Description

Maprotiline Impurity D is a designated impurity of the tetracyclic antidepressant Maprotiline, used as a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Maprotiline API and finished dosage forms.
• Method Development and Validation (HPLC/GC): Used to establish and validate chromatographic methods for impurity profiling.
• Quality Control and Batch Release: Critical for routine testing to ensure Maprotiline products meet pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) filings.
• Research and Development: Used in synthetic chemistry and metabolic studies to understand the degradation pathways of Maprotiline.

Basic Information

Product Name	Maprotiline Impurity D
CAS No.	38982-14-8
Molecular Formula	C20H23N
Molecular Weight	277.40 g/mol
Synonyms	1-(3-Methylaminopropyl)dibenzo[b,e]bicyclo[2.2.2]octadiene; N-Methylmaprotiline; Desmethylmaprotiline Impurity; Maprotiline Related Compound D; LU 10-202; LU-10-202; 3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)-N-methylpropan-1-amine
EINECS	Contact for details

Quality Control

Our Maprotiline Impurity D is produced and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with lot-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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