Description

(S)-Citalopram Fluorophenylmethanone Oxalate Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) citalopram by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments involved in the synthesis, purification, and quality assurance of chiral drug substances.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of a specific stereoisomeric impurity in citalopram drug substance and finished products.
• Method Development and Validation: Used as a critical standard in developing and validating analytical methods, such as HPLC, UPLC, or LC-MS, for impurity detection in compliance with ICH guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the levels of this specific impurity during API manufacturing and batch release testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and demonstrate comprehensive control of the drug substance.
• Stability Studies: Used to track the formation or increase of this impurity over time in drug product stability studies under various ICH conditions.
• Research and Development: Aids in process chemistry research to understand and minimize the formation of this impurity during the synthetic route optimization of citalopram.

Basic Information

Product Name	(S)-Citalopram Fluorophenylmethanone Oxalate Impurity
CAS No.	1217846-85-9
Molecular Formula	C21H21F2NO5
Molecular Weight	405.40 g/mol
Synonyms	(S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonyl fluoride oxalate; (S)-Citalopram Fluoroketone Oxalate; Citalopram Fluorophenylmethanone Impurity Oxalate Salt; (S)-Citalopram Fluoroketone Related Compound Oxalate; Citalopram EP Impurity F (Oxalate); Citalopram USP Related Compound (Oxalate Salt); 1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-5-[(fluorocarbonyl)-1,3-dihydro-2-benzofuranyl] methanone oxalate (S-isomer)
EINECS	Contact for details

Quality Control

Our pharmaceutical impurity standards are manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, GC, MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on assay, impurities, and residual solvents. Our quality standards align with ICH Q3A, Q3B, and relevant pharmacopoeial guidelines (USP, EP) for impurities in new drug substances and products.

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 dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
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.