Description

Nafcillin Penilloic Acid (Mixture Of Diastereomers) is a key chemical intermediate and degradation product related to the β-lactam antibiotic nafcillin. This compound is of significant importance for pharmaceutical research and development, particularly in the study of drug stability, metabolism, and impurity profiling. It is primarily required by analytical laboratories, pharmaceutical R&D departments, and quality control units engaged in the development and regulatory compliance of penicillin-based antibiotics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of nafcillin-related impurities in drug substances and finished products.
• Analytical Method Development: Serves as a critical standard in developing and validating HPLC, LC-MS, and other chromatographic methods for antibiotic analysis.
• Stability and Degradation Studies: Employed in forced degradation studies to understand the breakdown pathways and stability profile of nafcillin under various conditions.
• Metabolite Research: Acts as a relevant compound in pharmacokinetic and metabolic studies of nafcillin.
• Quality Control & Assurance: Essential for setting impurity specifications and ensuring batch-to-batch consistency in nafcillin API manufacturing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) concerning impurity identification and control strategies.

Basic Information

Product Name	Nafcillin Penilloic Acid (Mixture Of Diastereomers)
CAS No.	940306-31-0
Molecular Formula	C21H22N2O5S
Molecular Weight	414.48 g/mol
Synonyms	(2S,5R,6R)-6-[(2-Ethoxy-1-naphthoyl)aminomethyl]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Nafcillin Penicilloic Acid; Nafcillin Penilloate; 6-(Naphthalene-2-carboxamido)penicillanic acid derivative; Nafcillin degradation product; β-lactam hydrolysis product of Nafcillin
EINECS	Contact for details

Quality Control

Our Nafcillin Penilloic Acid is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and determination of residual solvents and moisture content to ensure it meets high-purity standards suitable for research and analytical applications. A detailed Certificate of Analysis (COA) is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0% (Area Percent)
Water Content (KF)	≤ 2.0 %
Residual Solvents (GC)	Complies with ICH guidelines

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