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Lapatinib API

Name of Product Lapatinib API
CAS No 231277‑92‑2
Therapeutic use:- Small‑molecule tyrosine kinase inhibitor targeting EGFR/HER2; used for HER2+ breast cancer
Grade IP/USP/EP/BP
Form:- API Powder
Status Regular

Product Overview

Lapatinib is a well-known oncology active pharmaceutical ingredient (API).

It is a member of a class of drugs called tyrosine kinase inhibitors.

These API work by blocking growth signals in cancer cells.

Lapatinib is used mainly in HER2 receptor-positive breast cancer.

HER2-positive cancer cells grow and multiply rapidly.

Lapatinib slows down this process by blocking two significant pathways: HER2 and EGFR.

Because of this dual action, it works where other treatments do not.

Lapatinib gives doctors another option to treat advanced breast cancer.

Lapatinib is only produced in controlled pharmaceutical factories under stringent international guidelines.

Therapeutic Applications

  • Breast cancer: Given with capecitabine or letrozole for advanced cases.

  • Resistant cases: Helps when patients no longer respond to trastuzumab.

  • Targeted therapy: Focuses on cancer cells, so normal cells are less harmed.

    By targeting the cause of cancer cell growth, Lapatinib offers patients the potential to manage disease progression with fewer side effects compared to general chemotherapy.

    Specification Parameters

    • CAS Number: 231277-92-2 (free base) / 388082-78-8 (salt)

    • Molecular Formula: C29H26ClFN4O4S

    • Molecular Weight: 581.05 g/mol (free base)

    • Appearance: Yellow to orange crystalline powder

    • Purity (HPLC): ≥ 99%

    • Solubility: Poor in water, but soluble in ethanol, methanol, and DMSO

    • Melting Point: Approximately 137–139°C

    • Identification Tests: Confirmed by IR spectra and HPLC retention time

    • Residual Solvents: Below ICH Q3C accepted levels

    • Heavy Metals: Within pharmacopeial limits (<10 ppm)

    • Microbial Limits: Meets pharmacopeial standards

      Packaging & Storage

      Each pack is nicely labeled with API name, batch no., Date of manufacture, expiry date, and handling instructions.

      Lapatinib API is well packed to maintain quality and stability.

      • Packaging: Supplied in sealed HDPE bottles, aluminum foil bags, or fiber drums. Inner polyethylene liners provide extra protection.

      • Pack sizes: From small 1 g and 10 g packs for research to 1 kg and 25 kg bulk packs for production.

      • Storage conditions: Keep in a cool, dry place at 2–8°C. Protect from light, heat, and moisture.

      • Shelf life: 2–3 years if stored in recommended conditions.

        Why Choose Us

        • High quality: Made under GMP rules with strict checks by Actiza.

        • Regulatory support: DMF and CTD files ready for global use.

        • Flexible supply: From small test packs to full bulk supply.

        • Global reach: Exported to the US, the EU, Asia, and Latin America.

        • Expert support: Teams help with technical and regulatory needs.