Description

Droxidopa Impurity 8 is a specified impurity 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 essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Droxidopa drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Droxidopa API and formulations.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing of Droxidopa batches to ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings.
• Process Chemistry Research: Aids in the optimization of synthesis and purification processes to minimize this specific impurity.

Basic Information

Item	Details
Product Name	Droxidopa Impurity 8
CAS No.	29025-01-2
Molecular Formula	C9H11NO5
Molecular Weight	213.19 g/mol
Synonyms	L-DOPS Impurity 8; (2S,3R)-2-Amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid impurity; Droxidopa Related Compound 8; 3,4-Dihydroxyphenylserine Impurity; L-Threo-DOPS Impurity; Erythro-Droxidopa Impurity; DOPS Impurity C; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Droxidopa Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results. Our quality systems are designed to support compliance with cGMP and relevant ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and opened under controlled conditions to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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