Description

Dm1 Impurity2 CAS NO 936481-22-0 is a high-purity chemical reference standard, specifically identified as a key process-related impurity or degradation product. This compound is critical for analytical method development, validation, and quality control in pharmaceutical research and manufacturing. It is primarily utilized by scientists and quality assurance professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors to ensure the safety, efficacy, and regulatory compliance of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in drug substances and drug products during stability studies and release testing.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor specific impurities.
• Quality Control & Assurance: Essential for establishing acceptance criteria and ensuring batch-to-batch consistency of APIs in compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance impurity profile.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Dm1 Impurity2
CAS No.	936481-22-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	DM1 Impurity 2; 936481-22-0; Maytansinoid impurity; Ansamitocin P-3 related impurity; DM1 Related Compound; SAR3419 Impurity; Targeted Cytotoxin Impurity
EINECS	Contact for details

Quality Control

Every batch of Dm1 Impurity2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques such as HPLC, MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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