Description

Amitriptyline Hydrochloride Impurity F is a high-purity chemical reference standard essential for pharmaceutical research and development. This compound is critical for the accurate identification, quantification, and control of related substances in Amitriptyline Hydrochloride drug substances and finished products. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and biotechnology industries to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) for the identification and quantification of specified impurities in Amitriptyline Hydrochloride active pharmaceutical ingredients (APIs).
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC testing of pharmaceutical raw materials and finished drug products to ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to monitor the formation of degradation products in Amitriptyline Hydrochloride formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Pharmacopeial Testing: Supports testing to meet the monograph specifications of the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopeias.

Basic Information

Product Name	Amitriptyline Hydrochloride Impurity F
CAS No.	1246833-15-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-δ5γ-propylamine Hydrochloride Impurity F; Amitriptyline HCl Impurity F; Amitriptyline Related Compound F; 5-(3-Dimethylaminopropylidene)-10,11-dihydro-5H-dibenzo[a,d]cycloheptene Hydrochloride Impurity; Impurity F of Amitriptyline Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Amitriptyline Hydrochloride Impurity F is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use under cGMP conditions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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