Description

Nafcillin Impurity CAS NO 57628-08-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Nafcillin sodium. It is primarily utilized by pharmaceutical manufacturers, quality control laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Nafcillin sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of Nafcillin to ensure batches meet stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification in drug dossiers.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Nafcillin formulations under various storage conditions.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and chemical behavior of Nafcillin.

Basic Information

Item	Detail
Product Name	Nafcillin Impurity
CAS No.	57628-08-7
Molecular Formula	C21H22N2O5S
Molecular Weight	414.48 g/mol
Synonyms	(2S,5R,6R)-6-[[(2-Ethoxy-1-naphthoyl)amino]methyl]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Nafcillin Related Compound; Nafcillin EP Impurity; Nafcillin USP Impurity; 6-(2-Ethoxy-1-naphthamido)penicillanic acid; Nafcillin Acid
EINECS	Contact for details

Quality Control

Every batch of Nafcillin Impurity CAS NO 57628-08-7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single 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.