Description

Plerixafor Impurity 36 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Plerixafor. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of Plerixafor-based drug products. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in research, development, and commercial production within the oncology and stem cell mobilization therapeutic areas.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Plerixafor Impurity 36 in API and finished drug product batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods for Plerixafor.
• Stability Studies & Forced Degradation: Used to monitor impurity profiles and establish degradation pathways during drug substance and product stability testing.
• Quality Control & Batch Release: Essential for setting impurity specifications and ensuring each production lot meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Regulatory Submissions: Provides necessary data on impurity identity, structure, and levels for regulatory filings (IND, NDA, ANDA) with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and controlling the formation of this specific impurity during the synthesis and purification of Plerixafor API.

Basic Information

Product Name	Plerixafor Impurity 36
CAS No.	1007858-12-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane] Impurity; AMD3100 Impurity 36; Mozobil Impurity 36; Plerixafor Related Compound 36; Cyclam Derivative Impurity; CXCR4 Antagonist Impurity; Bicyclam Impurity
EINECS	Contact for details

Quality Control

Every batch of Plerixafor Impurity 36 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical characterization using advanced techniques including HPLC, MS, and NMR to confirm identity and establish purity. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) with detailed chromatographic data are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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