PHR1784

Aripiprazole

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Aripiprazole, 7-{4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydro-2(1H)-quinolinone
• Empirical Formula (Hill Notation): C₂₃H₂₇Cl₂N₃O₂
• CAS Number: 129722-12-9
• Molecular Weight: 448.39
• UNSPSC Code: 41116107

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0001649; traceable to USP 1042634
• API family: aripiprazole
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• InChI: 1S/C23H27Cl2N3O2/c24-19-4-3-5-21(23(19)25)28-13-11-27(12-14-28)10-1-2-15-30-18-8-6-17-7-9-22(29)26-20(17)16-18/h3-6,8,16H,1-2,7,9-15H2,(H,26,29)
• InChI key: CEUORZQYGODEFX-UHFFFAOYSA-N

Description

General description

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Aripiprazole is a benzisoxazole derivative and second-generation antipsychotic and anti-depressant drug. It is used in the management of schizophrenia and bipolar I disorder. It shows partial agonistic activity towards dopamine D2 and serotonin 5-HT_1A receptors and antagonistic activity at 5-HT_2A receptors.

Application

This pharmaceutical secondary standard can also be used as follows:

• Development of a reversed phase-high-performance liquid chromatography (RP-HPLC) method for the determination of aripiprazole in the presence of nine of its impurities in both bulk and its pharmaceutical formulations
• Direct voltammetric determination of aripiprazole in pharmaceutical formulations, human serum, and urine samples
• Simultaneous estimation of aripiprazole and octoclothepin in pharmaceutical formulations and human urine samples by two different voltammetric methods using glassy carbon electrodes
• UV-spectroscopic determination of aripiprazole in pure and tablet formulations following ICH guidelines
• Multi-analysis of aripiprazole, clozapine, and sulpiride in pharmaceutical formulations and biological fluids by extraction-free UV-Visible spectrophotometric methods based on the ability of the three antipsychotic drugs to form stable ion-pair complexes with bromophenol blue (BPB) and bromothymol blue (BTB)

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0259 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H302
• Precautionary Statements: P264 - P270 - P301 + P312 - P501
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable