0102030405
t-butyl(S)-3-amino-2-(4-fluoro-3,5-dimethylphenyl)-4-methyl-2,4,6,7-tetrahydro-5H-pyr from China Suppliers - Quality Factory Production
Basic Information
Product Description
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.
![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 structure](https://ecdn6-nc.globalso.com/upload/p/4509/image_other/2026-05/d8b062f3-4cb5-47b0-aa9f-a7568ad48ca1.png)
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.
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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.
✅ Purity ≥98%
✅ Chiral Purity ≥99%
✅ HPLC Verified
✅ Pharmaceutical Grade
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℃.
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Temperature
Recommended storage at 2–8℃ in a cool, dry environment.
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Moisture & Light
Avoid moisture, high temperature, and direct strong light exposure.
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Packaging
Vacuum-sealed, moisture-proof and light-proof pharmaceutical-grade containers.
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Chemical Isolation
Must be isolated from oxidants, strong acids, and alkalis to prevent structural degradation.
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Safety Notice: It should be stored in vacuum-sealed, moisture-proof and light-proof containers at 2–8℃ for long-term storage. 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.
Product Specification
| 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; avoid moisture, high temperature, and direct strong light; recommended temperature: 2–8℃ |
Frequently Asked Questions (FAQ)
❓ What is 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 used for?
It is a high-value chiral heterocyclic pharmaceutical intermediate primarily used as a key building block in the synthesis of Oglometinib, a novel drug with significant therapeutic potential in metabolic diseases. It is intended for pharmaceutical R&D and intermediate synthesis only.
❓ What purity standards does this intermediate meet?
This intermediate adheres to strict pharmaceutical-grade quality control standards. The main peak purity is ≥98.0% and chiral purity (enantiomeric excess) is ≥99.0%, as verified by high-performance liquid chromatography (HPLC). Total related substance impurities are controlled to ≤2.0% and other individual impurities to ≤0.1%.
❓ What are the recommended storage conditions for this compound?
The compound should be stored in vacuum-sealed, moisture-proof, and light-proof pharmaceutical-grade containers at a temperature of 2–8℃. It must be kept away from moisture, high temperatures, direct strong light, oxidants, strong acids, and alkalis to prevent structural degradation and maintain stability throughout its shelf life.
❓ How is the purity and quality of this intermediate tested and ensured?
The product undergoes rigorous purification via column chromatography or recrystallization during production. Finished products are tested by HPLC to confirm purity and batch consistency. Identification is further confirmed using infrared spectroscopy combined with HPLC retention time analysis. Purity is also regularly tested during the shelf life to ensure stability.
❓ What solubility properties does this compound exhibit?
The compound shows moderate solubility in polar organic solvents including methanol, ethanol, and dimethyl sulfoxide (DMSO). It is poorly soluble in water. The presence of fluoro and methyl groups in its molecular structure provides good lipophilicity, which enhances reaction compatibility in drug synthesis and supports membrane permeability of the final drug molecule.
❓ What safety precautions should be observed when handling this intermediate?
All operations with this compound must be conducted in a fume hood with full personal protective equipment (PPE), including gloves, lab coat, and eye protection, to prevent skin contact and powder inhalation. The compound must be isolated from oxidants, strong acids, and strong alkalis. It is strictly for pharmaceutical R&D and intermediate synthesis purposes and is not intended for clinical or direct human use.