Description

Citalopram Related Compound H (25 Mg) (1-(4'-Fluorophenyl)-1-(3-Dimethylaminopropyl)-5-Bromophthalane Hydrobromide) is a high-purity reference standard and impurity used in the analytical development and quality control of the antidepressant drug Citalopram. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods for Citalopram.
• Impurity Profiling & Control: Used to identify, monitor, and quantify this specific impurity during Citalopram API (Active Pharmaceutical Ingredient) manufacturing.
• Stability-Indicating Method Development: Essential for developing HPLC/UPLC methods to assess the stability and degradation pathways of Citalopram formulations.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and dossiers.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure batches of Citalopram meet stringent purity specifications.
• Research & Development (R&D): Used in pharmaceutical R&D to study the synthesis pathways and impurity formation mechanisms of Citalopram.

Basic Information

Product Name	Citalopram Related Compound H (25 Mg) (1-(4'-Fluorophenyl)-1-(3-Dimethylaminopropyl)-5-Bromophthalane Hydrobromide)
CAS No.	479065-02-6
Molecular Formula	C21H24BrFNO • HBr
Molecular Weight	485.25 g/mol
Synonyms	1-(4'-Fluorophenyl)-1-(3-Dimethylaminopropyl)-5-Bromophthalane Hydrobromide; Citalopram Impurity H; Citalopram Related Substance H; Citalopram EP Impurity H; Citalopram Hydrobromide Related Compound H; 5-Bromo-1-(4-fluorophenyl)-1-(3-(dimethylamino)propyl)isobenzofuran Hydrobromide; Lu 10-171-Br Impurity
EINECS	Contact for details

Quality Control

Our Citalopram Related Compound H is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) detailing batch-specific results are provided and can be tailored to support compliance with USP, EP, ICH, and other relevant pharmacopeial guidelines.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
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.