Description

Cisplatin Impurity 1 is a high-purity reference standard used for the identification, qualification, and quantification of related substances in the active pharmaceutical ingredient (API) Cisplatin. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling precise analytical control during manufacturing and regulatory submission. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs teams involved in the development and production of platinum-based chemotherapeutic agents.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development, validation, and routine quality control testing of Cisplatin API and finished drug products.
• Impurity Profiling and Identification: Critical for characterizing the impurity profile of Cisplatin batches to ensure compliance with pharmacopeial monographs (USP, EP, JP) and ICH Q3A/B guidelines.
• Stability Studies: Used as a marker to monitor the formation of degradation products in stability testing programs for Cisplatin formulations.
• Regulatory Documentation: Supports the preparation of regulatory filings (e.g., DMF, CMC sections of IND/NDA) by providing definitive impurity identification and control strategies.
• Method Transfer and Verification: Serves as a system suitability and calibration standard during the transfer of analytical methods between laboratories or to contract manufacturing organizations (CMOs).
• Research and Development: Utilized in academic and industrial research to study the degradation pathways, metabolism, and chemical behavior of Cisplatin and related platinum complexes.

Basic Information

Product Name	Cisplatin Impurity 1
CAS No.	53861-42-0
Molecular Formula	C2H6Cl2N2Pt
Molecular Weight	372.06 g/mol
Synonyms	cis-Diamminedichloroplatinum(II) Impurity 1; Platinum, diamminedichloro-, (SP-4-2)-; cis-Platinum(II) diammine dichloride impurity; Dichlorodiammineplatinum(II) related substance A; cis-[PtCl2(NH3)2] Impurity; CDDP Impurity 1; (SP-4-2)-Diamminedichloroplatinum
EINECS	Contact for details

Quality Control

Every batch of Cisplatin Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and mass spectrometry to ensure compliance with the highest standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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