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Fosamprenavir Calcium CAS NO 226700-81-8
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CAS No.:226700-81-8
Grade:Pharmacy Grade
Content:99.9%
Brand:Customizable
Packaging:Customizable
Description
Fosamprenavir Calcium CAS NO 226700-81-8 is the calcium salt of the prodrug fosamprenavir, designed to enhance the oral bioavailability of the active protease inhibitor, amprenavir. This compound is a critical active pharmaceutical ingredient (API) in the global fight against Human Immunodeficiency Virus (HIV) infection. It is primarily required by pharmaceutical manufacturers engaged in the development and production of antiretroviral combination therapies, serving as a cornerstone in treatment regimens for HIV-1.
Application
- Antiretroviral Drug Manufacturing: Primary use as the active pharmaceutical ingredient (API) in the synthesis of fosamprenavir calcium tablets.
- HIV-1 Combination Therapy: A key component in fixed-dose combination (FDC) drugs used for the treatment of HIV-1 infection in adults and pediatric patients.
- Pharmaceutical R&D: Serves as a reference standard and starting material in research for next-generation protease inhibitors and improved drug formulations.
- Generic Drug Production: Essential for manufacturers producing bioequivalent versions of branded antiretroviral medications.
- Clinical Trial Material (CTM): Used in the production of batches for clinical studies investigating new treatment protocols or patient populations.
Basic Information
| Product Name | Fosamprenavir Calcium |
| CAS No. | 226700-81-8 |
| Molecular Formula | C₂₅H₃₄CaN₃O₉PS |
| Molecular Weight | 623.66 g/mol |
| Synonyms | Fosamprenavir Calcium Salt; GW 433908G; (3S)-Tetrahydro-3-furyl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-hydroxypropylcarbamate Sulfate (Ester) Calcium Salt (2:1); Amprenavir Phosphate Ester Calcium Salt; Lexiva API (Calcium Salt); Telzir API (Calcium Salt); Prozei API (Calcium Salt) |
| EINECS | Contact for details |
Quality Control
Our Fosamprenavir Calcium is manufactured under strict quality management systems, targeting compliance with current Good Manufacturing Practices (cGMP) for active pharmaceutical ingredients. Each batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) is provided with every shipment, detailing specifications and results for critical parameters such as purity, related substances, and heavy metals to ensure it meets the stringent requirements of global pharmacopoeial standards.
Storage
Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation. Keep away from incompatible materials.
Specification
| Item | Specification |
|---|---|
| Appearance | White to off-white powder |
| Identification (IR) | Conforms to reference standard |
| Identification (HPLC) | Retention time corresponds to standard |
| Assay (HPLC) | 98.0% - 102.0% (on anhydrous basis) |
| Water Content (KF) | ≤ 5.0% |
| Related Substances (HPLC) | Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0% |
| Residual Solvents (GC) | Complies with ICH Q3C guidelines |
| Heavy Metals | ≤ 20 ppm |
| Microbial Enumeration | Complies with Ph. Eur. 2.6.12 / USP <61> |
Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.
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Each batch undergoes strict QC, accompanied by COA, MSDS, and full compliance with international standards.
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