Description

Sugammadex Impurity 19 CAS NO 2379877-89-9 is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the neuromuscular blockade reversal agent, Sugammadex. It is primarily required by analytical chemists, quality assurance (QA) professionals, and research scientists working in pharmaceutical development and regulatory compliance. Ensuring the identity and purity of this impurity is essential for meeting stringent pharmacopeial standards and ensuring drug safety and efficacy.

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, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in GMP manufacturing environments.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of Sugammadex.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to agencies like the FDA and EMA.
• Research & Development: Used in metabolic studies, degradation pathway elucidation, and impurity synthesis research.

Basic Information

Product Name	Sugammadex Impurity 19
CAS No.	2379877-89-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sugammadex Related Compound 19; Bridion Impurity 19; (S)-γ-Cyclodextrin derivative impurity; 6-Per-deoxy-6-per-(2-carboxyethyl)thio-γ-cyclodextrin impurity; Org 25969 Impurity; RO-109-2022-001 Impurity; Rocuronium reversal agent impurity
EINECS	Contact for details

Quality Control

Our Sugammadex Impurity 19 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with ICH Q3A/B guidelines and current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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