Nalbuphine Hydrochloride Acyclic Monoterpenes Test Specification Min Max ABSORPTION

Test Specification Min Max ABSORPTION MAX APPROX

00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH OF SOLUTION 4 6

01% SULFATE AND SULFITE (as SO[@4@]) 0

03% IRON 30 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST

Nalbuphine Hydrochloride Acyclic Monoterpenes Test Specification Min Max ABSORPTIONTest Specification Min Max ASSAY 98. 0 102. 0% 98. 0 102. 0% MELTING RANGE OF FREE BASE 228?? 235?? 228?? 235?? HEAVY METALS 0. 00% WATER 7. 50% IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE