Description

Droxidopa Impurity 23 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Droxidopa. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Droxidopa drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products in Droxidopa formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Used in pharmaceutical R&D to understand the synthesis pathway, degradation routes, and metabolism of Droxidopa.

Basic Information

Item	Details
Product Name	Droxidopa Impurity 23
CAS No.	1432483-91-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Droxidopa Related Compound 23; Droxidopa Impurity K; L-DOPS Impurity 23; (2S,3R)-2-Amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid impurity; Noradrenaline precursor impurity; 1432483-91-4; Droxidopa EP Impurity K; Droxidopa USP Impurity
EINECS	Contact for details

Quality Control

Our Droxidopa Impurity 23 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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