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PHR1592

Tenofovir

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(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

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About This Item

Empirical Formula (Hill Notation):
C9H14N5O4P · H2O
CAS Number:
206184-49-8
Molecular Weight:
305.23
UNSPSC Code:
41116107
NACRES:
NA.24
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1643601

API family

tenofovir

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

[P](=O)(O)(O)CO[C@@H](C[n]1c2ncnc(c2nc1)N)C.O

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

InChI key

PINIEAOMWQJGBW-FYZOBXCZSA-N

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. 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.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP 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.
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.

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pictograms

Skull and crossbones
GHS06

signalword

Danger

hcodes

H301

Hazard Classifications

Acute Tox. 3 Oral

Storage Class

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

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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HPTLC method for the simultaneous estimation of emtricitabine and tenofovir in tablet dosage form
Joshi M, et al.
Indian Journal of Pharmaceutical Sciences, 71(1), 95-95 (2009)
Validated HPTLC method for the determination of tenofovir as bulk drug and in pharmaceutical dosage form
Pradeep K, et al.
Research Journal of Chemical Sciences, 1(7), 33-37 (2011)

Global Trade Item Number

SKUGTIN
PHR1592-1G04061834430490