Description

Sulbactam Impurity 2 Sodium Salt is a high-purity reference standard critical for analytical and regulatory purposes in pharmaceutical development. This compound serves as a key impurity marker for ensuring the quality, safety, and efficacy of the β-lactamase inhibitor Sulbactam and its formulations. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method validation, stability studies, and regulatory compliance for antibiotic products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Sulbactam Impurity 2 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurity profiles during stability testing and release.
• Quality Control & Assurance (QC/QA): Critical for routine batch analysis to ensure Sulbactam drug substances and products meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data for drug approval processes.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry and metabolic studies to understand the degradation pathways and chemistry of Sulbactam.

Basic Information

Product Name	Sulbactam Impurity 2 Sodium Salt
CAS No.	4027-62-7
Molecular Formula	C8H10NNaO5S
Molecular Weight	255.22 g/mol
Synonyms	(2S,5R)-3,3-Dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide sodium salt; Penicillanic acid sulfone sodium salt impurity; Sodium (2S,5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide; Sulbactam sodium impurity B; Sulbactam related compound B sodium salt; CP-45,899-2 sodium salt; Betamaze impurity 2 sodium salt
EINECS	Contact for details

Quality Control

Our Sulbactam Impurity 2 Sodium Salt is manufactured under controlled conditions and undergoes rigorous quality testing to ensure high purity and consistency suitable for use as a reference standard. Each batch is characterized using advanced analytical techniques including HPLC, NMR, and mass spectrometry. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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