Ubrogepant API Cas No.1374248-77-7

Ubrogepant API Cas No.1374248-77-7

Product Name: Ubrogepant API
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
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Products Description

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Xi'an Tihealth supplies high-quality Ubrogepant Active Pharmaceutical Ingredient (API)

With strict adherence to cGMP and ICH guidelines for quality management. Utilizing advanced synthesis and purification processes, our product consistently achieves a purity level of over 99.5%, with tightly controlled impurity profiles-each individual impurity remains below 0.15%, fully meeting the high standards required by pharmaceutical manufacturers.

The product exhibits stable crystalline structure and excellent solubility, ensuring strong batch-to-batch consistency and providing reliable support for customers' formulation development and production. With a robust quality research system and mature production capacity, we are well-equipped to meet diverse market needs-from clinical development to commercial-stage supply-and are committed to delivering safe, compliant, and efficient API solutions to our clients worldwide.

Products Function

Ubrogepant API is the high-purity active pharmaceutical ingredient used in the formulation and manufacturing of the finished drug product (tablets). It functions as a highly potent and selective antagonist of the human calcitonin gene-related peptide (CGRP) receptor.

Indications:

The drug product manufactured using Ubrogepant API is indicated for the acute treatment of migraine with or without aura in adults. It is not indicated for the prophylactic therapy of migraine.

Mechanism of Action

Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. It works by selectively blocking the binding of the CGRP neuropeptide to its receptors. CGRP is a key mediator involved in the pathophysiology of migraine, as it promotes vasodilation of cranial blood vessels, transmits pain signals, and triggers neurogenic inflammation. By inhibiting the CGRP pathway, Ubrogepant reverses these processes, thereby alleviating migraine pain and associated symptoms.

Products Application

The primary application of Ubrogepant API is in the pharmaceutical manufacturing sector. It is used as the raw material (bulk drug substance) for the production of oral solid dosage forms, specifically:

Film-coated tablets (e.g., 50 mg and 100 mg strengths). Drug product manufacturers will process the API through various stages, including formulation, granulation, mixing, compression, and coating, to produce the final commercial medication ready for patient use.

Pharmacological effects

Therapeutic Effect: Rapid relief from moderate to severe migraine headache pain, as well as associated symptoms such as photophobia, phonophobia, and nausea.

Selectivity: Demonstrates high binding affinity and selectivity for the human CGRP receptor, with minimal activity on other related receptors (e.g., adrenomedullin, amylin receptors), reducing the potential for off-target side effects.

Vascular Effects: Inhibits CGRP-induced vasodilation in cranial arteries without causing vasoconstriction, which differentiates it from older ergotamine and triptan drugs.

Central and Peripheral Effects: Acts both peripherally on the trigeminal nerve system and potentially within the central nervous system to modulate pain pathways.

No Evidence of Abuse: In human studies, Ubrogepant showed no signals indicative of abuse or dependence potential.

 

 

 

 

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