
ethyl 2-(1-cyanocyclohexyl)acetate
Gabapentine Impurity 3
Gabapentine Impurity 4
2-Nitroso-2-azaspiro[4,5]decan-3-one
Gabapentin Methyl ester
Gabapentin Di-Lactom Impurity
Gabapentine Impurity 36
Gabapentine Impurity 8
Dibuthylformazide
Gabapentine Impurity 17
Gabapentine Impurity 18
Cyclohexanemethanamine
Gabapentine Impurity 22
Gabapentine Impurity 25
propan-2-imine
1,1-Dimethoxybutane
Gabapentine Impurity 15
Gabapentine Impurity 29
Gabapentine Impurity 30
Gabapentine Impurity 31
Gabapentine Impurity 34
Gabapentin Form III
Gabapentin Dilactam Impurity
Gabapentin Formyl Impurity
Gabapentine Impurity 5
2-(1-((2-(1-hydroxycyclohexyl)acetamido)methyl)cyclohexyl)acetic acid
Gabapentine Impurity 43
Gabapentin Lactom Impurity
Gabapentine Impurity 45
Gabapentine Impurity 44
Gabapentine Lactose Adduct 1
Gabapentin Impurity 9
Gabapentin Ethyl Ester Hydrochloride
Gabapentin Methyl Ester Hydrochloride
Gabapentine Impurity 51
Gabapentine Impurity 49
Gabapentine Impurity 50
Gabapentine Impurity 52
Gabapentine Impurity 53
1,1-Cyclohexane Diacetic Monoamide
Gabapentine Impurity 56
Gabapentine Impurity 54
Gabapentine Impurity 57
Gabapentine Impurity 58
Cyclohex-3-enone
Gabapentine Impurity 61
Gabapentine Impurity 62
Gabapentine Impurity 60
2-(Cyclohexanecarbonyloxy)acetic acid
Gabapentine Impurity 2
Gabapentine Impurity 66
Gabapentine Impurity 67
Gabapentine Impurity 9
Gabapentine Impurity 10
Gabapentine Impurity 12
Gabapentine Impurity 13
Gabapentine Impurity 14
Gabapentine Impurity 11
Gabapentine Impurity 20
Gabapentine Impurity 21
Gabapentine Impurity 23
Gabapentine Impurity 24
Gabapentin Impurity 1
N-Nitroso Gabapentin EP Impurity A

Isotope Labelled Compounds

Gabapentin D6 Hydrochloride
Gabapentin D4