Appearance

A    White to off white crystalline powder

White crystalline  powder

Solubility

Freely soluble in DMF and in methanol,sparingly soluble in water

Conform

Identification

A).By IR: Positive

Conform

B).By HPLC: Positive

Conform

Residue on ignition

0.2% max

complies

Water(By K.F)

1.0% max

0.4%

Heavy metals

20ppm max

Conform

Related Substance

(by HPLC)

a(Tenofovir): 0.15% max

Not detected

b(Adenine): 0.15% max

Not detected

c(Tenofovir isoproxil monoester): 1.0% max

0.29%

d(Tenofovir Disoproxil ethyl ester):0.15 max

Not detected

e(Tenofovir isopropyl isoproxil ): 0.3% max

Not detected

f(Tenofovir Disoproxil carbamate):0.15% max

Not detected

g(Tenofovir Disoproxil Dimer):0.15%

Not detected

Any Individual unspecified impuriy:0.1%

0.09%

Total impurity: 2.0% max

0.40%

Enantiomeric Purity

1.0% max

Not detected

Tenofovir Disoproxil Related compound B

 5PPM max

Not detected

Fumaric Acid

17.5~19.0%

18.03%

Residual solvents

Ethanol: 5000ug/g max

1159ug/g

Isopropyl alcohol: 5000ug/g max

1077ug/g

Methylene chloride:600ug/g max

Not detected

NMP: 530ug/g max

Not detected

Assay (on anhydrous basis)

98.0% to 102.0%

99.25%