PHR1810

Tadalafil

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinónimos: Tadalafil
• Fórmula empírica (notación de Hill): C₂₂H₁₉N₃O₄
• Número de CAS: 171596-29-5
• Peso molecular: 389.40
• Código UNSPSC: 41116107
• NACRES: NA.24

Propiedades

• grado: certified reference material; pharmaceutical secondary standard
• Nivel de calidad: 300
• Agency: traceable to Ph. Eur. Y0001417; traceable to USP 1642879
• familia API: tadalafil
• formulario: powder
• CofA: current certificate can be downloaded
• envase: pkg of 500 mg
• técnicas: HPLC: suitable; gas chromatography (GC): suitable
• aplicaciones: pharmaceutical (small molecule)
• temp. de almacenamiento: 2-30°C
• InChI: 1S/C22H19N3O4/c1-24-10-19(26)25-16(22(24)27)9-14-13-4-2-3-5-15(13)23-20(14)21(25)12-6-7-17-18(8-12)29-11-28-17/h2-8,16,21,23H,9-11H2,1H3/t16-,21-/m1/s1
• Clave InChI: WOXKDUGGOYFFRN-IIBYNOLFSA-N

Descripción

Descripción general

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.

Tadalafil is a phosphodiesterase type 5 inhibitor that prevents the hydrolysis of cyclic adenosine monophosphate and cyclic guanosine monophosphate.

Aplicación

This pharmaceutical secondary standard can also be used as follows:

• Square-wave voltammetric (SWV) determination of tadalafil in pharmaceutical samples using a boron-doped diamond electrode (BDDE)
• Development of multi-walled and vertically oriented carbon nanotubes (voMWCNT) based electrochemical sensor for the detection of tadalafil in pharmaceutical samples
• Simultaneous determination of sildenafil, tadalafil, and vardenafil in pharmaceutical preparations by a high-temperature gas chromatography/mass spectrometry (HTGC/MS) method
• Development and validation of spectrophotometric methods for the combined analysis of dapoxetine hydrochloride and tadalafil in bulk and pharmaceutical dosage forms
• Spectrophotometric quantification of tamsulosin hydrochloride and tadalafil in their combined pharmaceutical preparation, following International Conference on Harmonization (ICH) guidelines

Nota de análisis

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

Nota al pie de página

To see an example of a Certificate of Analysis for this material enter LRAB8867 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Información de seguridad

• Pictogramas: GHS07
• Palabra de señalización: Warning
• Frases de peligro: H315,H319,H335
• Consejos de prudencia: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Clasificaciones de peligro: Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Órganos de actuación: Respiratory system
• Código de clase de almacenamiento: 11 - Combustible Solids
• Clase de riesgo para el agua (WGK): WGK 3
• Punto de inflamabilidad (°F): Not applicable
• Punto de inflamabilidad (°C): Not applicable