Avatrombopag Maleate 677007-74-8

Assay ≥99.0% with Single Impurity ≤0.10% by HPLC, GMP, DMF/DML

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Product Details

Product Information

Product name	Avatrombopag Maleate
CAS No.	677007-74-8
Molecular Formula	C₂₉H₃₄Cl₂N₆O₃S₂.C₄H₄O₄
Molecular Weight	765.72
Quality Standard	99% up by HPLC, GMP, DMF/DML
Appearance	White or off-white powder

COA

Test Items	Specifications	Results
Appearance	White or off-white powder	Off-white powder
Solubility	This product is slightly soluble in ethanol and practically insoluble or insoluble in water or acetone.	Slightly soluble in ethanol; practically insoluble or insoluble in water or acetone.
HPLC Identification	The retention time of the principal peak in the chromatogram of the test solution obtained in the related substances corresponds with that of the avatrombopag peak in system suitability solution.	Conforms
Appearance of solution	The infrared light absorption spectrum of this product should be concordant with Reference substance	Conforms
Related substances	AFQB105-Z5≤0. 15%	0.033%
	AFQB-Z2≤0. 15%	0.029%
	AFQB-Z3≤0. 15%	0.017%
	Total impurities ≤0. 5%	0.21%
	Any single impurity ≤0. 10%	0.03%
Maleic acid	14.4%~ 15.9%	14.7%
N-Nitroso	50 ppm	ND
Particle size	D(90)<10 μm	3.44 μm
N-Methylpyrrolidone	N-Methylpyrrolidone≤0.05%	ND
Water	≤0.5%	0.22%
Residue on ignition	≤0. 1%	0.03%
Residual solvents	Acetone≤0.5%	ND
	Dichloromethane≤0.06%	ND
	Tetrahydrofuran≤0.072%	0.0027%
	Pyridine≤0.02%	ND
Heavy metals	Not more than 20ppm	< 20ppm
Heavy metals	Total number of aerobic bacteria ≤ 10³cfu/g	<50cfu/g
Microbial limit	Total number of molds and yeast ≤ 10²cfu/g	<20cfu/g
Microbial limit	Escherichia coli should not be detected/g	ND
Assay (by HPLC)	Calculated as anhydrous, the content of C₂₉H₃₄Cl₂N₆O₃S₂.C₄H₄O₄should be 98.0%~ 102.0%	99.7%
Conclusion	It conforms to all the house specification

Usage

Basic Information

Avatrombopag Maleate is the active pharmaceutical ingredient of the oral thrombopoietin receptor agonist Avatrombopag. The maleate salt is used to enhance the drug's stability and bioavailability.

Primary Uses/Indications

This medication is specifically indicated for the treatment of thrombocytopenia (low platelet count) in the following conditions:

1. Thrombocytopenia in Adult Patients with Chronic Liver Disease (CLD)

Use: To increase platelet counts in adults with CLD who are scheduled to undergo a medical or dental procedure (e.g., liver biopsy, dental extraction), thereby reducing the risk of bleeding during the procedure.

2. Thrombocytopenia in Adult Patients with Chronic Immune Thrombocytopenia (ITP)

Use: To increase and maintain platelet counts in adults with chronic ITP who have had an insufficient response to prior therapy (e.g., corticosteroids, immunoglobulins).

Mechanism of Action

Avatrombopag is a thrombopoietin receptor agonist (TPO-RA). It mimics the action of the body's natural thrombopoietin (TPO) by binding to and activating the TPO receptor on megakaryocytes in the bone marrow, thereby stimulating platelet production.

Key Facts

1. Dosage Form: Oral tablet, convenient for administration.

2. Dosing Schedule: When used prior to a procedure, treatment is typically initiated 10-13 days before the scheduled intervention.

3. Core Component: "Avatrombopag" is the active moiety, and "maleate" is the salt form it is prepared as for stability; both refer to the same drug with identical pharmacological effects in the body.

Important Note: Must be used under the supervision of a physician with regular monitoring of platelet counts.