Ipratropium Bromide USP Cyclic Polyamines Test Specification Min Max ASSAY

Test Specification Min Max ASSAY (ANHYDROUS BASIS) as ASCORBIC ACID 73

0009 meq SUBSTANCES DARKENED BY (H[@2@]SO[@4@]) TO PASS TEST TO PASS TEST FLUORESCENCE BACKGROUND[n(as QUININE SULFATE) 1 ppb HALOGENATED RESIDUE BY GC-ECD(AS HEP

5 pp LANTHANUM 19

30% CHROMATOGRAPHIC PURITY TO PASS TEST RESIDUE ON IGNITION 0

Ipratropium Bromide USP Cyclic Polyamines Test Specification Min Max ASSAYTest Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102. 00% pH of 10 % SOLUTION 5 7 WATER DETERMINATION 3. 9 4. 40% RESIDUE ON IGNITION 0. 10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IPRATROPIUM RELATED COMPOUND A TO PASS TEST TO PASS TEST ORGANIC IMPURITIES 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