China Suppliers for tert-butyl(S)-3-amino-2-(4-fluoro-3,5-dimethylphenyl)-4-methyl-2,4,6,7-tetrahydro-5H-pyr Factory
Basic Information
tert-Butyl(S)-3-amino-2-(4-fluoro-3,5-dimethylphenyl)-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-carboxylate is a high-value chiral heterocyclic pharmaceutical intermediate, serving as a key building block for Oglometinib synthesis. Oglometinib, a novel regulatory drug, shows great therapeutic potential in metabolic diseases, and the quality of this intermediate directly determines the efficacy and safety of the target drug.
Physicochemically, it appears as a white to off-white crystalline solid. Its melting and boiling points vary regularly with purity; it has moderate solubility in polar organic solvents such as methanol, ethanol, and dimethyl sulfoxide, but is poorly soluble in water. Fluoro and methyl groups in its molecular structure endow it with good lipophilicity, enhancing reaction compatibility in subsequent drug synthesis and facilitating membrane permeability of the final drug molecule, which meets the needs of pharmaceutical synthesis processes.
Quality control adheres strictly to pharmaceutical standards, with core indicators including purity ≥98% and enantiomeric excess ≥99%. Heavy metals and impurity residues must be tightly controlled to avoid affecting Oglometinib’s synthesis efficiency and product purity. It is purified by column chromatography or recrystallization during production, and finished products are tested by high-performance liquid chromatography (HPLC) to ensure batch consistency, meeting the standardization requirements of large-scale pharmaceutical production.
Storage & Safety: For storage, stability and safety must be prioritized. It should be hermetically stored in a cool, dry, and well-ventilated environment, avoiding moisture, high temperature, and direct strong light, with a recommended storage temperature of 2-8℃. It must be isolated from oxidants, strong acids, and alkalis to prevent structural degradation due to chemical reactions.
Pharmaceutical-grade leak-proof and anti-adsorption containers are used for packaging, and purity is regularly tested during the shelf life to ensure stability in use. It should be stored in vacuum-sealed, moisture-proof and light-proof containers. Operation should be carried out in a fume hood with full protective gear to avoid skin contact and powder inhalation. It is only for pharmaceutical R&D and intermediate synthesis, not for clinical use.
| Item | Unit | Specification |
| Appearance | - | White to off-white crystalline powder |
| Solubility | - | Soluble in methanol, ethanol, and dimethyl sulfoxide; poorly soluble in water. |
| Identification | - | Infrared spectroscopy + HPLC retention time |
| Other impurities | % | ≤0.1 |
| Related Substances - Total Impurities | % | ≤2.0 |
| Main peak purity | % | ≥98.0 |
| Chiral purity | % | ≥99.0 |
| Storage | - | Cool, dry, well-ventilated environment, 2-8℃, avoid light/moisture. |