Description

Oxaliplatin Impurity D is a specified impurity and degradation product of the widely used chemotherapeutic agent Oxaliplatin. Its identification, characterization, and control are critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). This compound is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for use as a certified reference standard in quality control, method development, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Oxaliplatin API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Stability Studies & Forced Degradation: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Oxaliplatin.
• Pharmacopoeial Testing: Applied as a system suitability component in testing to meet pharmacopoeial monographs (e.g., USP, EP, JP).

Basic Information

Product Name	Oxaliplatin Impurity D
CAS No.	61758-77-8
Molecular Formula	C8H14N2O4Pt
Molecular Weight	397.30 g/mol
Synonyms	(1R,2R)-Cyclohexane-1,2-diamine; (SP-4-2)-Diammine[1R,2R-cyclohexanediamine-N,N']platinum; (1R,2R)-Diaminocyclohexaneplatinum(II); DACH-Platinum; (1R,2R)-DACH-Pt; Oxaliplatin Related Compound D; Platinum, diammine[(1R,2R)-1,2-cyclohexanediamine-N,N']-, (SP-4-2)-
EINECS	Contact for details

Quality Control

Every batch of Oxaliplatin Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and mass spectrometry to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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	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 unknown impurity: ≤ 0.5% 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.