Description

Clomipramine Hcl Ep Impurity G is a high-purity reference standard specifically identified as a process-related impurity of the pharmaceutical substance Clomipramine Hydrochloride. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the production and regulatory compliance of antidepressant medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity G in Clomipramine HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and analyze this specific impurity.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopoeial specifications (EP, USP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity samples for stability studies and specification justifications.
• Stability Studies: Used to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation studies.
• Research & Development: Aids in synthetic route optimization and process chemistry studies to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Clomipramine Hcl Ep Impurity G
CAS No.	1425793-87-8
Molecular Formula	C19H24Cl2N2
Molecular Weight	351.31 g/mol
Synonyms	3-Chloro-10,11-dihydro-5-(3-(dimethylamino)propyl)-5H-dibenzo[b,f]azepine; Clomipramine Impurity G; Clomipramine Related Compound G; Clomipramine EP Impurity G; Clomipramine Hydrochloride Impurity G; Desmethylclomipramine; Norclomipramine; 5H-Dibenzo[b,f]azepine-5-propanamine, 3-chloro-10,11-dihydro-N,N-dimethyl-
EINECS	Contact for details

Quality Control

Every batch of Clomipramine Hcl Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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