Darunavir Related Compounds & Impurities

Darunavir is a second-generation HIV-1 protease inhibitor with a 1000-fold binding affinity advantage over first-generation agents and a high barrier to resistance development, used as a cornerstone of modern combination antiretroviral 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 Darunavir reference standards, pharmacopeial and non-pharmacopeial Darunavir 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 Darunavir-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

Darunavir
Darunavir Ethanolate
Bis furanol carbonate
Hydroxy Darunavir
Darunavir Impurity A
Darunavir Impurity A Enantiomer
Darunavir Urea Impurity
Darunavir CBZ Furan Impurity
Darunavir Impurity 15
N`-Bis THF Darunavir
Darunavir Amine Dimer Impurity
Darunavir CBZ Urea Impurity
Darunavir CBZ Amino Impurity
D-(+)-Darunavir
2,5-dioxopyrrolidin-1yl[3S,3aS,6aR)-hexahydrofluoro[2,3-b]furan-3-yl-carbonate
Darunavir Impurity 7
Darunavir Impurity 47
Darunavir Impurity
3-amino-1-chloro-4-phenyl-2-Butanone
3-amino-1-chloro-4-phenylbutan-2-one
Darunavir Impurity (RR)
2-Epi-Darunavir
Darunavir Impurity 17
Darunavir EP Impurity D
N-((2S,3R)-4-(4-amino-N-isobutyl phenolsulfonate)-3-hydroxy-1-phenylbutan-2-yl)formamid
(1R,2S)-Darunavir
BIS THF HNS Derivative 1
BIS THF HNS Derivative 3
4-(acetylamino)-, methyl ester
Propan-2-yl 4-acetamidobenzenesulfonate
4-amino-N-(((4S,5R)-4-benzyl-2-oxooxazolidin-5-yl)methyl)-N-isobutylbenzenesulfonamide
Darunavir Isomer-4 Impurity
Darunavir Isomer-5 Impurity
Darunavir Impurity 9
Darunavir Impurity 8 (RR)
Darunavir Impurity 10
(1R,2S)-Darunavir
Darunavir Isomer-3 Impurity
Difurofuranyl Darunavir
BIS THF Nitro Derivative 1
Darunavir Impurity 24
Darunavir Impurity 25
tert-butyl((2S,3R)-3-hydroxy-4-(isobutylamino)-1-phenylbutan-2-yl)carbamate
Darunavir N-acetyl carbamate impurity
Darunavir Chlorohydrin Impurity
Darunavir propylene glycolate solvate
-((2S,3R)-4-(4-amino-N-isobutylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-yl)carbamic acid
methyl ((2S,3R)-4-(4-amino-N-isobutylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-yl)carbamate
Darunavir Diamino (2R,3R) Isomer
Darunavir Impurity 4
Darunavir Impurity 28
Ethyl -4-acetamidobenzenesulfonate
Darunavir Impurity 11
Darunavir Impurity 30
Darunavir Impurity 29
Darunavir Impurity 31
Darunavir Ethanolate Impurity C
Darunavir Ethanolate Impurity E
(1R,2R)-Darunavir
Darunavir Impurity 12
Darunavir Dimer Impurity
Darunavir Impurity 16
Darunavir Impurity 21
N-lactose Darunavir
(3S,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl(4-nitrophenyl)carbonate
(3R,3aR,6aS)-hexahydrofuro[2,3-b]furan-3-yl(4-nitrophenyl)carbonate
(3S,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl 4-nitrophenyl carbonate
Darunavir Impurity B
Darunavir Impurity C
Darunavir Impurity 14
Darunavir Impurity 53
Darunavir Impurity 20
Darunavir DNV-II Impurity 1
Darunavir Impurity 55
Darunavir Impurity 19
Darunavir Impurity 56
Darunavir Impurity 57
Darunavir Impurity 58
Darunavir Enantiomer
Darunavir Impurity 15

Isotope Labelled Compounds

Darunavir D9
[13C6]-Darunavir