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Gemcitabine Hydrochloride API

Name of Product Gemcitabine Hydrochloride API
CAS No 122111‑03‑9
Therapeutic use:- Antineoplastic nucleoside analog (pyrimidine antimetabolite) used against breast, lung, pancreatic cancers
Grade IP/USP/EP/BP
Form:- API Powder
Status Commercial

Product Overview

Gemcitabine Hydrochloride is a man-made drug that is utilized as an API.

It falls under the category of drugs called nucleoside analogs.

The drug works by inhibiting DNA from duplicating itself.

When It inhibits DNA synthesis, preventing cancer cell proliferation, the cancer cells are not able to grow.

This makes the drug effective against multiple solid tumors.

Supplied as bulk API for formulation manufacturing. It comes in a white or off-white powder form.

It is soluble in water. Complies with USP and EP pharmacopeia standards.

This ensures quality based on international regulations.

Therapeutic Applications

Gemcitabine Hydrochloride (122111-03-9) has its main usage in oncology.

It is highly valued due to its broad spectrum of activity and use as a single-agent, as well as combined, cancer therapy.

Its therapeutic uses are:

  • Non-small cell lung cancer (NSCLC): as a first-line agent or in combination therapies.

  • Pancreatic cancer: one of the standard first-line chemotherapies.

  • Breast cancer: often used in combination with paclitaxel.

  • Bladder cancer: applied as part of combination chemotherapy regimens.

  • Ovarian cancer: used with platinum compounds like carboplatin.

    Specification Parameters

    These parameters ensure the product is suitable for use in regulated pharmaceutical markets. Typical quality specifications for Gemcitabine Hydrochloride API include:

    • CAS Number: 122111-03-9

    • Molecular Weight: 299.66 g/mol (base)

    • Appearance: White or off-white crystalline powder

    • Solubility: Freely soluble in water

    • Purity: Not less than 99.0% by HPLC

    • Moisture Content: NMT 1.0%

    • Chemical structure: C9H11F2N3O4·HCL

    • Pharmacopeia Compliance: USP / EP

      Packaging & Storage

      For stability, the product should be stored at 2–8°C, protected from heat and moisture.

      It should always remain sealed until use. Shelf life is typically 24 to 36 months under recommended storage conditions.

      Gemcitabine Hydrochloride is packaged in:

      • HDPE drums or fiber drums lined with double polyethylene bags.

      • Standard pack sizes: 1 kg, 5 kg, or 25 kg per drum.

        Why Choose Us

        At Actiza Pharmaceutical Pvt Ltd, we specialize in providing high-quality oncology APIs like Gemcitabine Hydrochloride (122111-03-9).

        Partnering with us ensures access to reliable oncology APIs backed by quality assurance and competitive pricing.

        Buyers choose us because:

        • Full support for DMF and CTD filings across global markets.

        • Manufacturing under GMP-certified facilities.

        • Scalable production ensures consistent availability.

        • Exports to regulated and semi-regulated markets worldwide.

        • Dedicated technical and regulatory support teams.