Description

Oxaliplatin Ep Impurity B is a critical pharmaceutical reference standard used in the quality control and development of the anticancer drug Oxaliplatin. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a known impurity for analytical method validation and stability studies. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and quality assurance of platinum-based chemotherapeutic agents.

Application

• Primary use as a pharmaceutical reference standard for Oxaliplatin impurity profiling.
• Critical component in analytical method development and validation (HPLC, LC-MS) for drug substance and product testing.
• Used in stability studies to monitor impurity formation and degradation pathways of Oxaliplatin.
• Essential for regulatory compliance and filing (e.g., ICH guidelines, EP/USP monographs) requiring impurity identification and qualification.
• Serves as a research tool in pharmacokinetic and metabolic studies of platinum-based drugs.
• Utilized in quality control laboratories for routine batch release testing of Oxaliplatin API and finished dosage forms.

Basic Information

Product Name	Oxaliplatin Ep Impurity B
CAS No.	89955-85-1
Molecular Formula	C8H14N2O4Pt
Molecular Weight	397.30 g/mol
Synonyms	Oxaliplatin Impurity B; (SP-4-2)-[(1R,2R)-Cyclohexane-1,2-diamine-κN,κN'] [ethanedioato(2-)-κO1,κO2]platinum; (1R,2R)-1,2-Diaminocyclohexaneoxalatoplatinum(II); Oxaliplatin Related Compound B; trans-Oxalato(trans-l-1,2-diaminocyclohexane)platinum(II); Oxaliplatin EP Impurity B; Oxaliplatin USP Impurity B
EINECS	Contact for details

Quality Control

Our Oxaliplatin Ep Impurity B is manufactured under strict quality systems to meet the exacting standards of pharmaceutical impurity analysis. Each batch is characterized and tested using validated analytical methods, including HPLC, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (EP, USP).

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 COA. 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	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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