Description

Maprotiline Hydrochloride Ep Impurity E is a high-purity reference standard used in the quality control and analytical development of the antidepressant drug Maprotiline Hydrochloride. This impurity is critical for ensuring the safety and efficacy of the final pharmaceutical product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopoeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control of Maprotiline Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Stability Studies: Employed to monitor the formation of degradation products in Maprotiline Hydrochloride under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., CMC sections for FDA, EMA) to demonstrate control over the drug substance impurity profile.
• Pharmacopoeial Testing: Directly supports testing procedures as specified in monographs of the European Pharmacopoeia (EP) and other international compendia.
• Research & Development: Utilized in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of Maprotiline.

Basic Information

Product Name	Maprotiline Hydrochloride Ep Impurity E
CAS No.	23941-38-0
Molecular Formula	C20H23N•HCl
Molecular Weight	313.86 g/mol (as free base: 277.40 g/mol)
Synonyms	Maprotiline Related Compound E; 1-(3-Methylaminopropyl)dibenzo[b,e]bicyclo[2.2.2]octadiene Hydrochloride; Maprotiline HCl Impurity E; Maprotiline EP Impurity E; 3-(9,10-Dihydro-9,10-ethanoanthracen-9-yl)-N-methylpropan-1-amine Hydrochloride; Ludiomil Impurity E; Maprotiline Hydrochloride Related Substance E
EINECS	Contact for details

Quality Control

Every batch of Maprotiline Hydrochloride Ep Impurity E 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 compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters.

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 dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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