Description

Carboplatin Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the widely used chemotherapy drug Carboplatin by serving as a key marker in impurity profiling. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control and release testing of Carboplatin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and other chromatographic methods for impurity detection and quantification.
• Stability Studies: Employed as a marker to track the formation of specific degradation products during forced degradation and long-term stability studies of Carboplatin formulations.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing identified and characterized impurity profiles.
• Research & Development: Facilitates research into the metabolism, degradation pathways, and pharmacokinetics of Carboplatin and related platinum-based chemotherapeutics.
• Pharmacopoeial Testing: Used in testing to comply with pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for known and unknown impurities.

Basic Information

Product Name	Carboplatin Impurity 9
CAS No.	63700-88-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carboplatin Related Compound; Cyclobutane-1,1-dicarboxylato(2-)-O,O'](1,2-cyclohexanediamine-N,N')platinum(II); Platinum, [1,1-cyclobutanedicarboxylato(2-)-O,O'][(1R,2R)-1,2-cyclohexanediamine-N,N']-, (SP-4-2)-; Carboplatin Impurity; Carboplatin Specified Impurity; Platinum complex impurity of Carboplatin
EINECS	Contact for details

Quality Control

Every batch of Carboplatin Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic data, and storage conditions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label and Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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