Description

Sulbactam Impurity 10 is a designated reference standard used in the analytical profiling and quality control of the β-lactamase inhibitor, Sulbactam. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Sulbactam-based drug substances and finished products. It is primarily utilized in research and development, method validation, and regulatory compliance activities within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Sulbactam Sodium API and its formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Sulbactam products meet pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Aids in studying the chemical stability and decomposition mechanisms of Sulbactam.

Basic Information

Product Name	Sulbactam Impurity 10
CAS No.	91922-15-5
Molecular Formula	C8H11NO5S
Molecular Weight	233.24 g/mol
Synonyms	(2S,5R)-3,3-Dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide; Penicillanic acid sulfone derivative; Sulbactam related compound; Sulbactam impurity B; Sulbactam degradation product; 3,3-Dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide
EINECS	Contact for details

Quality Control

Every batch of Sulbactam Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with industry standards. 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) or as indicated on the label. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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