PHR1957

Tenofovir disoproxil fumarate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Tenofovir disoproxil fumarate, Bis(POC)PMPA fumarate, Bis{[(Isopropoxycarbonyl)oxy]methyl} ({[(2R)-1-(6-amino-9H-purin-9-yl)-2-propanyl]oxy}methyl)phosphonate fumarate
• Formule empirique (notation de Hill): C₁₉H₃₀N₅O₁₀P · C₄H₄O₄
• Numéro CAS: 202138-50-9
• Poids moléculaire : 635.51
• Numéro MDL: MFCD08141829
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to USP 1643656
• Famille d'API: tenofovir
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 500 mg
• Application(s): pharmaceutical
• Format: neat
• Température de stockage: 2-8°C
• Chaîne SMILES: OC(/C=C/C(O)=O)=O.NC1=C2C(N(C[C@@H](C)OCP(OCOC(OC(C)C)=O)(OCOC(OC(C)C)=O)=O)C=N2)=NC=N1
• InChI: 1S/C19H30N5O10P.C4H4O4/c1-12(2)33-18(25)28-9-31-35(27,32-10-29-19(26)34-13(3)4)11-30-14(5)6-24-8-23-15-16(20)21-7-22-17(15)24;5-3(6)1-2-4(7)8/h7-8,12-14H,6,9-11H2,1-5H3,(H2,20,21,22);1-2H,(H,5,6)(H,7,8)/b;2-1+/t14-;/m1./s1
• Clé InChI: VCMJCVGFSROFHV-WZGZYPNHSA-N

Description

Description générale

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

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Actions biochimiques/physiologiques

Tenofovir disoproxil fumarate is a prodrug of tenofovir, a nucleotide analogue reverse transcriptase inhibitor (nRTI) that causes premature termination of DNA transcription. In a T cell line and primary blood lymphocytes, the antiviral activity of tenofovir disoproxil was shown to be more than 100-fold greater than tenofovir because of its rapid intracellular uptake. Tenofovir disoproxil fumarate has been used alone and in various combinations for the prevention and treatment of HIV/AIDS and chronic hepatitis B infections and is on the World Health Organization′s List of Essential Medicines.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAB2763 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: GHS08,GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H319,H373,H412
• Conseils de prudence: P260 - P264 - P273 - P280 - P305 + P351 + P338 - P314
• Classification des risques: Aquatic Chronic 3 - Eye Irrit. 2 - STOT RE 2
• Organes cibles: Bone,Kidney
• 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