Description

Sugammadex Impurity 69 is a designated process-related impurity or degradation product of the neuromuscular blockade reversal agent, Sugammadex. This compound is critical for pharmaceutical research and development, specifically for method development, validation, and ensuring the purity and safety profile of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries for comprehensive impurity profiling and compliance with stringent ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Sugammadex.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to detect and quantify this specific impurity.
• Quality Control & Assurance: Employed in routine batch testing of Sugammadex API to monitor impurity levels and ensure they remain within specified limits.
• Stability Studies: Used to identify and track the formation of this impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding the formation pathway during API synthesis, helping to optimize manufacturing processes to minimize impurity generation.

Basic Information

Product Name	Sugammadex Impurity 69
CAS No.	426267-22-3
Molecular Formula	C72H104Na8O48S8
Molecular Weight	2178.0 g/mol
Synonyms	Bridion Impurity 69; γ-Cyclodextrin, 6A,6B,6C,6D,6E,6F,6G,6H-octakis-S-[2-carboxylato(mercaptoacetato)aurio(1-)]octakis(thio)-, octasodium salt; Per-6-mercapto-γ-cyclodextrin octasodium salt gold complex; Sugammadex Related Compound 69
EINECS	Contact for details

Quality Control

Every batch of Sugammadex Impurity 69 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive); therefore, the container should be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

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%
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.