Description

Sugammadex Impurity 26 (Org199129-1) is a high-purity reference standard and a critical process-related impurity in the synthesis of Sugammadex sodium. This compound is essential for pharmaceutical research and development, specifically for method development, validation, and quality control of the active pharmaceutical ingredient (API). It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Sugammadex sodium.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor and control impurity profiles.
• Quality Control & Assurance: Employed in routine batch testing to confirm the identity and limit of this specific impurity, ensuring API meets ICH guidelines.
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and shelf-life studies of the drug substance.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Sugammadex to minimize the formation of this impurity.

Basic Information

Product Name	Sugammadex Impurity 26 (Org199129-1)
CAS No.	2412953-06-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Org199129-1; Sugammadex Related Compound 26; (1R,2R,3S,4S,5R,6S)-4-[(R)-Carboxy(mercapto)methyl]-3,5,12-trihydroxy-3,4,5,6,11,12-hexahydro-1,2-cyclobuta[1,2]dibenzeno[5,6]cycloocta[1,2,3-cd]inden-8-yl β-D-Glucopyranosiduronic Acid (putative); Sugammadex Impurity O; Bridion Impurity 26
EINECS	Contact for details

Quality Control

Every batch of Sugammadex Impurity 26 (Org199129-1) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	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% w/w

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