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Test Specification Min Max MICROBIAL LIMITS ABSENT ABSENT pH of a 2% SUSPENSION @ 25 C 9
MELTING RANGE 87 89
00% ACIDITY / ALKALINITY TO PASS TEST COMPLETENESS OF SOLUTION TO PASS TEST LOSS ON DRYING 2
Test Specification Min Max ASSAY vs
MES Monohydrate cGMP Manufactured Gastrointestinal APIs Test Specification Min Max MICROBIALTest 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
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