Description

Mezlocillin Sodium Impurity CAS NO 42057-28-3 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and validation of the antibiotic Mezlocillin Sodium, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and biotechnology industries for method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Mezlocillin Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate detection and measurement limits.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies of Mezlocillin Sodium to monitor impurity formation over time and under various stress conditions.
• Quality Control and Batch Release Testing: Acts as a system suitability standard and a quantitative calibrant in the routine QC testing of pharmaceutical batches to ensure they meet stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate control of the manufacturing process.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Mezlocillin Sodium, supporting improved formulation and storage strategies.

Basic Information

Product Name	Mezlocillin Sodium Impurity
CAS No.	42057-28-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[[(2R)-2-[[(3S,5S)-5-methyl-2-oxo-1,3-oxazolidin-3-yl]carbonylamino]-2-phenylacetyl]amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Mezlocillin Related Compound; Mezlocillin Impurity; 42057-28-3; Mezlocillin Sodium EP Impurity; Mezlocillin Sodium USP Impurity
EINECS	Contact for details

Quality Control

Our Mezlocillin Sodium Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous 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. Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, purity, and related substances.

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to Off-white Powder
Identification (IR)	Conforms to Reference Standard
Identification (HPLC)	Retention time matches CRM
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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