Irinotecan Hydrochloride Trihydrate Pharmaceutical Raw Drug

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Irinotecan Hydrochloride Trihydrate Specification

Product Name: Irinotecan Hydrochloride Trihydrate
CAS: 136572-09-3
Level: Pharmaceutical grade
Content: 99%
Appearance: white powder
Number of meshes:80 mesh
Packing: 500G/aluminum foil bag
Category: Plant Extracts
Field: Pharmaceuticals
Deferred products: irinotecan hydrochloride tablets; irinotecan hydrochloride injection
Use: For patients with advanced colorectal cancer, combined with 5-fluorouracil and folinic acid in patients with advanced colorectal cancer who have not received chemotherapy before, as a single medication, to treat patients who failed treatment with 5-fluorouracil chemotherapy
Usage and dosage: 1 A method for small cell lung cancer and non-small cell lung cancer, B method for cervical cancer and ovarian cancer. A method: adult 100mg/m2, intravenous drip, 1 week interval and then repeat the intravenous infusion, 3 to 4 times for a course of treatment. At least two weeks before the next course of treatment. Need to repeat a few courses. B method: 150 mg/m2, 1 intravenous drip, withdrawal for 2 weeks. Repeat 2 or 3 times in this way as a course of treatment, at least 3 weeks before stopping treatment for the next course of treatment. This method can be repeated. The dose may be appropriately increased or decreased according to age, weight, and condition. 2 When this product is used, it needs to be mixed with more than 500ml of physiological saline, glucose solution or electrolyte infusion agent, and then slowly instill for more than 90 minutes.

 

Irinotecan Hydrochloride Trihydrate Certificate of Analysis

Product name Irinotecan Hydrochloride Trihydrate
CAS No. 100286-90-6 Outer Packing 25kg/drum
Production date Sep, 28, 2017 Shelf life Sep, 27, 2019
Standard adopted Enterprise Standard
Items of analysis Specification Results
ASSAY (on dried basis) 98.0%–102.0% 99.8%
CHARACTERS Light yellow or almost yellow,crystalline powder and odorless. Conforms
IDENTIFICATION Infrared Absorption:In accordance with the reference Standard spectrum of Irinotecan Hydrochloride. Conforms
RESIDUE ON IGNITION NMT 0.1 % 0.07 %
HEAVY METALS NMT 0.001 % <0.001%
WATER(K.F) 7.0 %—9.0 % 8.3 %
RELATED COMPOUNDS (HPLC) (on dried basis) 11-Ethyl irinotecanc≤0.15%

7,11-Diethyl-10-hydroxycamptothecing≤0.15%

Undetected

Undetected

Conclusion Qualified

 

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