Description

Mono Oxidation Sugammadex (Org199425-1) is a key intermediate and impurity reference standard in the synthesis and quality control of Sugammadex sodium, a modified γ-cyclodextrin used as a selective relaxant binding agent. This compound is critical for pharmaceutical research and development, enabling precise analytical method development and ensuring the purity and safety of the final active pharmaceutical ingredient. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in neuromuscular blockade reversal agent production and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC and LC-MS analysis in the quality control of Sugammadex sodium API.
• Process Chemistry Research: Serves as a critical intermediate for studying and optimizing the synthesis pathway of Sugammadex.
• Analytical Method Development: Essential for developing and validating stability-indicating methods to monitor degradation products in drug formulations.
• Regulatory Compliance & Filings: Supports the characterization and control of impurities as required by ICH guidelines for regulatory submissions (e.g., FDA, EMA).
• Pharmacological Studies: Used in research to understand the metabolism and degradation profile of Sugammadex.

Basic Information

Product Name	Mono Oxidation Sugammadex (Org199425-1)
CAS No.	2412953-14-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Org 199425-1; ORG199425-1; Sugammadex Oxidation Impurity; Sugammadex Mono-Oxidized Derivative; 6-Per-Deoxy-6-Per-(2-carboxyethyl)thio-γ-cyclodextrin Oxidation Product; γ-Cyclodextrin, 6A,6B,6C,6D,6E,6F,6G,6H-octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-, mono-oxide
EINECS	Contact for details

Quality Control

Every batch of Mono Oxidation Sugammadex (Org199425-1) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material under inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms
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%

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