Description

Plerixafor Impurity 28 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Plerixafor. This compound is critical for ensuring the purity, safety, and efficacy of Plerixafor-based drug products by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of stem cell mobilizers.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Plerixafor API and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure Plerixafor batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Plerixafor formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections of IND/NDA) by providing definitive characterization of impurity profiles.
• Research & Development: Utilized in synthetic chemistry research to understand and control impurity formation during the manufacturing process of Plerixafor.

Basic Information

Item	Details
Product Name	Plerixafor Impurity 28
CAS No.	732221-38-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Plerixafor Related Compound 28; AMD3100 Impurity 28; 1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane] Impurity; JM 3100 Impurity 28; Mozobil Impurity 28; Cyclam Derivative Impurity; 1,4-Bis(1,4,8,11-tetraazacyclotetradecan-1-ylmethyl)benzene Impurity
EINECS	Contact for details

Quality Control

Every batch of Plerixafor Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing chromatographic purity, assay results, and spectroscopic identification data.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation and ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
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.