Description

Sulbactam Impurity 6 is a specified impurity and reference standard used in the analytical profiling and quality control of Sulbactam, a β-lactamase inhibitor. 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 required by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Sulbactam Impurity 6 in Sulbactam active pharmaceutical ingredient (API).
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure Sulbactam batches meet pharmacopeial (e.g., USP, EP) or internal specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (heat, light, humidity) as part of ICH stability protocols.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to support drug approval.
• Research on Degradation Pathways: Used in research settings to study the chemical behavior and degradation mechanisms of Sulbactam.

Basic Information

Product Name	Sulbactam Impurity 6
CAS No.	4888-97-5
Molecular Formula	C8H11NO5S
Molecular Weight	233.24 g/mol
Synonyms	(2S,5R)-3,3-Dimethyl-4,4,7-trioxo-4λ6-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid; Penicillanic Acid S,S-Dioxide; Sulbactam S,S-Dioxide; 3,3-Dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid 4,4-Dioxide; Sulbactam Related Compound B; Sulbactam Sulfone
EINECS	Contact for details

Quality Control

Our Sulbactam Impurity 6 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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.