Methotrexate USP Sulfur Compounds (for Synthesis) Test Specification Min Max ASSAY

Test Specification Min Max ASSAY (PbO) 95

0 TRANSMITTANCE 95% LEAD (Pb) 5 ppm HEAVY METALS 10 ppm LOSS ON DRYING @ 105 C 0

Test Specification Min Max POTENCY (C[@22@]H[@24@][N[@2@]O[@8@]) 880 980 ug/mg CRYSTALLINITY TO PASS TEST TO PASS TEST pH OF SOLUTION 5 6

3 % EXPIRATION DATE

Methotrexate USP Sulfur Compounds (for Synthesis) Test Specification Min Max ASSAYTest Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102. 00% RELATED COMPOUNDS TO PASS TEST ENANTIOMERIC PURITY TO PASS TEST RESIDUE ON IGNITION 0. 10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED WATER DETERMINATION 12. 00% IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST