Description

Droxidopa Impurity 5 is a designated impurity of the pharmaceutical agent Droxidopa, a synthetic amino acid precursor used in the treatment of neurogenic orthostatic hypotension. This specific impurity is a critical reference standard in the pharmaceutical development and manufacturing process, essential for ensuring product safety, efficacy, and regulatory compliance. It is primarily required by analytical laboratories, quality control departments, and research institutions involved in the synthesis, purification, and validation of Droxidopa drug substances and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification, qualification, and quantification of Droxidopa Impurity 5 in active pharmaceutical ingredients (APIs) and drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Droxidopa.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity profiles and ensure batches meet stringent pharmacopeial (e.g., USP, EP) or internal specifications.
• Stability Studies: Acts as a marker to track impurity formation and degradation pathways during forced degradation and long-term stability studies of Droxidopa.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Used by chemists to study and optimize synthesis routes to minimize the formation of this specific impurity.

Basic Information

Product Name	Droxidopa Impurity 5
CAS No.	16322-99-9
Molecular Formula	C9H11NO5
Molecular Weight	213.19 g/mol
Synonyms	L-DOPS Impurity 5; (2S,3R)-2-Amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid impurity; 3,4-Dihydroxyphenylserine Impurity 5; Northerna Impurity; SM-5688 Impurity; (-)-Three-DOPS Related Compound 5; L-threo-DOPS Impurity 5; 3-Hydroxy-L-tyrosine Impurity
EINECS	Contact for details

Quality Control

Every batch of Droxidopa Impurity 5 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, assay, purity, and related substances. Our quality commitment aligns with the needs of cGMP-compliant pharmaceutical operations.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage under inert atmosphere, please contact us for specific recommendations.

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)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.