First-in-class ACL inhibitor API for non-statin lipid management formulations. ComWin supplies high-purity Bempedoic Acid suitable for oral solid dosage manufacturing, backed by rigorous quality control.
Bempedoic Acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor. It is a prodrug requiring activation in the liver, designed to lower LDL-C levels through a non-statin mechanism, offering a unique profile for formulation development.
| Chemical Name | Bempedoic Acid |
| CAS Number | 738606-46-7 |
| Molecular Formula | C19H36O5 |
| Molecular Weight | 344.49 |
| Molecular Structure |  |
| Packing | 25KG/Drum |
| Shelf-life | Three years |
| Storage Condition | Stored in an airtight container, at a temperature not more than 25℃ |
| Application | Lowers LDL cholesterol, Treats hypercholesterolemia, Adjunct to statin therapy, For statin-intolerant patients, Reduces cardiovascular risk |
| Items | Specifications |
| Appearance | White to almost white crystalline powder |
| Identification (IR) | Infrared absorption spectrum is consistent with the reference substance |
| Identification (HPLC) | The retention time of major peak from sample solution corresponds to that from standard solution, as obtained in the assay test. |
| Water Content | ≤ 0.5% |
| Chlorides | ≤ 0.02% |
| Residue on Ignition | For information only |
| Heavy Metals | ≤ 10ppm |
| Related Substances | BPD-4≤ 0.10% |
| IP-BPD-3≤ 0.10% | |
| IP-BPD-4≤ 0.10% | |
| IP-BPD-6≤ 0.10% | |
| Unspecified Impurities≤ 0.10% | |
| Total Impurities≤ 0.50% | |
| Residual Solvents 1 | Methanol≤ 0.3% |
| Ethanol≤ 0.5% | |
| Acetonitrile≤ 0.041% | |
| Dichloromethane≤ 0.06% | |
| Isopropyl Acetate≤ 0.5% | |
| Tert-Butylmethyl Ether≤ 0.5% | |
| N-Heptane≤ 0.5% | |
| Residual Solvents 2 | Dimethyl Sulfoxide≤ 0.5% |
| Residual Solvents 3 | Benzene≤ 2ppm |
| Genotoxic-Impurities | Chloroethane≤ 8.4ppm |
| Particle Size (D90) | 30μm ~ 60μm |
| Microbiological Quality | TAMC≤ 1000cfu/g |
| TVMC≤ 100cfu/g | |
| Escherichia Coli : Absent in 1g | |
| Assay | 98.0%~102.0% (calculated to the anhydrous substance) |
| 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.
Active ingredient for the manufacturing of immediate-release tablets.
Compatible for processing into fixed-dose combinations with Ezetimibe.
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