Mirabegron API

Product Overview

Mirabegron API is the top-quality active ingredient for pharmaceutical products.

It is made under strict quality standards to ensure purity, potency, and stability.

The API is useful for formulating, scaling up, and getting approval from global regulators.

Hence, it is a reliable option for the pharmaceutical research and commercial sectors to work with.

Mirabegron API is used to make drug formulations that need a selective beta-3 adrenergic agonist.

It aids in formulation work, enhances process improvement, and assists with scale-up activities.

The API is used in research, quality testing, and commercial production.

It ensures high quality and reliability, and aligns with global standards.

These parameters show the key quality measures and controls for evaluating Mirabegron API in production.

Chemical Name (IUPAC): (R)-2-(2-Aminothiazol-4-yl)-N-[4-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]phenyl]acetamide
CAS Number: 223673-61-8
Molecular Formula: C₂₁H₂₄N₄O₂S
Molecular Weight: 396.51 g/mol
Appearance: White to off-white crystalline powder
Identification Tests: IR spectroscopy, HPLC retention time comparison
Assay Method: HPLC (validated method)
Assay Limits: Typically 98.0%–102.0% on a dried basis
Related Substances / Impurities: Controlled as per pharmacopeial or in-house limits.
Residual Solvents: Within ICH Q3C limits
Elemental Impurities: Complies with ICH Q3D guidelines.
Loss on Drying / Water Content: Controlled to specified limits.
Microbial Limits: Meets pharmacopeial standards (or N/A for non-sterile APIs).
Polymorphic Form: This is required for consistent quality and performance.

Mirabegron API is stored in clean, airtight HDPE or fiber drums.

These drums are equipped with inner liners for additional protection.

Drums are sealed to keep out moisture and dust. The API should be stored in a cool, dry place.

Actiza Pharmaceutical Pvt. Ltd. is a reliable global supplier of Mirabegron API.

We provide high-quality manufacturing and reliable global supply chains.

Mirabegron API is manufactured to meet strict standards, such as those set by WHO-GMP and ISO.

We test each batch of the API to ensure it meets global quality standards for purity and stability.

We supply Mirabegron API to the Asia Pacific, Latin America, Middle East, Africa, and CIS regions.

Our strong logistics ensure timely deliveries in global markets.

Actiza Pharma delivers full support for its clients.

We handle everything from manufacturing and documentation to packaging, storage, and export services.

Our team is focused on making sure you get clear communication, flexible ordering, and fast support across different time zones.

This approach helps teams work together easily. It also builds strong, lasting business connections.