Product Overview
Sorafenib API is an active pharmaceutical ingredient made under strict quality systems.
It has high purity and controlled impurity levels.
The API is produced with a stable form and consistent quality.
It meets the standards of pharmacopeias and follows global rules.
Sorafenib API is a trusted choice for formulating products and serving the regulated market.
Therapeutic Applications
Sorafenib API is used in the production of cancer-focused medications.
It is mainly suitable for oral solid dosage development. This API is for regulated formulation programs.
It ensures precise potency and stability. The API meets complex formulation needs.
It ensures that purity, consistency, and compliance with global standards are well controlled.
Specification Parameters
These specification parameters outline the identity, purity, and quality of Sorafenib API.
This ensures its consistent use in making pharmaceuticals.
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Chemical Name (IUPAC): 4-[4-[[[4-Chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide
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CAS Number: 284461-73-0
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Molecular Formula: C₂₁H₁₆ClF₃N₄O₃
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Molecular Weight: ~464.82 g/mol
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Appearance: White to off-white crystalline powder
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Identification Tests: IR spectroscopy and HPLC comparison
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Assay Method: HPLC
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Assay: NLT 99.0% (on a dried basis)
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Related Substances / Impurities: Single impurity NMT 0.10%; total impurities NMT 0.50%
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Residual Solvents: As per ICH Q3C limits.
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Elemental Impurities: Complies with ICH Q3D guidelines.
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Loss on Drying / Water Content: NMT 1.0%
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Residue on Ignition: NMT 0.5%
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Microbial Limits: Not applicable (N/A)
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Solubility: Practically insoluble in water; soluble in selected organic solvents.
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Particle Size Distribution: Controlled for formulation suitability
Packaging & Storage
Sorafenib API in bulk is packed inside fiber drums or HDPE drums.
The containers are tightly closed to prevent the entry of moisture and contaminants.
The API is stored in a cool and dry place. The sorafenib API has to be protected from light and maintained away from heat sources, and other reactant substances.
Why Choose Us
Actiza Industry offers high-quality Sorafenib API.
We focus on strong manufacturing support and maintain strict quality systems for great results.
Global Standards
Our Sorafenib API is made under WHO-GMP standards.
Our quality systems are strict, and our processes are fully checked.
We keep detailed records to meet international pharmacopeial and regulatory rules.
Advanced Facilities
We operate modern plants with automated machines.
They control HVAC systems with different zones for various processes.
These lower contamination risks ensure that every batch of API is of high quality.
Strong Integration
We give in-house help for API production and formulation.
This helps us better control raw materials and timelines.
This backward approach ensures a steady supply flow. It raises quality and speeds up manufacturing.
Reliable Supply
We offer flexible order sizes, secure bulk packaging, and fast global delivery.
Our team aims to ensure you understand us easily.
We follow all the necessary regulations and offer dependable service.
