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Aripiprazole USP EP NF BP Ph Eur Grade Supplier Exporter Manufacturers' Representative |
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Aripiprazole
CAS Number: 129722-12-9
Molecular Formula: C23H27Cl2N3O2
Molecular Weight: 448.39
Aripiprazole
General Properties and Specifications of Aripiprazole:
Appearance: White to off-white, crystalline powder.
Assay: Between 98% and 102%
Identifications: By IR and by HPLC.
Loss on drying: 0.5% maximum.
Residue on ignition: 0.1% maximum.
Related inpurities:
Aripiprazole related compound G: 0.1% maximum.
Aripiprazole related compound F: 0.1% maximum.
Aripiprazole 4,4’ dimer: 0.1% maximum.
Any other individual impurity: 0.1% maximum.
Total impurities: 0.5% maximum.
Residual solvents:
Methanol: 1000 ppm maximum.
Isopropyl alcohol: 1000 ppm maximum.
Acetonitrile: 300 ppm maximum.
N-Hexane: 200 ppm maximum.
Tetrahydrofurane: 600 ppm maximum.
Triethylamine: 320 ppm maximum.
Relative Density: about 1.3
Melting Point: 137C to 140C literature.
Boiling Point: 646C.
Solubility: Freely soluble in dichloromethane. Sparingly soluble in toluene. Insoluble in methanol and water.
Storage: Preferably 2C to 8C. OK to freeze. Protected from light.
Aripiprazole USP Grade Specifications:
C23H27Cl2N3O2 448.39
2(1H)-Quinolinone, 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-;
7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril CAS 129722-12-9].
UNII: 82VFR53I78
DEFINITION
Aripiprazole contains NLT 98.0% and NMT 102.0% of aripiprazole (C23H27Cl2N3O2), calculated on the dried basis.
IDENTIFICATION
A. Infrared Absorption
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test.
Aripiprazole related compound G: 0.1% maximum.
Aripiprazole related compound F: 0.1% maximum.
Aripiprazole 4,4’ dimer: 0.1% maximum.
Any other individual impurity: 0.1% maximum.
Total impurities: 0.5% maximum.
Loss on Drying: Dry at 105C for 3 h. Aceptance criteria: NMT 0.5%
Packaging and Storage: Preserve in tight containers. Store at controlled room temperature.
Aripiprazole is also supplied in EP BP Ph Eur Grade.
Please visit SDS Safety Data Sheet of Aripiprazole Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org