Description

Sugammadex Impurity 9 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the neuromuscular blockade reversal agent, Sugammadex, by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals working within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Sugammadex.
• Method Development and Validation: Critical for developing and validating robust HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC testing of active pharmaceutical ingredients (APIs) and finished drug products to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products in stability-indicating assay methods.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Optimization: Helps chemists identify and minimize the formation of this specific impurity during the synthesis and purification of Sugammadex.

Basic Information

Product Name	Sugammadex Impurity 9
CAS No.	1393112-40-7
Molecular Formula	C72H104Na8O48S8
Molecular Weight	2178.0 g/mol (Free acid form)
Synonyms	Bridion Impurity 9; γ-Cyclodextrin, 6A,6B,6C,6D,6E,6F,6G,6H-octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-, octasodium salt; Org 25969 Impurity 9; Sugammadex Related Compound 9; 6-Per-deoxy-6-per-(2-carboxyethyl)thio-γ-cyclodextrin octasodium salt
EINECS	Contact for details

Quality Control

Every batch of Sugammadex Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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. The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment.

Specification

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