Description

Fusidic Acid Bp Impurity L is a specified impurity of the antibiotic Fusidic Acid, as defined by the British Pharmacopoeia (BP) standards. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes to ensure drug safety and efficacy. It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance testing of Fusidic Acid-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Fusidic Acid BP Impurity L in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, used in impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopoeial specifications (BP, EP, USP).
• Stability Studies: Employed to track the formation and increase of this specific degradation product over time under various storage conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Fusidic Acid.

Basic Information

Product Name	Fusidic Acid Bp Impurity L
CAS No.	74048-41-2
Molecular Formula	C31H48O6
Molecular Weight	516.72 g/mol
Synonyms	3-Ketofusidic Acid; 3-Oxofusidic Acid; Fusidic Acid Impurity L (BP); (2Z)-2-[(3S,4R,5S,8R,9S,10S,11S,13R,14S,16R,17R)-3,11-Dihydroxy-4,10,13-trimethyl-17-[(2R)-6-methylhept-5-en-2-yl]-2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17-hexadecahydro-1H-cyclopenta[a]phenanthren-16-yl]-5-methylidenehept-2-enedioic acid
EINECS	Contact for details

Quality Control

Our Fusidic Acid BP Impurity L is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR), to ensure it meets the stringent requirements for a pharmacopoeial impurity standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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)	Individual 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.