Description

Sulbactam Impurity 7 is a specified impurity of the β-lactamase inhibitor Sulbactam, identified by the CAS registry number 36091-15-3. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Sulbactam and its related drug substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sulbactam API batches.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels against ICH Q3A/B thresholds.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Sulbactam.

Basic Information

Product Name	Sulbactam Impurity 7
CAS No.	36091-15-3
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 1,1-dioxide derivative; Sulbactam related compound; Sulbactam degradation product; β-lactamase inhibitor impurity.
EINECS	Contact for details

Quality Control

Every batch of Sulbactam Impurity 7 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH and cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	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.