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6-DIMETHYLANILINE 20 ppm ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST
Test Specification Min Max MOISTURE (KF) 15% MICROBIAL LIMITS: TOTAL PLATE COUNT 5000 CFU/g YEAST AND MOLD 100 CFU/g ESCHERICHIA COLI NEGATIVE SALMONELLA NEGATIVE
5 % OPTICAL ROTATION
SPECIFIC ROTATION
Omeprazole Magnesium EP Tonicity Agent Excipients 6-DIMETHYLANILINE 20 ppm ORGANIC IMPURITIESTest Specification Min Max ASSAY (ANHYDROUS BASIS) 97. 5 102. 00% MAGNESIUM (ANHYDROUS BASIS) 3. 3 355% WATER 7 10. 00% ABSORBANCE @ 440 nm 0. 1 RELATED SUBSTANCES TO PASS TEST TO PASS TEST RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST
