Description

Fusidic Acid Impurity 1 is a specified impurity of the antibiotic Fusidic Acid, identified by the CAS registry number 14424-54-5. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities in Fusidic Acid drug substances and finished products. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting compliance with stringent regulatory guidelines for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Fusidic Acid.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in-house by manufacturers to monitor and control the impurity levels in Fusidic Acid batches to meet pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Employed to track the formation of this specific impurity over time under various storage conditions.
• Research & Development: Supports studies on the degradation pathways and chemical behavior of Fusidic Acid.

Basic Information

Product Name	Fusidic Acid Impurity 1
CAS No.	14424-54-5
Molecular Formula	C31H48O6
Molecular Weight	516.71 g/mol
Synonyms	3-Ketofusidic Acid; 3-Oxofusidic Acid; 16α-Acetoxy-3,11-dioxo-4β,8α,9β,14α-tetraacetoxyfusida-17(20),24-dien-21-oic Acid; Fusidic Acid Impurity A; Fusidic Acid Related Compound A; (2Z)-2-[(3S,4S,5S,8R,9S,10S,11S,13R,14S,16R,17R)-16-(Acetyloxy)-3,11-dihydroxy-4,8,10,14-tetramethyl-5,9-dioxo-17-[(2R,3R)-3-[(2S,3S,4R)-3,4-dimethyloxolan-2-yl]oxiran-2-yl]-2-oxatricyclo[11.3.1.14,8]heptadecan-13-yl]-2-methylbut-2-enoic Acid
EINECS	Contact for details

Quality Control

Every batch of Fusidic Acid Impurity 1 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment supports your needs for reliable reference standards in GMP/GLP 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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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