Description

Mitoxantrone Impurity A (CAS NO 89991-52-6) is a critical reference standard used in the pharmaceutical development and quality control of the antineoplastic agent Mitoxantrone. This high-purity impurity is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Mitoxantrone Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific impurity over time and under various stress conditions.
• Quality Control & Batch Release: A critical component in the quality control workflow to ensure that Mitoxantrone API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and demonstrate comprehensive control of the drug substance.
• Research & Development: Used in R&D to study the degradation pathways, pharmacokinetics, and toxicological profile of Mitoxantrone and its related substances.

Basic Information

Item	Details
Product Name	Mitoxantrone Impurity A
CAS No.	89991-52-6
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 A; 1,4-Dihydroxy-5,8-bis[2-(2-hydroxyethylamino)ethylamino]anthra-9,10-quinone; Mitoxantrone Impurity; Novantrone Impurity A; DHAQ Impurity; CL 232315 Impurity A
EINECS	Contact for details

Quality Control

Every batch of Mitoxantrone Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and structural confirmation, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.