Product Overview
Pirfenidone API is a synthetic ingredient used in medicines.
It is made using a controlled chemical synthesis process.
It has a well-defined molecular structure, is highly pure, and has consistent properties.
The API is made under strict cGMP conditions. It carefully controls impurities, solvents, and quality aspects.
This helps ensure reliable pharmaceutical development.
Therapeutic Applications
Pirfenidone API clear molecular profile helps create precise formulas.
It also ensures consistent processing and delivers reliable performance. The API gives steady results.
This makes it a trusted option for creating advanced pharmaceuticals.
Specification Parameters
Pirfenidone API specifications define the standards for identity, purity, and quality.
These must be met for pharmaceuticals to be manufactured properly and in compliance with regulations.
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Chemical Name (IUPAC): 5-Methyl-1-phenyl-2-(1H)-pyridone
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CAS Number: 53179-13-8
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Molecular Formula: C₁₂H₁₁NO
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Molecular Weight: 185.22 g/mol
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Appearance: White to pale yellow crystalline powder
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Identification Tests: IR and HPLC retention time comparison
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Assay Method: HPLC
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Assay Range: Typically 98.5%–101.0% (on dried basis)
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Related Substances / Impurities: Controlled by HPLC with defined limits
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Residual Solvents: As per ICH Q3C guidelines
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Elemental Impurities: Complies with ICH Q3D limits
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Loss on Drying / Water Content: NMT 1.0%
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Microbial Limits: N/A for non-sterile API; objectionable organisms controlled
Packaging & Storage
Pirfenidone API is carefully packed to ensure stability.
It is packed in strong 25 kg HDPE or fiber drums to provide mechanical protection and prevent moisture damage.
Store the API in a cool, dry place, protected from light and moisture.
Why Choose Us
Actiza Industry, based in India, is a reliable API manufacturer.
We offer high-quality Pirfenidone API that meets global standards.
High Quality
The quality of the raw materials and the final API is consistently checked to ensure that high-quality standards are maintained throughout the process.
We are WHO-GMP certified, which means we can supply safe, consistent Pirfenidone API worldwide.
Advanced Facilities
Our factories rely on advanced machines and automated systems.
We have dedicated zones for each process. This setup keeps production efficient and stops contamination.
Reliable Supply
We deliver Pirfenidone API on time and with reliable quality.
We have all the necessary resources in-house, which makes our supply chains very reliable.
Expert Team
Our skilled research and production team works closely with advanced machines.
This offers affordable, high-quality APIs that meet global standards.
