Description

Sulbactam Impurity 8 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the β-lactamase inhibitor Sulbactam and its pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance. The availability of this well-characterized impurity is essential for method validation and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sulbactam Active Pharmaceutical Ingredient (API) batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure analytical procedures remain accurate and precise.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of this specific degradant in Sulbactam drug substances and products under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to study degradation pathways and to synthesize impurity-free final products.

Basic Information

Item	Details
Product Name	Sulbactam Impurity 8
CAS No.	75527-88-7
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 degradant; Sulbactam impurity; 3,3-Dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide; Penicillanic acid sulfone impurity
EINECS	Contact for details

Quality Control

Every batch of Sulbactam Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified criteria.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.