Description

Plerixafor Impurity 7 is a specified impurity of Plerixafor, a critical pharmaceutical agent used in stem cell mobilization. This compound is essential for the analytical profiling and quality control of Plerixafor active pharmaceutical ingredient (API) and its finished drug products. It serves as a key reference standard for pharmaceutical R&D and quality assurance laboratories to ensure product purity, safety, and regulatory compliance. Its precise characterization is vital for manufacturers and researchers focused on hematology and oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Plerixafor API and drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor impurity profiles and degradation pathways during forced degradation and long-term stability testing of Plerixafor formulations.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Process Chemistry & Optimization: Used to track and control the formation of this specific impurity during the synthesis and purification of Plerixafor.
• Pharmacopoeial Testing: Applicable for testing against monographs in pharmacopoeias such as USP or EP where impurity specifications are defined.

Basic Information

Product Name	Plerixafor Impurity 7
CAS No.	117152-72-4
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 7; Plerixafor Related Compound 7; Mozobil Impurity 7; Cyclam Derivative Impurity; 1,4-Bis(1,4,8,11-tetraazacyclotetradecan-1-ylmethyl)benzene (related impurity)
EINECS	Contact for details

Quality Control

Our Plerixafor Impurity 7 is manufactured under strict quality management systems. Each batch is subjected to rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurity profile. Our quality standards are designed to meet the stringent requirements of pharmaceutical R&D and regulatory compliance.

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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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