Description

Droxidopa Impurity 4 is a specified impurity of the active pharmaceutical ingredient Droxidopa, a synthetic amino acid precursor used in the treatment of neurogenic orthostatic hypotension. This impurity is a critical reference standard for pharmaceutical manufacturers to ensure product quality, safety, and regulatory compliance during the development and production of Droxidopa. It is essential for analytical method validation, stability studies, and impurity profiling in pharmaceutical quality control laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Droxidopa Impurity 4 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods used in quality control.
• Stability Indicating Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of ICH stability protocols.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing impurity characterization data required for Drug Master Files (DMFs) and Common Technical Documents (CTDs).
• Quality Control & Batch Release: Serves as a system suitability standard and for setting specification limits in the routine QC testing of Droxidopa API.
• Research & Development: Used in synthetic route optimization and process chemistry to understand and minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Droxidopa Impurity 4
CAS No.	55382-14-4
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; L-DOPS Impurity; (-)-three-DOPS Impurity; Erythro-Droxidopa; Droxidopa Related Compound 4; L-three-Dihydroxyphenylserine; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Droxidopa Impurity 4 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of related substances and residual solvents, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing all test results and methods is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The compound is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

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

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