Description

Plerixafor Impurity 29 is a designated chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of Plerixafor, a key pharmaceutical agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and method development. The use of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control of Plerixafor (Mozobil®) active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and ensure drug product shelf-life.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive identification and quantification data for specified impurities.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing in GMP manufacturing environments.

Basic Information

Item	Detail
Product Name	Plerixafor Impurity 29
CAS No.	169783-37-3
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 29; Mozobil Impurity 29; Plerixafor Related Compound 29; Cyclam Derivative Impurity
EINECS	Contact for details

Quality Control

Our Plerixafor Impurity 29 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and chromatographic data.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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