99% up, DMF, FDA (zero defect) Emtricitabine 143491-57-0
Basic Information
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Product Name
99% up, DMF, FDA (zero defect) Emtricitabine 143491-57-0
Substance
Manufacturer(s)
Specifications
- Purity: Assay 98–102% (HPLC grade)
- IUPAC Name: 4-amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one
- EC Number: 604-363-1
- Molecular Weight: 247.25
- Chemical Formula: C8H10FN3O3S
- CAS Number: 143491-57-0
- Certification Standard: USP, BP, EP, JP grade
- Regulatory Status: DMF filed; FDA zero-defect record
- Formulation Type: White to off-white powder (bulk API)
- Quality Standard: 98% up, Medicine Grade
- Appearance: White to off-white powder
- Test: SPECIFICATION
- Identification: By chiral HPLC: the retention time of the main peak corresponds within 2.0% to that of the cis-(-)-EMTB reference standard
- Water content: NMT 0.5%
- Residue on ignition: NMT 0.2%
- Bulk Density: Report data
- Residual solvent: Methanol ≤ 0.20%
- Assay by HPLC: 98.0~102.0 (Dried basis)
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GMP
CEP certificates with DMF documents are available
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