Description

n-Methyl Impurity CAS NO 1427429-04-6 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for identifying, quantifying, and controlling process-related impurities in active pharmaceutical ingredients (APIs) to ensure final product safety and efficacy. It is an essential tool for analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical manufacturing and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific process-related impurities in drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity detection.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits (ICH guidelines).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used to track the formation of degradation products in stability testing of drug substances and formulations under various ICH conditions.
• Research and Development: Facilitates synthetic route optimization and process chemistry studies by helping to identify and eliminate impurity formation during API synthesis.

Basic Information

Product Name	n-Methyl Impurity
CAS No.	1427429-04-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,2,3,4-Tetrahydro-2-methylisoquinoline-6,7-diol; 2-Methyl-1,2,3,4-tetrahydroisoquinoline-6,7-diol; 6,7-Dihydroxy-2-methyl-1,2,3,4-tetrahydroisoquinoline; n-Methylnorlaudanosoline; MNLS; Methyl impurity of certain catecholamine derivatives; Process-related impurity
EINECS	Contact for details

Quality Control

Every batch of our n-Methyl Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A/B and cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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 solid
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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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