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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

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About This Item

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

Key Documents

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Product Name

Tenofovir disoproxil fumarate, Pharmaceutical Secondary Standard; Certified Reference Material

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

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 key

VCMJCVGFSROFHV-WZGZYPNHSA-N

grade

certified reference material
pharmaceutical secondary standard

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

Quality Level

300

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Analysis Note

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

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.
Tenofovir disoproxil fumarate is a prodrug of tenofovir, a nucleotide analogue reverse transcriptase inhibitor (nRTI); anti-retroviral.

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

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.
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.

pictograms

Health hazardExclamation mark
GHS08,GHS07

signalword

Warning

Hazard Classifications

Aquatic Chronic 3 - Eye Irrit. 2 - STOT RE 2

target_organs

Bone,Kidney

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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