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Irinotecan HCI Trihydrate API

Name of Product Irinotecan Hci Trihydrate
CAS No 136572-09-3
Therapeutic use:- Anti Cancer
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Irinotecan HCl Trihydrate API is a key active pharmaceutical ingredient.

It is supplied for making injectable formulations. It is a camptothecin derivative that dissolves in water and is made under strict quality standards.

This API is recognized for its clear chemical structure and solid stability profile.

It is ideal for making regulated medicines in worldwide supply chains.

Therapeutic Applications

Irinotecan HCl Trihydrate API is used to manufacture drugs that are applied in the treatment of cancer.

It aids in the formulation of a composition that addresses different kinds of cancers.

This API is often combined with other treatments. It is also used in research studies on advanced cancer stages.

Specification Parameters

This includes the requirements for Irinotecan HCl Trihydrate based on quality and purity standards, along with its safety factors.

  • Chemical name (IUPAC): Irinotecan Hydrochloride Trihydrate

  • CAS Number: 136572-09-3

  • Molecular formula: C₃₃H₃₈Nâ‚„O₆·HCl·3Hâ‚‚O

  • Molecular weight: ~677.18 g/mol

  • Appearance: Pale yellow to off-white crystalline powder

  • Identification tests: IR spectroscopy, HPLC retention time, and chloride test.

  • Assay method: HPLC

  • Assay specification: Typically ≥ 98.0% on a dried basis

  • Related substances/impurities: Controlled by HPLC as per ICH limits.

  • Residual solvents: Tested by GC, within ICH Q3C limits.

  • Elemental impurities: Complies with ICH Q3D requirements

  • Loss on drying/water content: About 7.0–10.0% w/w

  • pH (solution): Around 5.0–6.5

  • Microbial limits: TAMC ≤ 10³ cfu/g, TYMC ≤ 10² cfu/g; specified pathogens are absent

    Packaging & Storage

    Irinotecan HCl Trihydrate API is usually supplied in HDPE or fibre drums.

    It does not allow the entry of light, moisture, or air.

    This API is stored in a cold and dry place in specially devised light-blocking packaging.

    This helps preserve its quality and keeps it stable.

    Why Choose Us

    Actiza Pharmaceutical Pvt. Ltd. is a reliable Indian pharmaceutical firm. As a trusted API manufacturer, We offer top-quality Irinotecan HCl Trihydrate API and ensure a steady supply.

    GMP Quality

    We make our Irinotecan HCl Trihydrate API under strict GMP rules.

    It meets BP and USP standards, meaning it is pure, safe, and consistent in quality.

    This makes it good for producing pharmaceuticals that are regulated worldwide.

    Strong Expertise

    We have skilled technical teams and a dedicated API subsidiary.

    This helps us control sourcing and provide detailed documentation.

    We have strong product knowledge, supporting smooth development and supply.

    Reliable Supply

    We offer flexible order sizes and secure bulk packaging. Our supply chain is well organized.

    We can assure on-time delivery, uniform batches, and continuous availability for local and overseas customers.

    Customer Focus

    Actiza Pharmaceutical Pvt. Ltd. offers global support that is quick and reliable.

    They ensure clear communication and affordable solutions.

    This allows partners to reach quality goals and maintain trust and lasting relationships. Â