Product Overview
Erlotinib API is a high-purity active pharmaceutical ingredient used in oncology formulations.
It is a quinazoline-based compound that blocks EGFR signals linked to abnormal cell growth.
It is provided as a fine crystalline powder. Made under GMP conditions, it is built for stable and reliable oral dosage development.
Therapeutic Applications
Erlotinib API is applied as a core active pharmaceutical ingredient in targeted oncology formulations.
It is used in the treatment of EGFR-positive non-small cell lung cancer and advanced pancreatic cancer.
The API also helps create combination products, personalized cancer treatments, and generic anticancer medicines.
Specification Parameters
Erlotinib API specs set the bar for quality, purity, and safety.
These benchmarks provide stable performance in drug production, all while adhering to strict rules.
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Molecular Formula: C₂₂H₂₃N₃O₄
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Chemical Name (IUPAC): N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine
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CAS no.: 183321-74-6
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Molecular Weight: 393.44 g/mol
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Appearance: A white to off-white crystalline powder that is free of visible foreign particles.
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Identification: Confirmed by IR and HPLC methods for structural accuracy.
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Assay (Purity): Typically not less than 98.0% on a dry basis.
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Assay Method: Determined by validated HPLC technique
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Related Substances / Impurities: Individual and total impurities controlled within specified limits.
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Total Impurities: Maintained within strict acceptable limits.
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Loss on Drying: Controlled to ensure low moisture content.
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Residual Solvents: Comply with ICH solvent guidelines.
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Particle size: Kept consistent for even blending and processing.
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Elemental Impurities: Controlled according to ICH Q3D requirements
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Identification Tests: Confirmed by IR and HPLC methods
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Polymorphic Form: A clear crystal form keeps batches consistent.
Packaging & Storage
Erlotinib API is packed in strong HDPE or fibre drums for safety.
These tightly sealed drums keep out moisture and block light exposure.
Store the API in a room with a consistent temperature, away from direct sunlight, and keep it clean and dry.
This helps it last longer and stay in good condition.
Why Choose Us
Actiza Industry provides top-quality Erlotinib API.
We have stable production and a global presence, backed by strong regulations.
This lets us meet diverse oncology supply needs in different regions.
Proven Quality
Erlotinib API is made under WHO-GMP and ISO standards.
This ensures high purity and consistency in each batch.
Strict quality checks help support safe and reliable pharmaceutical development.
Global Reach
We export to 40+ countries and support over 500 global clients.
This means smooth supply, on-time delivery, and solid documentation for regulated and semi-regulated markets.
Strong Experience
We have over 12 years of experience and a massive portfolio of 2,000+ items.
This helps us source Erlotinib API quickly and efficiently for our customers.
You can trust our technical expertise for a reliable partnership.
End-to-End Support
Actiza Industry offers ready-made dossiers, flexible order sizes, and fast support across time zones.
Our integrated API manufacturing helps clients go from sourcing to launch faster.
