Irinotecan hydrochloride trihydrate CAS 136572-09-3

Key Features

✔ Topoisomerase I Inhibitor: Widely used chemotherapy drug
✔ High Purity: ≥99.0% (HPLC) pharmaceutical-grade
✔ Stabilized Form: Trihydrate provides improved stability vs. anhydrous form
✔ Ready-to-Formulate: Suitable for IV solutions & liposomal preparations
✔ Regulatory Compliance: Meets USP/EP/JP pharmacopeial standards

Batch-specific CoA available on request.

Product Description

This semi-synthetic camptothecin derivative features:

Active Lactone Form: Maintains critical E-ring configuration (<20% carboxylate form)
Bis-piperidine Side Chain: Enhances water solubility while maintaining antitumor activity
pH-Dependent Equilibrium: Lactone↔Carboxylate ratio optimized for clinical efficacy

Clinical Advantages:
● Broad-spectrum activity against colorectal, lung & pancreatic cancers
● Conversion to active metabolite SN-38 by carboxylesterases
● Synergistic with 5-FU/leucovorin in FOLFIRI regimens

1. Product Identification

Chemical Name: (S)-4,11-Diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl-[1,4'-bipiperidine]-1'-carboxylate hydrochloride trihydrate
CAS: 136572-09-3
Molecular Formula: C₃₃H₃₈N₄O₆·HCl·3H₂O
Molecular Weight: 677.19 g/mol
Structural Verification:
- HPLC Rt: 8.2 min (USP method)
- [α]²⁵D +67° (c=1, MeOH)
- Characteristic UV λmax: 220, 254, 370 nm

2. Quality Specifications

Parameter	Specification	Test Method
Appearance	Pale yellow crystalline powder	Visual
Purity (HPLC)	≥99.0%	USP <621>
Lactone Form	≥80%	pH 3 buffer HPLC
Water Content	7.5-9.5% w/w	Karl Fischer
SN-38 Impurity	≤0.15%	Gradient HPLC
Heavy Metals	≤10 ppm	ICP-MS

3. Physicochemical Properties

Melting Point: 256-258°C (dec.)
Solubility:
- Freely soluble: Water (>50 mg/mL at pH 3)
- Soluble: Methanol, DMSO
- Insoluble: Chloroform, hexane
pKa Values:
- Tertiary amine (protonated): 6.8
- Phenolic OH: 9.4
LogD (pH 7.4): 2.3 ± 0.2
Stability:
- Solution: Stable 24h at pH 3-4 (4°C)
- Solid: 3-year shelf life at 2-8°C (<30% RH)

4. Product Applications

Pharmaceutical Uses

Ready-to-Dilute Formulations:
- Lactated Ringer's compatible IV solutions
- PEGylated liposome encapsulation
Combination Therapies:
- With monoclonal antibodies (cetuximab/bevacizumab)

Research Applications

Drug Resistance Studies:
- ABCG2 transporter inhibition assays
Nanocarrier Development:
- Hyaluronic acid-drug conjugates

5. Packaging & Storage

Primary Packaging:
- Clinical Use: Sterile vials (10-500mg) with nitrogen overlay
- Bulk: Double HDPE bags with desiccant
Storage Conditions:
- Temperature: 2-8°C (short excursions ≤25°C allowed)
- Humidity: ≤30% RH
- Light: Protect from UV/visible light
Shelf Life: 36 months when stored properly

6. Safety & Handling

GHS Classification

H301: Toxic if swallowed
H315: Skin irritation
H334: May cause allergic reactions
H351: Suspected carcinogen

Safe Handling Protocol

PPE: Double gloves (nitrile), face shield, Tyvek® suits
Containment: Isolator technology recommended
Deactivation: 0.1M NaOH solution (destroys lactone ring)

First Aid Measures

Inhalation: Move to fresh air immediately
Ocular: Flush with sterile irrigation solution
Dermal: Wash with 5% ascorbic acid solution

Product MOQ

We understand that your requirements vary across different stages, from R&D and pilot scale to commercial production. Therefore, we support both:

R&D Samples: We offer sample sizes from gram to kilogram scale to support your early-stage project evaluation.
Commercial Supply: We provide standard industrial packaging (e.g., 25kg drums, 200kg drums) and have a stable capacity for bulk supply.

For detailed information on the Minimum Order Quantity (MOQ) for a specific product or to discuss custom packaging solutions, please contact our sales team.

Our Customization Capabilities Include

We bridge the gap between your concept and a commercial-ready product. Our flexible manufacturing and expert R&D team empower us to deliver fully customized chemical solutions.

Custom Synthesis: We develop molecules from lab scale to industrial production.
Specification Adjustment: We modify purity, form, and other key parameters to fit your application.
Flexible Packaging: We provide custom packaging and labeling to streamline your supply chain.

Tell us your challenge. We’ll build the solution.

Large or Small Order

Sample and bulk orders are welcome.
Supplying from grams to tons. Inquire for pricing.
We treat every order with the same dedication, large or small.

Technical Downloads

Technical Data Sheet (TDS)
Safety Data Sheet (SDS)
Request Certificate of Analysis (CoA)
Request a Quote

Inquiry & Ordering Information

Submit Inquiry: Contact us with the Product/CAS No., Quantity, and Purity requirements.
Receive Quote: Our team will provide a formal quotation and lead time.
Place Order: Confirm by issuing an official Purchase Order (PO).

Questions? Contact Us anytime.

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Reischbio provides confidential custom synthesis services, structured for innovative companies requiring unique and proprietary molecules. Our expert chemists leverage state-of-the-art reaction technologies to tackle complex, multi-step synthesis projects, from milligrams to multi-kilogram scale. Governed by strict IP protection protocols, we function as a seamless extension of your R&D team. Our agile project management and transparent communication ensure projects are delivered on-time and on-spec. With our bespoke chemistry solutions, we empower you to overcome scientific challenges, secure critical IP, and accelerate your path to innovation.