PHR1810

Tadalafil

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Tadalafil
• Formule empirique (notation de Hill): C₂₂H₁₉N₃O₄
• Numéro CAS: 171596-29-5
• Poids moléculaire : 389.40
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0001417; traceable to USP 1642879
• Famille d'API: tadalafil
• Forme: powder
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 500 mg
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Température de stockage: 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
• Clé InChI: WOXKDUGGOYFFRN-IIBYNOLFSA-N

Description

Description générale

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.

Application

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

Remarque sur l'analyse

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

Note de bas de page

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.

Informations sur la sécurité

• Pictogrammes: GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H315,H319,H335
• Conseils de prudence: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Classification des risques: Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Organes cibles: Respiratory system
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable