Description

Mitoxantrone Impurity B is a specified impurity and degradation product of the antineoplastic agent Mitoxantrone. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is essential for laboratories and manufacturers involved in ensuring the purity, safety, and regulatory compliance of Mitoxantrone drug substances and finished products. Its precise characterization is vital for meeting stringent pharmacopeial standards in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Mitoxantrone Active Pharmaceutical Ingredients (APIs) and formulations.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing of bulk drug substances to ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to track degradation pathways and establish shelf-life specifications for Mitoxantrone products.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the formation and mitigation of process-related impurities.

Basic Information

Product Name	Mitoxantrone Impurity B
CAS No.	80189-44-2
Molecular Formula	C22H28N4O6
Molecular Weight	444.48 g/mol
Synonyms	1,4-Dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]-9,10-anthracenedione; Mitoxantrone Related Compound B; 1,4-Dihydroxy-5,8-bis[2-(2-hydroxyethylamino)ethylamino]anthra-9,10-quinone; Mitoxantrone Impurity 2; Mitoxantrone EP Impurity B; Mitoxantrone USP Related Compound B; NSC 301739; DHAQ Impurity
EINECS	Contact for details

Quality Control

Every batch of Mitoxantrone Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, NMR, MS) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH 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). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	Blue to dark blue solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.