Description

Mitomycin Impurity 6 CAS NO 99745-88-7 is a specified impurity of the potent antineoplastic antibiotic Mitomycin C, critical for ensuring the purity and safety profile of the active pharmaceutical ingredient (API). This compound is essential for pharmaceutical research, development, and quality control laboratories focused on analytical method validation and regulatory compliance. It serves as a vital reference standard for manufacturers and analytical scientists in the pharmaceutical and biotechnology industries who require high-purity materials for impurity identification, quantification, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Mitomycin C and related drug substances.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, validating, and transferring impurity profiling methods in compliance with ICH Q2(R1) and Q3A/B guidelines.
• Quality Control & Batch Release Testing: Used in QC laboratories to monitor and control impurity levels in Mitomycin C API batches, ensuring they meet pharmacopeial (USP, EP) and internal specifications.
• Stability Studies & Forced Degradation: Employed to identify and track degradation products formed under various stress conditions (light, heat, oxidation) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Mitomycin C, supporting formulation development.

Basic Information

Product Name	Mitomycin Impurity 6
CAS No.	99745-88-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-Aminomitomycin; Mitomycin C Impurity 6; 7-Amino-1a,2,8,8a-tetrahydro-1H-azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-5-methyl-; Mitomycin derivative; Azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-5-methyl-, (1aS,8S,8aR,8bR)-; (1aS,8S,8aR,8bR)-6-Amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-5-methyl-azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione
EINECS	Contact for details

Quality Control

Every batch of Mitomycin Impurity 6 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for assay, related substances, and other critical parameters. Our quality commitment aligns with cGMP principles and supports compliance with global pharmacopeial standards for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere (e.g., nitrogen or argon) at a controlled room temperature, typically between 15-25°C (59-77°F), or as specified on the certificate. The product is light-sensitive and easily oxidized; prolonged exposure to light, air, or elevated temperatures should be avoided to maintain stability and purity.

Specification

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

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