Lansoprazole Enantiomer Excess & Absolute Configuration Determination Test Specification Min Max APPEARANCE

Test Specification Min Max APPEARANCE CLEAR LIQUID CLEAR LIQUID APPEARANCE CLEAR LIQUID CLEAR LIQUID VISCOSITY 4000 - 6000 cSt 4000 - 6000 cSt VISCOSITY 4000 - 6000 cSt 4000 - 6000 cSt

Test Specification Min Max ASSAY 95% SOLUBILITY TO PASS TEST TO PASS TEST UV ABSORPTION TO PASS TEST TO PASS TEST RETEST DATE

1N NaOH) 566 (381) nm 566 (381) nm LOSS ON DRYING @ 105 C 4%

Test Specification Min Max ASSAY (C[@3@]H[@7@]NO[@2@]S

Test Specification Min Max LOSS ON DRYING As Reported As Reported HEAVY METALS 5 PPM MICROBIAL LIMITS: ESCHERICHIA COLI NEGATIVE NEGATIVE SALMONELLA NEGATIVE NEGATIVE

Lansoprazole Enantiomer Excess & Absolute Configuration Determination Test Specification Min Max APPEARANCE