Description

Azlocillin Opern-Ring Decarboxylation Impurity is a key chemical reference standard used in the analytical profiling of the antibiotic Azlocillin. This compound is critical for pharmaceutical quality control and research, specifically for identifying and quantifying a major degradation product formed via decarboxylation of the open-ring structure. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, ensuring the purity, safety, and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods for Azlocillin.
• Quality Control (QC) Testing: Used in routine QC labs to monitor and control the level of this specific degradation impurity in Azlocillin API and finished dosage forms.
• Stability Studies: Employed to identify degradation pathways and establish shelf-life specifications for Azlocillin-containing products.
• Regulatory Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing impurity characterization data as per ICH Q3A/B guidelines.
• Research and Development: Used in R&D to study the degradation kinetics and chemical behavior of Azlocillin under various conditions.

Basic Information

Product Name	Azlocillin Opern-Ring Decarboxylation Impurity
CAS No.	99795-14-9
Molecular Formula	C20H23N5O6S
Molecular Weight	461.49 g/mol
Synonyms	(2S,5R,6R)-6-[[(2R)-2-[[(3S,6S)-6-[[(Aminocarbonyl)amino]methyl]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carbonyl]amino]-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid; Azlocillin Open Ring Impurity; Azlocillin Decarboxylated Impurity; Azlocillin Related Compound; Azlocillin Degradation Product
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured under strict quality control conditions. Each batch is characterized and qualified using advanced analytical techniques including NMR, MS, and HPLC to ensure structural identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile. Our quality system is designed to support GMP/GLP compliance for use in regulated pharmaceutical environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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