Description

Amitriptyline Ep Impurity E Hcl (Mixture Of Diastereomers) CAS NO 26360-49-6 is a high-purity chemical reference standard specifically used in the analytical profiling of Amitriptyline Hydrochloride. This compound matters as a critical impurity marker for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers engaged in method development, validation, and stability studies for tricyclic antidepressant drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Amitriptyline Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing and validating chromatographic methods to monitor impurity profiles as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to track the formation of this specific degradation product.
• Pharmacopoeial Compliance: Supports testing to meet the stringent impurity limits specified in monographs of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other international pharmacopoeias.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Quality Control & Batch Release: Enables in-house QC testing of API batches to ensure they meet predefined specification limits for impurities.

Basic Information

Item	Details
Product Name	Amitriptyline Ep Impurity E Hcl (Mixture Of Diastereomers)
CAS No.	26360-49-6
Molecular Formula	C20H23N.HCl
Molecular Weight	313.86 g/mol (Free base: 277.40 g/mol)
Synonyms	Amitriptyline Impurity E; Amitriptyline Related Compound E; 10,11-Dihydro-5-(3-methylaminopropylidene)-5H-dibenzo[a,d]cycloheptene Hydrochloride; (E)-3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methylpropan-1-amine Hydrochloride; Amitriptyline EP Impurity E; USP Amitriptyline Related Compound E; trans-Amitriptyline Hydrochloride; (E)-Amitriptyline Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Amitriptyline Ep Impurity E Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and chromatographic testing to ensure compliance with pharmacopoeial standards (USP/EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage under inert atmosphere, please contact us for specific recommendations.

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)	≥ 95.0% (on anhydrous basis)
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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