Description

Citalopram impurity 9/Citalopram EP Impurity C Oxalate Salt/3-Oxo Citalopram Oxalate Salt/Citalopram Related Compound C Oxalate Salt/3-(3-Dimethylaminopropyl)-3-(4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone oxalate is a high-purity reference standard critical for analytical and regulatory compliance in pharmaceutical development and manufacturing. This compound serves as a certified impurity standard essential for the quality control and validation of Citalopram Hydrobromide, a widely prescribed antidepressant. It is primarily required by pharmaceutical R&D laboratories, quality assurance (QA) departments, and contract research organizations (CROs) to ensure drug safety, efficacy, and adherence to strict pharmacopoeial monographs.

Application

• Pharmaceutical Reference Standard: Used as a primary standard for the identification, qualification, and quantification of Citalopram EP Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: Essential for developing and validating robust analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, in compliance with ICH guidelines.
• Stability Studies: Employed to monitor impurity profiles and degradation pathways of Citalopram under various stress conditions to establish shelf-life and storage recommendations.
• Regulatory Submissions: Provides critical data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Quality Control Testing: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays for batch release.
• Pharmacopoeial Compliance: Directly supports testing to meet the specifications outlined in the European Pharmacopoeia (EP) and other international compendia for Citalopram and related substances.

Basic Information

Product Name	Citalopram Impurity 9 (Citalopram EP Impurity C Oxalate Salt)
CAS No.	1440961-11-4
Molecular Formula	C24H25FN2O7
Molecular Weight	472.47 g/mol
Synonyms	Citalopram Impurity C; Citalopram EP Impurity C; Citalopram Related Compound C; 3-Oxo Citalopram Oxalate Salt; 3-(3-Dimethylaminopropyl)-3-(4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone oxalate; 1(3H)-Isobenzofuranone, 6-cyano-3-(3-(dimethylamino)propyl)-3-(4-fluorophenyl)-, oxalate (1:1); Citalopram Oxidative Impurity
EINECS	Contact for details

Quality Control

Every batch of our Citalopram Impurity 9 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization to ensure identity, purity, and consistency. We provide full supporting documentation, including a detailed Certificate of Analysis (COA) with batch-specific data from techniques such as HPLC, NMR, and mass spectrometry. Our standards are suitable for use in methods requiring compliance with ICH Q3B(R2) guidelines and relevant pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

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%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5%; Total impurities ≤ 2.0%

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