Levocarnitine Free Base USP Solvents for HPLC & Spectrophotometry 037 LEAD (Pb) 1 mg/kg

037 LEAD (Pb) 1 mg/kg RESIDUE ON IGNITION 0

Test Specification Min Max APPEARANCE WHITE FLAKE WHITE FLAKE SAPONIFICATION NUMBER 112

15% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION (A) TO PASS TEST TO PASS TEST IDENTIFICATION (B) TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST

50% MICROBIAL LIMITS: TOTAL PLATE COUNT 1000/g YEAST AND MOLD 30/g COLIFORMS 3/g ESCHERICHIA COLI Negative SALMONELLA Negative IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE

Test Specification Min Max COBALT (Co) 70

Levocarnitine Free Base USP Solvents for HPLC & Spectrophotometry 037 LEAD (Pb) 1 mg/kgTest Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103. 00% pH 5. 5 9. 5 WATER DETERMINATION 4. 00% RESIDUE ON IGNITION 0. 50% CHLORIDE 0. 40% POTASSIUM 0. 20% SODIUM 0. 10% ENANTIOMERIC PURITY (as D CARNITINE) 0. 20% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST