Description

Flucloxacillin Sodium Impurity A is a specified impurity and degradation product of the antibiotic Flucloxacillin Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Flucloxacillin Sodium API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Flucloxacillin Sodium bulk drug and formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to establish specificity, accuracy, and detection limits for impurity profiling methods in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Critical for routine quality assurance testing of active pharmaceutical ingredients (APIs) to ensure compliance with pharmacopeial monographs (e.g., USP, EP, BP).
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to determine product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to agencies like the FDA and EMA.
• Research on Degradation Pathways: Facilitates studies into the chemical stability and decomposition mechanisms of Flucloxacillin Sodium.

Basic Information

Product Name	Flucloxacillin Sodium Impurity A
CAS No.	68728-50-7
Molecular Formula	C19H16ClFN3NaO5S
Molecular Weight	475.86 g/mol
Synonyms	(2S,5R,6R)-6-[[[3-(2-Chloro-6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt; Flucloxacillin Impurity A; Flucloxacillin Related Compound A; Sodium (2S,5R,6R)-6-[[[3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Flucloxacillin Sodium Impurity A is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and mass spectrometry to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use as a reference standard in regulated 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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 1.0%

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