Description

Plerixafor Impurity 9 is a specified impurity of Plerixafor (Mozobil®), a pharmaceutical agent used in stem cell mobilization. This compound, identified by CAS No. 181181-38-4, is critical for analytical research and quality control in the development and manufacturing of the active pharmaceutical ingredient (API). It is primarily used by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Plerixafor Impurity 9 in API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity levels and ensure they remain within ICH Q3A/B regulatory guidelines.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to determine drug product shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Used by chemists to understand and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Plerixafor Impurity 9
CAS No.	181181-38-4
Molecular Formula	C28H54N8
Molecular Weight	502.79 g/mol
Synonyms	1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane] Impurity; AMD3100 Impurity 9; Mozobil Impurity 9; 1,1'-[1,4-Phenylenebis(methylene)]bis-1,4,8,11-tetraazacyclotetradecane; Bicyclam Impurity; Plerixafor Related Compound 9
EINECS	Contact for details

Quality Control

Our Plerixafor Impurity 9 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 high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

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 must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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