Description

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

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Amitriptyline Hydrochloride.
• Analytical Research: Used in HPLC, UPLC, and GC methods for the precise identification and quantification of Impurity E in drug substances and products.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Pharmacopeial Testing: Used to ensure compliance with monograph specifications in USP, EP, BP, and other international pharmacopeias.
• Process Chemistry & Development: Aids in optimizing synthesis and purification processes by tracking and minimizing the formation of this impurity.

Basic Information

Item	Details
Product Name	Amitriptyline Hydrochloride Impurity E
CAS No.	27867-02-3
Molecular Formula	C20H23N
Molecular Weight	277.40 g/mol
Synonyms	10,11-Dihydro-5-(3-methylaminopropylidene)-5H-dibenzo[a,d]cycloheptene; 5-(3-Methylaminopropylidene)-10,11-dihydro-5H-dibenzo[a,d]cycloheptene; Amitriptyline Impurity E; Amitriptyline Related Compound E; Nortriptyline Impurity; Desmethyl Amitriptyline
EINECS	Contact for details

Quality Control

Every batch of Amitriptyline Hydrochloride Impurity E is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and ensure high purity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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