Primidone Suppository Base Excipients Test Specification Min Max ASSAY

Test Specification Min Max ASSAY (by GC) 97%

0% WATER 2

Test Specification Min Max MICROBIAL LIMITS: TOTAL PLATE COUNT 10000/g YEAST AND MOLD 300/g ESCHERICHIA COLI NEGATIVE SALMONELLA NEGATIVE RETEST DATE

00% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST

50% HEAVY METALS (JP) 10 ppm ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED AS REPORTED CHROMIUM (Cr) AS REPORTED AS REPORTED MOLYBDENUM (Mo) AS REPORTED AS REPORTED ARSENIC (As) 5 ppm ORGANIC MATTER TO PASS TEST TO PASS TEST SULFATES (SO[@4@]) 450 ppm IDENTIFICATION TO PASS TEST TO PASS TEST CERTIFIED HALAL RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST

Primidone Suppository Base Excipients Test Specification Min Max ASSAYTest Specification Min Max APPEARANCE