Description

Sulbactam Impurity 2 is a specified impurity of the β-lactamase inhibitor Sulbactam, identified by CAS NO 111790-24-0. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable impurity standards to ensure the safety, efficacy, and regulatory compliance of Sulbactam-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sulbactam Impurity 2 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Sulbactam API and formulations meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry studies by identifying and quantifying this impurity during Sulbactam synthesis.

Basic Information

Product Name	Sulbactam Impurity 2
CAS No.	111790-24-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S,5R)-3,5-Dimethyl-4,4-dioxo-7-oxo-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Penicillanic acid sulfone impurity; Sulbactam related compound; Sulbactam sulfone derivative; 1-Azabicyclo[3.2.0]heptane-2-carboxylic acid, 3,5-dimethyl-4,4,7-trioxo-, (3S,5R)-; Sulbactam Degradant
EINECS	Contact for details

Quality Control

Our Sulbactam Impurity 2 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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