Description

Sugammadex Impurity 16 is a high-purity reference standard used in the pharmaceutical development and quality control of the neuromuscular blockade reversal agent, Sugammadex. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for those working on complex synthetic molecules and injectable formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Sugammadex Impurity 16 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods for impurity profiling of Sugammadex.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity levels against strict ICH Q3A/B guidelines to ensure batch-to-batch consistency and regulatory compliance.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy for the drug substance and product.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Sugammadex synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Sugammadex Impurity 16
CAS No.	2412952-97-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sugammadex Related Compound 16; Bridion Impurity 16; γ-Cyclodextrin, 6A,6B,6C,6D,6E,6F,6G,6H-octakis-S-[(carboxycarbonothioyl)methyl]-6A,6B,6C,6D,6E,6F,6G,6H-octathio-, octasodium salt (Impurity); RO-050-3820 Impurity; Org 25969 Impurity
EINECS	Contact for details

Quality Control

Our Sugammadex Impurity 16 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC, NMR, and MS. We support compliance with ICH Q3A, Q3B, and Q6A guidelines, and our quality commitment aligns with cGMP standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.