Lovastatin USP Fluorenes & Fluorenones 5 % ALKALIES AND ALKALINE

5 % ALKALIES AND ALKALINE EARTHS TO PASS TEST FLUORIDE 0

5 RESIDUE ON IGNITION 40 - 50 % 40 - 50 % RESIDUE ON IGNITION 40 - 50 % 40 - 50 % SPECIFIC ROTATION [a][@D@] +75

Test Specification Min Max APPEARANCE White to slight White to slight SOLUBILITY TO PASS TEST TO PASS TEST SPECIFIC ROTATION +192 to +203 +192 to +203 LOSS ON DRYING 12% SULFATED ASH 0

Pt-Co 15 WATER (w/w) 0

Lovastatin USP Fluorenes & Fluorenones 5 % ALKALIES AND ALKALINETest Specification Min Max ASSAY (DRIED BASIS) 98. 5 101. 0 % 98. 5 101. 0 % SPECIFIC ROTATION +324 to +338 +324 to +338 LOSS ON DRYING 0. 30% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 0. 20% HEAVY METALS 0. 00% LOVASTATIN RELATED COMPOUND A 0. 50% IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST