Product Overview
Mirabegron API is a synthetic, small-molecule ingredient. It is made to meet global quality standards.
It comes as a pure crystalline powder with precise specifications and stable quality.
This helps make efficient formulations.
Therapeutic Applications
Mirabegron API is used for developing regulated drug formulations.
It helps create solid oral dosage forms, like extended-release products.
The API supports single-ingredient and combination formulations.
Its steady quality, purity, and stability make it ideal for commercial use. It works well for scaling up and meeting global rules.
Specification Parameters
These parameters show the main quality measures for Mirabegron API. They also outline the controls used in production.
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Chemical Name : (R)-2-(2-Aminothiazol-4-yl)-N-[4-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]phenyl]acetamide
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CAS Number: 223673-61-8
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Molecular Formula: C₂₁H₂₄N₄O₂S
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Molecular Weight: 396.51 g/mol
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Appearance: White to off-white crystalline powder
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Identification Tests: IR spectroscopy, HPLC retention time comparison
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Assay Method: HPLC (validated method)
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Assay Limits: Typically 98.0%–105.0% on a dried basis
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Related Substances / Impurities: Controlled as per pharmacopeial or in-house limits.
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Residual Solvents: Within ICH Q3C limits
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Elemental Impurities: Complies with ICH Q3D guidelines.
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Loss on Drying / Water Content: Controlled to specified limits.
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Microbial Limits: Meets pharmacopeial standards (or N/A for non-sterile APIs).
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Polymorphic Form: This is required for consistent quality and performance
Packaging & Storage
Mirabegron API is packed in secure, clean HDPE or fiber drums.
These strong drums have inner liners for added protection and safety.
Drums should be sealed up tight to keep moisture and dust out.
For the Mirabegron API, keep it in a dry place. Avoid heat and humidity.
Why Choose Us
As an experienced API manufacturer, Actiza Industry is a trusted global supplier of Mirabegron API.
We offer high-quality manufacturing and dependable global supply chains.
Quality Focus
Our Mirabegron API is high-quality and meets international standards, such as those of the World Health Organisation and the International Organisation for Standardisation.
We also check each batch for quality, focusing on global purity and stability requirements.
Global Reach
We also act as an important vendor for Mirabegron API and cater to Asia Pacific, Latin America, the Middle East, Africa, and CIS.
We have an effective logistics system, hence ensuring that all orders from all over the globe reach them on time.
Integrated Services
Actiza Industry provides complete support for its clients.
We manage everything, including manufacturing, documentation, packaging, storage, and export services.
Customer Support
Our team focuses on ease of communication, flexible ordering, and speedy support, even when they are in different time zones.
This enables teams to collaborate more conveniently. It also creates a strong and lasting relationship for businesses.
