Description

4-[4-(Dimethylamino)-1-(4-Fluorophenyl)-1-Buten-1-Yl]-3-(Hydroxymethyl)-Benzonitrile (Citalopram Olefinic Impurity) is a critical pharmaceutical reference standard and intermediate used in the synthesis and quality control of the antidepressant drug Citalopram. This compound is essential for analytical laboratories and API manufacturers to identify, quantify, and control process-related impurities, ensuring final drug product safety and regulatory compliance. It is primarily utilized by pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis in pharmacopeial testing (USP, EP, ICH guidelines).
• Active Pharmaceutical Ingredient (API) Development: Used as a key intermediate or impurity marker in the research and process optimization of Citalopram synthesis.
• Quality Control & Assurance: Critical for establishing impurity profiles, conducting stability studies, and ensuring batch-to-batch consistency of Citalopram API.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing impurity identification and characterization data.
• Method Development & Validation: Employed to develop and validate analytical methods for the specific detection and quantification of this olefinic impurity.
• Contract Research & Testing Laboratories: Used by third-party labs offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	4-[4-(Dimethylamino)-1-(4-Fluorophenyl)-1-Buten-1-Yl]-3-(Hydroxymethyl)-Benzonitrile (Citalopram Olefinic Impurity)
CAS No.	920282-75-3
Molecular Formula	C20H21FN2O
Molecular Weight	324.40 g/mol
Synonyms	Citalopram Impurity F (Olefin); Citalopram Related Compound F; Citalopram EP Impurity F; (E)-4-[4-(Dimethylamino)-1-(4-fluorophenyl)but-1-en-1-yl]-3-(hydroxymethyl)benzonitrile; 1-[4-(Dimethylamino)but-1-en-1-yl]-4-fluoro-3-(hydroxymethyl)benzonitrile; Citalopram Olefin; Citalopram Process Impurity
EINECS	Contact for details

Quality Control

Our Citalopram Olefinic Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets stringent standards for use as a pharmaceutical reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards. Our quality commitment aligns with ICH Q3A, Q3B, and relevant pharmacopeial guidelines for impurities.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.