Description

Citalopram Descyano Impurity Oxalate is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the synthesis and quality control of the antidepressant drug Citalopram, ensuring the final product's safety and efficacy. It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry for method development, validation, and regulatory compliance testing. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards and ensuring batch-to-batch consistency.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of descyano impurity in Citalopram Hydrobromide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring drug product safety per ICH Q3A/B thresholds.
• Stability Studies: Used as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Citalopram.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in optimizing synthetic routes by helping to identify and minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Citalopram Descyano Impurity Oxalate
CAS No.	390817-87-5
Molecular Formula	C21H23FN2O5
Molecular Weight	402.42 g/mol
Synonyms	1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile Oxalate; Descyano Citalopram Oxalate; Citalopram Des-Cyano Impurity Oxalate; Citalopram Impurity F Oxalate; Citalopram Related Compound F Oxalate; Lu 10-005-B Oxalate; 5-Cyano-1-(4-fluorophenyl)-1-(3-(N,N-dimethylamino)propyl)phthalane Oxalate
EINECS	Contact for details

Quality Control

Our Citalopram Descyano Impurity Oxalate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and control of residual solvents and moisture. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results and traceability. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container sealed when not in use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
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%
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.