Product Overview
Irinotecan HCl Trihydrate API is a high-purity active ingredient.
It is a partly synthetic, water-soluble form of camptothecin.
It comes as a stable hydrochloride trihydrate and is produced under GMP conditions.
Therapeutic Applications
Irinotecan HCl Trihydrate API helps in developing and making anticancer medicines for treating solid tumors.
It helps to create formulations that are used to manage cancers like the colon, pancreas, lungs, ovaries, and cervix.
This API is generally used as a combination therapy and in research programs aimed at metastatic and advanced cancer stages.
Specification Parameters
These specs outline the requirements for quality, purity, and safety of the active ingredient Irinotecan HCl Trihydrate.
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Chemical name (IUPAC): Irinotecan Hydrochloride Trihydrate
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CAS Number: 136572-09-3
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Molecular formula: C₃₃H₃₈N₄O₆·HCl·3H₂O
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Molecular weight: ~677.18 g/mol
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Appearance: Pale yellow to off-white crystalline powder
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Identification tests: IR spectroscopy, HPLC retention time, chloride test
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Assay method: HPLC
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Assay specification: Typically ≥ 98.0% on a dried basis
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Related substances/impurities: Controlled by HPLC as per ICH limits
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Residual solvents: Tested by GC, within ICH Q3C limits
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Elemental impurities: Complies with ICH Q3D requirements
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Loss on drying/water content: About 7.0–10.0% w/w
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pH (solution): Around 5.0–6.5
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Microbial limits: TAMC ≤ 10³ cfu/g, TYMC ≤ 10² cfu/g; specified pathogens absent
Packaging & Storage
Irinotecan HCl Trihydrate API is packed using double LDPE liners placed inside HDPE drums or fiber drums.
These containers protect the API from light, moisture, and air.
The material stays safe in sealed, light-blocking packs and is kept in cool, dry conditions.
Kept at a steady 2–8 °C, this environment protects its stability and quality.
Why Choose Us
Actiza Industry is a reliable Indian pharmaceutical firm.
We provide high-quality Irinotecan HCl Trihydrate API.
Our quality systems are robust, ensuring a dependable supply.
GMP Quality
Our Irinotecan HCl Trihydrate API is manufactured following very strict GMP regulations.
It conforms to BP and USP standards, implying that it is very pure, safe, and of consistent quality.
This automatically makes it appropriate for the production of pharmaceuticals that are regulated in any part of the world.
Strong Expertise
We have skilled technical teams and a dedicated API subsidiary.
This helps us control sourcing, provide detailed documentation, and maintain strong product knowledge.
As a result, we support smooth development, scaling, and long-term supply needs.
Reliable Supply
We offer flexible order sizes and secure bulk packaging.
Our supply chain is very well organized; therefore, we are able to guarantee on-time delivery, identical batches, and continuous availability both for local and foreign customers.
Customer Focus
Actiza Industry offers global support that is quick and reliable.
They ensure clear communication and affordable solutions.
This helps partners meet quality goals without losing trust or strong, long-term relationships.
