PHR1592

Tenofovir

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : [[(1R)-2-(6-Amino-9H-purin-9-yl)-1-methylethoxy]methyl]phosphonic acid monohydrate, 1-(6-Aminopurin-9-yl) propan-2-yl-oxymethylphosphonic acid, TEN
• Formule empirique (notation de Hill): C₉H₁₄N₅O₄P · H₂O
• Numéro CAS: 206184-49-8
• Poids moléculaire : 305.23
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to USP 1643601
• Famille d'API: tenofovir
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 1 g
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-8°C
• InChI: 1S/C9H14N5O4P.H2O/c1-6(18-5-19(15,16)17)2-14-4-13-7-8(10)11-3-12-9(7)14;/h3-4,6H,2,5H2,1H3,(H2,10,11,12)(H2,15,16,17);1H2/t6-;/m1./s1
• Clé InChI: PINIEAOMWQJGBW-FYZOBXCZSA-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. Tenofovir is a nucleotide analog reverse transcriptase inhibitor, and is widely used as an antiretroviral agent, for the treatment of HIV infection.

Application

Tenofovir may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using high-performance thin layer chromatography (HPTLC) technique.

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.

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 LRAC3475 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: GHS06
• Mention d'avertissement: Danger
• Mentions de danger: H301
• Conseils de prudence: P264 - P270 - P301 + P310 - P405 - P501
• Classification des risques: Acute Tox. 3 Oral
• Code de la classe de stockage: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable