Description

Mitomycin Impurity 7 is a specified impurity and degradation product of the potent antineoplastic agent Mitomycin C. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and quality control processes. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Mitomycin C-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Mitomycin C Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Mitomycin C and establish appropriate shelf-life specifications.
• Quality Control & Batch Release: A critical component in the quality control laboratory for routine testing of API and drug product batches against established impurity limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA, ICH) by providing characterized impurity data.
• Process Chemistry Research: Used to monitor and control impurity formation during the synthesis, purification, and scale-up of Mitomycin C manufacturing processes.

Basic Information

Product Name	Mitomycin Impurity 7
CAS No.	98462-75-0
Molecular Formula	C15H18N4O5
Molecular Weight	334.33 g/mol
Synonyms	7-Aminomitomycin; Mitomycin 7-Amino Derivative; 7-Amino-1a,2,8,8a-tetrahydro-1a-hydroxy-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione; 7-AMC; Mitomycin C Impurity 7; Mitomycin Related Compound 7
EINECS	Contact for details

Quality Control

Every batch of Mitomycin Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with ICH Q3A, Q3B, and pharmacopeial standards. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.