Description

Sugammadex Impurity 22 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 safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and contract research organizations (CROs) focused on advanced anesthesia drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Sugammadex active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control & Assurance: Used in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Process Chemistry Research: Aids in understanding and optimizing the Sugammadex synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Sugammadex Impurity 22
CAS No.	2412952-94-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bridion Impurity 22; Org 25969 Impurity 22; γ-Cyclodextrin derivative impurity; (2-Hydroxypropyl)-γ-cyclodextrin impurity; Sugammadex Related Compound 22; Process Impurity of Sugammadex; RO-101 Impurity
EINECS	Contact for details

Quality Control

Every batch of Sugammadex Impurity 22 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.