Description

Sugammadex Impurity 21 is a high-purity reference standard used in the analytical profiling and quality control of the neuromuscular blockade reversal agent, Sugammadex. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sugammadex active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure Sugammadex meets stringent pharmacopeial (e.g., USP, EP) specifications for impurity limits.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish shelf-life and storage recommendations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Used to study and optimize the synthesis and purification processes of Sugammadex to minimize the formation of this impurity.

Basic Information

Product Name	Sugammadex Impurity 21
CAS No.	2412952-93-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bridion Impurity 21; Org 25969 Impurity 21; (2-Hydroxypropyl)-γ-cyclodextrin Impurity 21; γ-Cyclodextrin derivative impurity; Sugammadex Related Compound 21; Selective Relaxant Binding Agent Impurity; Rocuronium and Vecuronium Reversal Agent Impurity
EINECS	Contact for details

Quality Control

Every batch of Sugammadex Impurity 21 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.