Description

Irinotecan Impurity 20 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of process-related impurities in the active pharmaceutical ingredient (API) Irinotecan Hydrochloride. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, ensuring drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis.
• Impurity Profiling: Critical for identifying, characterizing, and controlling specified and unspecified impurities in Irinotecan HCl API batches according to ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity identity and qualification data.
• Stability Studies: Used as a marker to monitor impurity formation and degradation pathways in drug substance and drug product stability testing.
• Quality Control (QC) Testing: Serves as a system suitability and quantification standard in routine QC release testing of Irinotecan HCl API.
• Research & Development: Facilitates synthetic route optimization and process chemistry studies by tracking the formation and purge of this specific impurity.

Basic Information

Product Name	Irinotecan Impurity 20 Hcl
CAS No.	870527-52-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Irinotecan Related Compound 20 Hydrochloride; Irinotecan HCl Impurity 20; Camptothecin-11 Impurity 20 HCl; (4S)-4,11-Diethyl-4-hydroxy-9-[(4-piperidinopiperidino)carbonyloxy]-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione Hydrochloride; CPT-11 Impurity 20 HCl; 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin Impurity 20 Hydrochloride
EINECS	Contact for details

Quality Control

Our Irinotecan Impurity 20 Hcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, identity confirmation (IR, MS), and residual solvent analysis to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting traceability and compliance with cGMP and ICH Q3A/B guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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