Description

Plerixafor Impurity 12 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 method development and validation process to ensure the purity and safety of the final drug product. It is primarily required by analytical chemists, quality control (QC) laboratories, and regulatory affairs professionals within the pharmaceutical and biotechnology sectors for impurity profiling and compliance with stringent regulatory guidelines (e.g., ICH Q3A/B).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Plerixafor Impurity 12 in Plerixafor API and its formulated drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods to monitor impurity levels throughout the drug lifecycle.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure API and drug product batches meet predefined impurity specifications and are safe for clinical use.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data on impurity identity, structure, and toxicological qualification for inclusion in regulatory filings (e.g., CMC sections of IND, NDA, MAA) to agencies like the FDA and EMA.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Plerixafor synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Plerixafor Impurity 12
CAS No.	13380-07-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane] Impurity; Mozobil Impurity 12; AMD3100 Impurity 12; 1,1'-[1,4-Phenylenebis(methylene)]bis-1,4,8,11-tetraazacyclotetradecane Related Compound; Plerixafor Related Compound; Cyclam Derivative Impurity
EINECS	Contact for details

Quality Control

Our Plerixafor Impurity 12 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. Certificates of Analysis (COA) are provided, detailing comprehensive results for identity, purity, and impurity profiles, supporting compliance with current Good Manufacturing Practice (cGMP) and ICH guidelines for pharmaceutical reference standards.

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 nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.