Eliglustat Related Compounds & Impurities

Eliglustat is an oral glucosylceramide synthase inhibitor used as substrate reduction therapy for type 1 Gaucher disease in CYP2D6 extensive metabolisers.

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 Eliglustat reference standards, pharmacopeial and non-pharmacopeial Eliglustat 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 Eliglustat-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

Eliglustat
Eliglustat Tartrate
Eliglustat Impurity 7
(1R,2R)-2-Amino-1-(2,3-dihydrobenzo[b][1,4]dioxin-6-yl)-3-(pyrrolidin-1-yl)propan-1-ol
Eliglustat enantiomer
(S)-(2-hydroxy-1-phenylethyl)glycine
Eliglustat Phenyl Amino Alcohol Impurity
Eliglustat Acetamide Amino Alcohol
Eliglustat N-Acetyl Impurity
Caprylic acid N-Sccinimidyl Ester
Eliglustat N-oxide
(1R,2S) Eliglustat Impurity
(1S,2R) Eliglustat Impurity
N-((1RS,2SR)-1-(2,3-dihydrobenzo(b)(1,4)dioxin-6-yl)-1-hydroxy-3-(pyrrolidin-1-yl)propan-2-yl)octanamide
Eliglustat O-octonyl Dimer
2-Amino-1-(2,3-dihydrobenzo[b][1,4]dioxin-6-yl)ethan-1-one hydrochloride
N-(1-(2,3-Dihydrobenzo[b][1,4]dioxin-6-yl)-1-oxo-3-(pyrrolidin-1-yl)propan-2-yl)octanamide oxalate
N-Nitroso Eliglustat
Eliglustat Nitroso Impurity 1
Eliglustat Nitroso Impurity 2
Eliglustat Nitroso Impurity 3
Eliglustat Nitroso Impurity 4
Eliglustat Impurity 6
Eliglustat Impurity 1
Eliglustat Hexa Analogue
Eliglustat Impurity 2
Eliglustat Lactose Adduct 1
Eliglustat Lactose Adduct 2
Eliglustat Impurity 3
Eliglustat Impurity 4
Eliglustat Impurity 5
Eliglustat Impurity 8
Eliglustat Impurity 9
Eliglustat Impurity 10
Eliglustat Impurity 11
Eliglustat Impurity 12

Metabolites

Eliglustat Metabolite 24(Racemic Mixture)
Eliglustat Metabolite 5
7-Keto metabolite
2-Phenyl Ethanol Impurity

Isotope Labelled Compounds

Eliglustat D4
Eliglustat-D15 Tartrate