MES Monohydrate cGMP Manufactured Gastrointestinal APIs Test Specification Min Max PURITY

Test Specification Min Max PURITY (GC) 98% MELTING POINT 76

542 ELEMENTAL IMPURITIES AS REPORTED HYDROCARBONS TO PASS TEST PHENOLS TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION DATE CERTIFIED HALAL DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST

30% LOSS ON DRYING 0

10% LEAD 0

Test Specification Min Max MICROBIAL LIMITS ABSENT ABSENT pH of a 2% SUSPENSION @ 25 C 9

MES Monohydrate cGMP Manufactured Gastrointestinal APIs Test Specification Min Max PURITYTest Specification Min Max ASSAY (TITRATION) 99. 50% pH OF A 5% SOLUTION 2. 5 4 pKa @ 25C 5. 95 6. 35 ABSORBANCE @ 260 nm (0. 1M in Water) 0. 04 AU ABSORBANCE @ 280 nm (0. 1M in Water) 0. 02 AU WATER (KF) 9% HEAVY METALS (as Pb) 5 ppm MICROBIAL LIMITS: TOTAL YEAST AND MOLDS 100 CFU g TOTAL AEROBIC MICROBIAL COUNT 100 CFU g ENDOTOXIN 50 EU g IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO