Description

Droxidopa Impurity 6 is a specified impurity and degradation product of the active pharmaceutical ingredient Droxidopa, a synthetic amino acid precursor used in the treatment of neurogenic orthostatic hypotension. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Droxidopa drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Droxidopa API and drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data on impurity characterization for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Droxidopa to minimize the formation of this specific impurity.

Basic Information

Product Name	Droxidopa Impurity 6
CAS No.	90044-46-5
Molecular Formula	C9H11NO5
Molecular Weight	213.19 g/mol
Synonyms	(2S,3R)-2-Amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid; L-three-3,4-Dihydroxyphenylserine impurity; DOPS Impurity; L-DOPS Impurity 6; Droxidopa Related Compound 6; (-)-three-DOPS Impurity; Erythro-3-(3,4-dihydroxyphenyl)-L-serine impurity
EINECS	Contact for details

Quality Control

Our Droxidopa Impurity 6 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and heavy metals. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures material of the highest consistency and reliability for your critical analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15°C and 25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere or in a desiccator for long-term storage to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.