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1 USP MICROBIAL LIMITS: TOTAL AEROBIC PLATE COUNT 100 cfu TOTAL YEAST AND MOLDS 20 cfu/ ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST
Test Specification Min Max ASSAY (TITRATION) 50 52
Test Specification Min Max ABSORPTION MAX Approx
00% IDENTIFICATION (A) SPECTRUM SPECTRUM IDENTIFICATION (B) RETENTION RETENTION IDENTIFICATION (C) RED PURPLE RED PURPLE IDENTIFICATION (D) WHITE WHITE EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS AS REPORTED
00% ALCOHOL CONTENT (CH3CH2OH) 79 85
Ipratropium Bromide BP EP size:1 KG 1 USP MICROBIAL LIMITS: TOTALTest Specification Min Max ASSAY (ANHYDROUS BASIS) 99. 0 100. 5 % 99. 0 100. 5 % APPEARANCE OF SOLUTION TO PASS TEST pH OF A 1% SOLUTION 5. 0 7. 5 5. 0 7. 5 OPTICAL ROTATION 0. 10 to+0. 10 0. 10 to+0. 10 WATER 3. 9 4. 4 % 3. 9 4. 4 % RELATED SUBSTANCES TO PASS TEST APO IPRATROPIUM 0. 50% SULPHATED ASH 0. 10% IDENTIFICATION TO PASS TEST EXPIRATION DATE RESIDUAL SOLVENTS TO PASS TEST
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