Description

Citalopram Related Compound B CAS NO 1332724-03-4 is a high-purity chemical reference standard, specifically identified as a key impurity or degradation product of the antidepressant drug Citalopram. Its primary value lies in pharmaceutical research and development, where it is essential for method validation, stability studies, and ensuring the safety and efficacy of the final drug product. This compound is critically needed by analytical laboratories, quality control departments, and regulatory affairs teams within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify and quantify related substances in Citalopram Hydrobromide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to ensure specificity, accuracy, and precision.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific impurity under various stress conditions.
• Quality Control and Batch Release: Essential for in-house QC testing to ensure drug substance and product batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to comply with FDA, EMA, and ICH guidelines.
• Academic and Clinical Research: Supports research into the metabolism, pharmacokinetics, and degradation pathways of Citalopram.

Basic Information

Product Name	Citalopram Related Compound B
CAS No.	1332724-03-4
Molecular Formula	C20H21FN2O
Molecular Weight	324.39 g/mol
Synonyms	1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile; Citalopram Impurity B; Citalopram Related Substance B; Citalopram EP Impurity B; Desmethylcitalopram; Lu 10-202; Norcitalopram; 5-Cyano-1-(4-fluorophenyl)-1-[3-(dimethylamino)propyl]phthalane
EINECS	Contact for details

Quality Control

Every batch of Citalopram Related Compound B is manufactured and controlled under a strict quality management system. It undergoes comprehensive analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of specific impurities, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity and residual solvent levels, is provided with each shipment to support your regulatory and quality requirements.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment 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 reference spectrum
Identification (HPLC)	Retention time corresponds to 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.