Description

Plerixafor Impurity CAS NO 351472-73-6 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Plerixafor, a critical therapeutic agent. This impurity is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on hematology and oncology drug development.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Plerixafor active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Plerixafor API meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation of degradation products in Plerixafor formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Plerixafor synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Plerixafor Impurity
CAS No.	351472-73-6
Molecular Formula	C28H54N8
Molecular Weight	502.78 g/mol
Synonyms	1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane]; AMD3465 Hexahydrobromide Impurity; JM 3100 Impurity; Plerixafor Related Compound; Mozobil Impurity; Cyclam Derivative Impurity; CXCR4 Antagonist Impurity
EINECS	Contact for details

Quality Control

Our Plerixafor Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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