Description

Fidaxomicin Impurity 4 is a specified impurity and degradation product of the macrocyclic antibiotic fidaxomicin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily used by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis, purification, and validation of fidaxomicin-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in fidaxomicin active pharmaceutical ingredient (API) and finished drug products.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, to ensure specificity, accuracy, and precision in impurity profiling.
• Stability Studies: Employed to monitor the formation of degradation products during forced degradation and long-term stability testing of fidaxomicin formulations.
• Quality Control (QC) Testing: A critical component in the routine QC release testing of fidaxomicin batches to confirm they meet pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data for drug approval filings.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Fidaxomicin Impurity 4
CAS No.	106008-69-9
Molecular Formula	C52H74Cl2O18
Molecular Weight	1042.0 g/mol
Synonyms	Tiacumicin B; LFF 571 Impurity; Lipiarmycin A3 Impurity; Clostomicin B1; Dificid Impurity 4; OPT-80 Impurity; PAR-101 Impurity; (3R,4S,5S,6R,8R,9S,10E,12E,15S,16R,19S)-19-[(2S,3S,4S,5S,6R)-4,5-Dihydroxy-3,6-dimethyl-2-oxanyl]-16-ethyl-3,4,5,9,15-pentahydroxy-8,10,12-trimethyl-6-[[(4S,5S)-5-[(1R)-1-hydroxyethyl]-4-methyl-2-oxo-3-oxolanyl]oxy]-1-oxacyclohexadeca-10,12-diene-7,13,17-trione
EINECS	Contact for details

Quality Control

Our Fidaxomicin Impurity 4 is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, and is supplied with a comprehensive Certificate of Analysis (COA). The COA provides detailed data on identity, purity, and impurity profile, supporting its use as a reference standard in GMP/GLP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below under inert atmosphere. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent moisture condensation. The material should be handled in a controlled environment to maintain its integrity as a reference standard.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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