A narrow-spectrum macrocyclic antibiotic API. ComWin provides high-assay Fidaxomicin for the production of specialized oral medications targeting C. difficile infections.
Fidaxomicin is a fermentation-derived macrolide antibiotic. It exhibits a unique mechanism of action by inhibiting bacterial RNA polymerase, characterized by minimal systemic absorption, making it ideal for gastrointestinal-targeted formulations.
| Chemical Name | Fidaxomicin |
| CAS Number | 873857-62-6 |
| Molecular Formula | C52H74Cl2O18 |
| Molecular Weight | 1058.04 |
| Molecular Structure |  |
| Packing | As Requested |
| Shelf-life | Two years |
| Storage Condition | Preserve in a tight container and store at 2-8℃. |
| Application | Clostridium difficile infection treatment, Antibiotic-associated diarrhea therapy，GI infection management |
| Items | Specifications |
| Appearance | White to off-white powder |
| Identification | By HPLC: The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. |
| By IR: The IR spectrum of test sample should corresponds to that of reference standard. | |
| Clarity of Solution | Colorless, transparent liquid if there is a color, it must not be darker than the yellow No.1. |
| Related Substances | Impurity A ≤ 0.1% |
| Impurity B ≤ 0.1% | |
| Impurity at RRT1.33 ≤ 0.1% | |
| Any other individual impurity ≤ 0.15% | |
| Total impurities ≤ 0.1% | |
| Acetaldehyde | ≤ 0.038% |
| Methy Alcohol | ≤ 0.3% |
| Acetonitrile | ≤ 0.041% |
| Ethanol | ≤ 0.5% |
| Ethyl Acetate | ≤ 0.5% |
| n-hexane | ≤ 0.029% |
| Acetic Acid | ≤ 0.5% |
| Water (K.F) | ≤ 2.0% |
| Lgnited Residue | ≤ 0.1% |
| Heavy Metals | ≤ 10ppm |
| Partical Size | D90≤ 150um |
| Assay (on the anhydrous basis) | 98.0~102.0% |
| Microbial limit | TAMC ≤10,00CFU/g |
| TYMC ≤100CFU/g | |
| E-Coli: Should be absent | |
| Standard | In-house Standard |
* The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The users are suggested to select the suitability of the products and methods of application.
Used exclusively for manufacturing film-coated tablets for GI tract infections.
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