Description

Sugammadex Impurity 52 is a designated impurity of the neuromuscular blockade reversal agent, Sugammadex. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sugammadex API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to monitor and control impurity levels according to ICH guidelines.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability testing of Sugammadex formulations.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize the synthesis pathway of Sugammadex to minimize the formation of this impurity.

Basic Information

Product Name	Sugammadex Impurity 52
CAS No.	2412952-88-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sugammadex Related Compound 52; Bridion Impurity 52; (2R,3R,4S,5R,6R)-6-[[(1R,2R,3S,4R,5S)-5-carboxy-2,3,4-tris(sulfanylmethyl)cyclopentyl]sulfanylmethyl]-3,4,5-tris(sulfanylmethyl)oxane-2-carboxylic acid; γ-Cyclodextrin derivative impurity; Org 25969 Impurity
EINECS	Contact for details

Quality Control

Our Sugammadex Impurity 52 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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