Description

Pixantrone Impurity 2 is a designated impurity standard of the antineoplastic agent Pixantrone. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in the production and regulatory compliance of Pixantrone-based drug products.

Application

• Primary use as a certified reference standard for the identification and quantification of Pixantrone Impurity 2 in active pharmaceutical ingredient (API) and finished drug product batches.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) to ensure specificity, accuracy, and robustness.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles over time and under stress conditions.
• Used for pharmacopeial compliance, supporting submissions to regulatory bodies like the US FDA, EMA, and ICH guidelines (Q3A, Q3B).
• Serves as a key reagent in process chemistry research to understand and control the formation of this impurity during Pixantrone synthesis.
• Supports comparability studies for generic drug development and post-approval manufacturing changes.

Basic Information

Product Name	Pixantrone Impurity 2
CAS No.	1430561-04-8
Molecular Formula	C21H24N6O3
Molecular Weight	408.46 g/mol
Synonyms	Pixantrone Related Compound 2; 5-[(3-Amino-2-hydroxypropyl)amino]-1-methyl-7H-pyrazolo[4,3-e][1,2,4]triazolo[1,5-c]pyrimidin-7-one; BBR 3438 Impurity 2; UNII-7Z8Q8V8JQN; 7H-Pyrazolo[4,3-e][1,2,4]triazolo[1,5-c]pyrimidin-7-one, 5-[(3-amino-2-hydroxypropyl)amino]-1-methyl-
EINECS	Contact for details

Quality Control

Every batch of Pixantrone Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material should be kept in a dry environment and handled under inert conditions if specified.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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