Droxidopa Related Compounds & Impurities

Droxidopa is a synthetic amino acid prodrug converted to noradrenaline, used for neurogenic orthostatic hypotension in autonomic failure.

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 Droxidopa reference standards, pharmacopeial and non-pharmacopeial Droxidopa 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 Droxidopa-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

Droxidopa
Droxidopa Impurity 1
Droxidopa Impurity 18
Droxidopa Amine
Droxidopa Impurity 10
Droxidopa Racemic Standard
Droxidopa Erythro Isomer
Droxidopa Impurity 22
Droxidopa Metabolite Hydrate
(Z)-3-(benzo[d][1,3]dioxol-5-yl)-2-(1,3-dioxoisoindolin-2-yl)acrylic acid
(Z)-2-(2-(benzo[d][1,3]dioxol-5-yl)vinyl)isoindoline-1,3-dione
(Z)-3-(3,4-dihydroxyphenyl)-2-(1,3-dioxoisoindolin-2-yl)acrylic acid
(Z)-2-(3,4-dihydroxystyryl)isoindoline-1,3-dione
Droxidopa Impurity 6
(2R,3R)-2-amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid
2,3,8,9-tetrahydroxy-5,6,11,12-tetrahydro-5,11-epiminodibenzo[a,e][8]annulene-5-carboxylic acid
Droxidopa NNC Impurity
Droxidopa BBC Impurity
Droxidopa Impurity 25
Droxidopa carbamate
Droxidopa Enantiomer Impurity
Droxidopa Phthalimido Impurity
Droxidopa Impurity 30
Droxidopa Dimer Impurity 1
Droxidopa Dimer acid Impurity 2

Isotope Labelled Compounds

Droxidopa-D3 Sodium Salt
Droxidopa Trifluoroacetic Salt 13C7