Test Specification Min Max ASSAY 1.62 MIU/g 1.62 MIU/g ABSORBANCE RATIO @ 325 nm 0.85 ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED PALLADIUM (Pd) AS REPORTED AS REPORTED IDENTIFICATION...
Test Specification Min Max ASSAY (C[@7@]H[@4@]NNaO[@3@]S; ANHYDROUS BASIS) 98 101.00% ALKALINITY TO PASS TEST BENZOATE AND SALICYLATE TO PASS TEST LEAD 2 mg/kg READILY CARBONIZABLE SUBSTANCES TO PASS TEST SELENIUM...
Test Specification Min Max THEOPHYLLINE (ANHYDROUS BASIS) 84 87.40% ETHYLENEDIAMINE (ANHYDROUS BASIS) 13.5 15.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS...
Test Specification Min Max ASSAY 98.5 102.00% SPECIFIC ROTATION [a][@D@] +18.5 to +22.5� +18.5 to +22.5� CHLORIDE (Cl) 0.07% SULFATE (SO[@4@]) 0.12% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED SUCROSE AND...
Test Specification Min Max ASSAY (C[@6@]H[@10@]CaO[@6@]) 98.0 - 101.0 % 98.0 - 101.0 % LOSS ON DRYING 5.0 - 8.0 % 5.0 - 8.0 % ACIDITY (as LACTIC ACID) 0.45%...
Test Specification Min Max ASSAY 98.0 - 101.5 % 98.0 - 101.5 % pH 5.5 - 7.0 5.5 - 7.0 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% RESIDUE...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 101.50% pH OF 0.1% SOLUTION 5.5 6.5 OPTICAL ROTATION -0.10� to +0.10 -0.10� to +0.10 WATER 4 5.00% RELATED SUBSTANCES TO PASS...
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE WITHIN 3.0 C WITHIN 3.0 C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% VOLATILE RELATED COMPOUNDS TO PASS...
Test Specification Min Max ASSAY (KETONES AS CARVONE ; BY VOLUME) 50.00% 50.00% ANGULAR ROTATION +70 to +80 +70 to +80 REFRACTIVE INDEX @ 20[dC 1.484- 1.488 1.484- 1.488 SOLUBILITY...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 199� 203�C LOSS ON DRYING 0.50% CHROMATOGRAPHIC PURITY TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: NICKEL (Ni)...
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% HEAVY METALS 0.00% SELENIUM 0.00% IDENTIFICATION TO...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SILVER CONTENT 29.3 30.50% LOSS ON DRYING 0.50% NITRATE 0.10% ORGANIC IMPURITIES . . SULFANILIC ACID 0.30% 2-AMINO-2-METHYL-1-PROPANOL 0.30% ACETYLSULFADIAZINE 0.20%...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 - 101.5 % 98.5 - 101.5 % pH OF A 1 IN 100 SOLUTION 4.5 6 WATER DETERMINATION 4 6.00% CHROMATOGRAPHIC PURITY...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION +0.2� to -0.2� +0.2� to -0.2� pH OF A 1% SOLUTION 4 5 LOSS ON DRYING 0.50% RESIDUE ON...
Test Specification Min Max ANHYDROUS ALUMINUM CHLOROHYDRATE AS REPORTED AS REPORTED CONTENT OF ALUMINUM AS REPORTED AS REPORTED CONTENT OF CHLORIDE AS REPORTED AS REPORTED ALUMINUM/CHLORIDE ATOMIC RATIO 1.91:1 2.10:1...
Test Specification Min Max ASSAY (DRIED BASIS) 99 102.00% MELTING RANGE 64.5 68.5�C SPECIFIC ROTATION [a][@D@] -0.05 to +0.05� -0.05 to +0.05� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...
Test Specification Min Max ASSAY 97.5 101.50% pH OF A 1% SOLUTION 8 9 MONOETHANOLAMINE 223 230 mg/g RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS...
Test Specification Min Max ASSAY (AS NITROGEN; DRIED BASIS) 26 28.00% COLOR AND CLARITY OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 1% SOLUTION 6 7.5 LOSS...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 1 % SOLUTION @ 25[dC 5.2 6.5 WATER DETERMINATION 3.5 5.50% RESIDUE ON IGNITION 0.10% N,N-DIMETHYLANILINE 0.00% PHENOLIC...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]20 +6.5� to+10.5� +6.5� to+10.5� pH OF A 1 IN 10 SOLUTION 6 7 LOSS ON DRYING 0.50% RESIDUE...