Butyl Alcohol NF Suppository Base Excipients Test Specification Min Max APPEARANCE

Test Specification Min Max APPEARANCE YELLOWISH WHITE YELLOWISH WHITE IODINE VALUE 33 - 42 33 - 42 SAPONIFICATION VALUE 188 - 198 188 - 198 FREE FATTY ACIDS 0

Test Specification Min Max ABSORPTION MAX 503 513 nm ABSORPTION MAX

0100 +/- 0

9 (yellow)

Test Specification Min Max APPEARANCE CLEAR COLORLESS CLEAR COLORLESS

Butyl Alcohol NF Suppository Base Excipients Test Specification Min Max APPEARANCETest Specification Min Max ASSAY 99. 50% ACIDITY TO PASS TEST TO PASS TEST WATER DETERMINATION 0. 10% NONVOLATILE RESIDUE 0. 00% BUTYRALDEHYDE,2 BUTANOL,ISOBUTYL ALCOHOL (2 METHYL 1 PROPANOL) AND BUTYL ETHER TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST