Description

Mezlocillinsodium/Sulbactamsodium Impurity 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 related antibiotic formulations in pharmaceutical development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies for method validation, impurity profiling, and batch release testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify and quantify this specific impurity in Mezlocillin Sodium and Sulbactam Sodium drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed in forced degradation and shelf-life studies to monitor the formation of this impurity over time under various stress conditions.
• Regulatory Compliance and Submissions: Essential for preparing impurity identification reports and documentation required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Quality Control Testing: Used in routine batch analysis to ensure that antibiotic active pharmaceutical ingredients (APIs) meet stringent pharmacopeial specifications (e.g., USP, EP).
• Research and Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of β-lactam antibiotics.

Basic Information

Product Name	Mezlocillinsodium/Sulbactamsodium Impurity
CAS No.	790159-66-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mezlocillin Sulbactam Impurity; Impurity of Mezlocillin Sodium and Sulbactam Sodium; 790159-66-9; Mezlocillin/Sulbactam Related Compound; β-lactam Antibiotic Impurity; Mezlocillin Sulbactam Degradation Product; Pharmaceutical Reference Standard
EINECS	Contact for details

Quality Control

Our Mezlocillinsodium/Sulbactamsodium Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and traceability 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified 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.