Description

Mezlocillin Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic Mezlocillin by serving as a benchmark in impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The availability of this well-characterized impurity is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of the antibiotic Mezlocillin.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and quantification.
• Stability Studies: Employed to identify and monitor degradation products in Mezlocillin drug substance and finished product stability programs.
• Regulatory Compliance & Filings: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Mezlocillin.
• Pharmacopeial Testing: Applied as a system suitability standard in tests prescribed by USP, EP, or other pharmacopeias.

Basic Information

Product Name	Mezlocillin Impurity 3
CAS No.	2250242-54-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mezlocillin Related Compound 3; Mezlocillin EP Impurity C; Mezlocillin USP Impurity; (2S,5R,6R)-6-[[(2R)-2-[[(3S,5S)-5-Methyl-2-oxo-1,3-oxazolidin-3-yl]carbonylamino]-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Mezlocillin Degradant; Mezlocillin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Mezlocillin Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, and relevant USP/EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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