Description

Venlafaxine Impurity1 CAS NO 627810-07-5 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antidepressant drug Venlafaxine by accurately identifying and quantifying process-related impurities. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Venlafaxine Impurity1 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Used in developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, for impurity profiling of Venlafaxine.
• Quality Control and Batch Release: Employed as a system suitability standard and for preparing calibration curves to ensure the purity and safety of commercial Venlafaxine batches against established pharmacopeial limits.
• Stability Studies: Utilized in forced degradation and long-term stability studies to monitor the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate comprehensive impurity control strategies for Venlafaxine.
• Research and Development: Aids in process chemistry research to understand and minimize the formation of this impurity during the synthesis of Venlafaxine.

Basic Information

Product Name	Venlafaxine Impurity1
CAS No.	627810-07-5
Molecular Formula	C17H27NO2
Molecular Weight	277.40 g/mol
Synonyms	1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol; O-Desmethylvenlafaxine Impurity; Venlafaxine Related Compound 1; N-Desmethylvenlafaxine Impurity; Cyclohexanol, 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-; UNII-9K1I7C3M2P; 627810-07-5
EINECS	Contact for details

Quality Control

Every batch of Venlafaxine Impurity1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile 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, cool place. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed and stored in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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