PHR1957

Tenofovir disoproxil fumarate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(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
• Empirical Formula (Hill Notation): C₁₉H₃₀N₅O₁₀P · C₄H₄O₄
• CAS Number: 202138-50-9
• Molecular Weight: 635.51
• MDL number: MFCD08141829
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1643656
• API family: tenofovir
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• application(s): pharmaceutical
• format: neat
• storage temp.: 2-8°C
• SMILES string: 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
• InChI key: VCMJCVGFSROFHV-WZGZYPNHSA-N

Description

General description

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.

Biochem/physiol Actions

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.

Analysis Note

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

Other Notes

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.

Footnote

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.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Warning
• Hazard Statements: H319,H373,H412
• Precautionary Statements: P260 - P264 - P273 - P280 - P305 + P351 + P338 - P314
• Hazard Classifications: Aquatic Chronic 3 - Eye Irrit. 2 - STOT RE 2
• Target Organs: Bone,Kidney
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable