Description

Duloxetine Impurity (α-Hydroxy) is a key process-related impurity and degradation product of the antidepressant drug Duloxetine hydrochloride. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Duloxetine API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification, qualification, and quantification of Duloxetine-related substances in Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., hydrolytic, oxidative, photolytic).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to establish impurity thresholds and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Duloxetine to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Duloxetine Impurity (α-Hydroxy)
CAS No.	940291-11-2
Molecular Formula	C18H19NOS
Molecular Weight	297.41 g/mol
Synonyms	(S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-ol; (S)-3-(Methylamino)-1-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-ol; Duloxetine Alcohol Impurity; Duloxetine Related Compound A (α-Hydroxy); LY248686 Alcohol Impurity; (S)-Duloxetine Alcohol
EINECS	Contact for details

Quality Control

Our Duloxetine Impurity (α-Hydroxy) is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitable for use as a pharmaceutical reference standard.

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 must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
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

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