Description

Sugammadex Impurity 17 is a designated impurity reference standard used in the analytical profiling and quality control of the neuromuscular blockade reversal agent, Sugammadex. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API) and its final drug product. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for qualitative and quantitative analysis in Sugammadex API and formulation testing.
• Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to confirm that impurity levels in production batches are within specified limits per ICH guidelines.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of Sugammadex during synthesis and storage.

Basic Information

Product Name	Sugammadex Impurity 17
CAS No.	2414905-36-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sugammadex Related Compound 17; Bridion Impurity 17; (1R,2R,3S,4S,5R,6S)-6-[(R)-Carboxy(mercapto)methyl]-6-deoxy-per-O-sulfonated-γ-cyclodextrin Impurity; γ-Cyclodextrin, 6-deoxy-6-[(1R)-1-carboxy-2-mercaptoethyl]-, hexakis(hydrogen sulfate), Impurity 17
EINECS	Contact for details

Quality Control

Every batch of Sugammadex Impurity 17 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.