[Specification]
TEST ITEM
|
ACCEPTANCE CRITERIA
|
APPEARANCE
|
PALE YELLOW SOLID
|
SOLUBILITY
|
SPARINGLY SOLUBLE IN DMF, Acetonitirle
SLIGHTLY SOLUBLE IN DMSO
INSOLUBLE IN Methanol, Ethanol, Ether, Water and Buffer
|
IDENTIFICATION (FT-IR)
|
CONFORMS TO STRUCTURE
|
IDENTIFICATION (1H-NMR)
|
CONFORMS TO STRUCTURE
|
IDENTIFICATION (ESI-MS)
|
m/z, 701 [M+H]+
|
ISOMER RATIO (1H-NMR)
|
47 : 53 ± 5%
|
PURITY (HPLC)
|
≥ 98%
|
ENDOTOXIN
|
≤ 175 EU/mL
|
RESIDUAL SOLVENTS (GC)
- Methanol
- Ethyl acetate
- Hexane
- Dichloromethane
- Tetrahydrofuran
|
NMT 3,000 ppm
NMT 5,000 ppm
NMT 290 ppm
NMT 600 ppm
NMT 720 ppm
|
We certified that the company FutureChem has been duly authorized to manufacture API.
[REFERENCE]
1. Su Yeon Park, Dae Yoon Chi et al. The correlation
of neuropsychological evaluation with 11C-PiB and 18F-FC119S amyloid PET in
mild cognitive imparment and Alzheimer disease, Medicine, 2020, 99,
e19620.
2. Inki Lee et al. Clinical Usefulness of 18F-FC119S
Positron-Emission Tomography as an Auxiliary Diagnostic Method for Dementia: An
Open-Label, Single-Dose, Evaluator-Blind Clinical Trial, J Clin Neurol, 2020,
16, 131-139.
3. Byn BH et al. Head-to-head comparison of 11C-PiB
and 18F-FC119S for Aβ imaging in healthy subjects, mild cognitive impairment
patients, and Alzheimer's disease patients., Medicine (Baltimore), 2017,
96(12), e6441.
4. Se Jong Oh, Dae Yoon Chi et al. Preliminary PET
Study of 18F-FC119S in Normal and Alzheimer’s Disease Models, Mol.
Pharmaceutics, 2017, 14, 3114-3120.