Description

Maprotiline Related Compound D is a high-purity chemical reference standard, essential for analytical and research applications. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Maprotiline. It is primarily used by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of a specific impurity in Maprotiline drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity analysis.
• Quality Control and Release Testing: Employed in routine QC testing of Maprotiline batches to ensure compliance with pharmacopoeial standards (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to monitor impurity formation over time.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Utilized in synthetic chemistry R&D for studying degradation pathways and synthesizing related compounds.

Basic Information

Product Name	Maprotiline Related Compound D
CAS No.	38849-14-8
Molecular Formula	C20H23N
Molecular Weight	277.40 g/mol
Synonyms	9,10-Ethanoanthracene-9(10H)-propanamine, 2-methyl-; 2-Methyl-9,10-ethanoanthracene-9(10H)-propanamine; 1-(3-Aminopropyl)-2-methyl-9,10-dihydro-9,10-[3,4]epiphenylanthracene; Maprotiline Impurity D; Maprotiline EP Impurity D; Maprotiline Related Substance D
EINECS	Contact for details

Quality Control

Every batch of Maprotiline Related Compound D is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and methods. We support compliance with ICH Q3A/B, USP, and European Pharmacopoeia guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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