Description

Maytansinoid Dm4 Impurity is a critical reference standard used in the development and quality control of antibody-drug conjugates (ADCs). This high-purity compound is essential for researchers and manufacturers to accurately identify, quantify, and control process-related impurities, ensuring the safety and efficacy of final therapeutic products. It is primarily utilized by pharmaceutical R&D teams, analytical laboratories, and quality assurance departments within the biopharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as an analytical standard for the identification and quantification of the DM4 impurity in ADC drug substances and products.
• ADC Process Development: Used to study and optimize conjugation and purification processes to minimize impurity formation.
• Method Development and Validation: Critical for developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Stability Studies: Employed to monitor impurity levels in stability samples to assess drug product shelf-life.
• Regulatory Compliance: Supports regulatory filings (e.g., with the FDA, EMA) by providing characterized impurity standards for specification setting.
• Quality Control Testing: Used in routine QC release testing of ADC batches to ensure they meet predefined purity specifications.

Basic Information

Product Name	Maytansinoid Dm4 Impurity
CAS No.	936481-24-2
Molecular Formula	C39H55ClN4O10S
Molecular Weight	823.39 g/mol
Synonyms	DM4 Impurity; Maytansinoid DM4 Related Compound; N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-maytansine; Ansamitocin P-3 Derivative Impurity; S-methyl DM4 Impurity; ADC Linker-Payload Impurity; mertansine impurity; Tubulin inhibitor impurity
EINECS	Contact for details

Quality Control

Every batch of Maytansinoid Dm4 Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with the high 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 at -20°C or below under an inert atmosphere. This product is hygroscopic (moisture-sensitive) and light-sensitive. Allow the vial to warm to room temperature in a desiccator before opening to minimize moisture uptake.

Specification

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

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