Description

Chlorambucil Impurity E CAS NO 1988791-13-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Chlorambucil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in the production of oncology medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of the chemotherapy drug Chlorambucil.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and GC-MS methods to establish detection limits, quantification, and system suitability for impurity analysis.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity identification and characterization.
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product in Chlorambucil formulations under various storage conditions.
• Research & Development: Utilized in pharmacokinetic and metabolic studies to understand the degradation pathways and safety profile of Chlorambucil.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch analysis to ensure product purity and consistency.

Basic Information

Product Name	Chlorambucil Impurity E
CAS No.	1988791-13-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-[Bis(2-chloroethyl)amino]benzenebutanoic acid Impurity E; Chlorambucil Related Compound E; 4-[p-[Bis(2-chloroethyl)amino]phenyl]butyric acid Impurity; Chlorambucil EP Impurity E; Chlorambucil USP Impurity E; Leukeran Impurity E; (4-(4-(Bis(2-chloroethyl)amino)phenyl)butanoic acid) related substance E
EINECS	Contact for details

Quality Control

Our Chlorambucil Impurity E is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the requirements for use as a pharmaceutical reference standard. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced chromatographic and spectroscopic methods. We support compliance with major pharmacopoeial standards (USP, EP, BP) and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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