Ubrogepant API Cas No.1374248-77-7
Product Origin: Fully Synthetic
Specification: ≥99.0%
CAS No.: 1374248-77-7
Molecular Formula: C₂₉H₂₆F₃N₅O₃
Molecular Weight: 549.55 g/mol
Testing Method: HPLC
Active Ingredient: Ubrogepant
Product Characteristics: White to off-white crystalline powder
Solubility: Product Packaging: 1kg/bag; 25kg/drum
Storage Conditions: Protect from light; store sealed. Refrigerate at 2-8°C in darkness. Upon opening, use promptly in a dry environment and reseal with nitrogen flush.
Shelf Life: 24 months
Ubrogepant API Powder CAS 1374248-77-7
Why Is Ubrogepant Essential For Non-Vasoconstrictive Migraine Formulations?
1. API Characterization & Manufacturing Value
Xi'an Tihealth supplies pharmaceutical-grade Ubrogepant API (CAS 1374248-77-7), a potent, orally bioavailable small-molecule Calcitonin Gene-Related Peptide (CGRP) receptor antagonist. Representing a paradigm shift in the acute treatment of migraine, Ubrogepant effectively aborts migraine attacks without inducing the coronary or peripheral vasoconstriction commonly associated with traditional triptans (5-HT1B/1D agonists), making it an indispensable active ingredient for patients with cardiovascular contraindications.
The synthesis of Ubrogepant is highly complex due to its multiple chiral centers. Manufactured under strict cGMP protocols, our fully synthetic API undergoes advanced asymmetric synthesis and chiral HPLC purification to guarantee an enantiomeric excess (ee) >99.5% of the active (3'R, 6'S) isomer. Engineered with a stable crystalline profile and optimized Particle Size Distribution (PSD), our powder ensures rapid dissolution kinetics crucial for immediate-release oral solid dosage formulations.
2. Technical Data Sheet (TDS) & Specifications
| Quality Parameter | Specification Limit (In-House / EP / USP) |
|---|---|
| Physical Appearance | White to off-white crystalline powder |
| Assay (HPLC, Anhydrous Basis) | ≥ 99.5% |
| Chiral Purity (Enantiomeric Excess, ee) | ≥ 99.5% (Strictly controlled active isomer) |
| Related Substances (HPLC) | Single Unknown Impurity ≤ 0.10%; Total Impurities ≤ 0.50% |
| Particle Size Distribution (PSD) | Optimized D50 / D90 values for rapid oral dissolution |
| Loss on Drying | ≤ 0.5% |
| Heavy Metals (ICP-MS) | ≤ 10 ppm (Compliant with ICH Q3D limits) |
3. Pharmacodynamics & CGRP Antagonism
Selective Receptor Blockade
Ubrogepant acts as a highly selective, competitive antagonist at the human CGRP receptor complex located on trigeminal nerve endings. By occupying this receptor, it effectively blocks the binding of the CGRP neuropeptide, halting the initiation of neurogenic inflammation and downstream pain signaling cascades.
Non-Vasoconstrictive Action
Unlike conventional migraine therapies, Ubrogepant inhibits CGRP-induced vasodilation of intracranial blood vessels to alleviate headache pain without constricting the vessels themselves. This unique pathway ensures it does not cause coronary or peripheral vasoconstriction.
Trigeminal System Modulation
By neutralizing CGRP activity, it rapidly reduces the sensitization of the trigeminal pain pathway. This mechanism not only aborts the acute headache but also provides prompt relief from debilitating associated symptoms, including photophobia, phonophobia, and nausea.
4. Core Pharmaceutical Applications
- Acute Migraine Formulation: Serves as the primary active pharmaceutical ingredient for manufacturing 50 mg and 100 mg immediate-release film-coated tablets indicated for the acute treatment of migraine with or without aura in adults.
- Generic Drug Development: High-purity, chiral-verified starting material for pharmaceutical developers targeting bioequivalent versions of next-generation oral GEPANT therapeutics.
- Clinical & Neurological Research: Utilized as an essential reference compound in laboratory studies investigating CGRP pathway kinetics and neurogenic inflammation modulation.
CRITICAL COMPLIANCE & HANDLING DIRECTIVE
Intended strictly for B2B industrial pharmaceutical manufacturing, GMP compounding, and authorized R&D applications. Ubrogepant is highly sensitive to moisture and oxidative degradation. To prevent polymorphic phase transitions and maintain chiral integrity throughout its 24-month shelf life, strict storage at 2°C to 8°C in a nitrogen-flushed, airtight environment is mandatory.
5. Frequently Asked Sourcing Questions
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