Description

Nortriptyline Impurity CAS NO 6682-29-7 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Nortriptyline, a tricyclic antidepressant. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific impurity during the development and quality control of Nortriptyline API and its formulations.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (HPLC, UPLC, GC) to ensure accurate detection and separation of impurities.
• Stability Studies and Forced Degradation Testing: Employed to understand the degradation pathways of Nortriptyline and to qualify related substances that may form under various stress conditions (light, heat, humidity).
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA, ICH) that require detailed impurity characterization and control strategies as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) and Batch Release Testing: Acts as a system suitability standard and a quantitative calibrant in routine QC labs to ensure every batch of Nortriptyline API meets stringent purity specifications.
• Research and Development (R&D): Used in synthetic chemistry R&D to study reaction mechanisms, optimize processes to minimize impurity formation, and synthesize impurity markers.

Basic Information

Product Name	Nortriptyline Impurity
CAS No.	6682-29-7
Molecular Formula	C17H19NO
Molecular Weight	253.34 g/mol
Synonyms	10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-one, O-(3-Dimethylaminopropyl)oxime; 5H-Dibenzo[a,d]cyclohepten-5-one, 10,11-dihydro-, O-[3-(dimethylamino)propyl]oxime; Nortriptyline Oxime; Nortriptyline Related Compound; Nortriptyline Impurity O
EINECS	Contact for details

Quality Control

Our Nortriptyline Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results and confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
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
Water Content (KF)	≤ 0.5%

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