98.5% up by HPLC Sitagliptin Phosphate 654671-78-0/ 654671-77-9
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98.5% up by HPLC Sitagliptin Phosphate 654671-78-0/ 654671-77-9
Substance
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Specifications
- Purity: ≥98.5% purity (HPLC)
- IUPAC Name: (3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one;phosphoric acid;hydrate
- EC Number: 682-492-2
- Molecular Weight: 523.32
- Chemical Formula: C16H20F6N5O6P
- CAS Number: 654671-78-0
- Certification Standard: USP, BP, EP, JP grade
- Formulation Type: White to off-white crystalline powder (bulk API)
- Quality Standard: 98.5% up by HPLC
- Appearance: White or off-white crystalline powder
- Identification: A. Sitagliptin phosphate in water display discriminate reaction of phosphate. B. HPLC: RRT test solution is similar to RRT reference solution. C. IR: Similar to Reference Substance
- Related substance: XG-E ≤0.15%
- Total impurities ≤0.5%: 0.01%
- Isomer: XG-A ≤0.15%
- Water: 3.0%~4.5%
- Residual Solvents: Isopropyl alcohol ≤0.5%
- Heavy Metals: ≤ 10ppm
- Assay: ≥98.5% on anhydrous basis
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CEP certificates with DMF documents are available
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