Description

Plerixafor Impurity 14 is a specified impurity of the active pharmaceutical ingredient (API) Plerixafor (Mozobil®), a hematopoietic stem cell mobilizer. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Plerixafor drug substances and products. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Plerixafor API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels against ICH Q3A/B guidelines, ensuring batch-to-batch consistency.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Plerixafor to minimize the formation of this impurity.

Basic Information

Product Name	Plerixafor Impurity 14
CAS No.	294677-00-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane] Impurity; AMD3100 Impurity 14; Mozobil Impurity 14; Plerixafor Related Compound 14; 1,1'-[1,4-Phenylenebis(methylene)]bis-1,4,8,11-tetraazacyclotetradecane (Impurity); Cyclam Derivative Impurity
EINECS	Contact for details

Quality Control

Our Plerixafor Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for use as a reference standard. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH, USP, and EP guidelines for impurities.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.