Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED CHROMATOGRAPHIC IMPURITIES TO PASS TEST IBUPROFEN RELATED COMPOUND C 0.10%...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 100.50% SPECIFIC ROTATION [a][@D@] -24??to -29??/td> -24??to -29??/td> WATER DETERMINATION 2.5 5.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL...

Test Specification Min Max ASSAY 98.0-101.0 % 98.0-101.0 % MELTING RANGE 106 - 109 C 106 - 109 C SPECIFIC ROTATION, [a][@D@](C = 1) -20 to-23 -20 to-23 LOSS ON...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH (1 in 50) 3.5 4.2 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED HYDRAZINE 0.00% ORGANIC...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% MELTING RANGE 120??- 124?? 120??- 124?? SPECIFIC ROTATION +58??to +64??/td> +58??to +64??/td> WATER DETERMINATION 0.10% FREE n-CAPROIC ACID 0.58% ORDINARY IMPURITIES...

Test Specification Min Max ASSAY 97 102.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH OF SOLUTION 4 6.5 LOSS ON DRYING 0.50% IMPURITY E 0.50% RELATED SUBSTANCES...

Test Specification Min Max APPEARANCE White or almost White or almost ASSAY (DRIED SUBSTANCE) 99.0 - 101.0 % 99.0 - 101.0 % RELATED SUBSTANCES TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] 126?? 138??/td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 3.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.40% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS TO PASS TEST IDENTIFICATION TO...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST WATER DETERMINATION 0.25% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO PASS TEST EXPIRATION DATE...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ERYTHRO ISOMER 0.40% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.30% ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST SPECIFIC OPTICAL ROTATION +354??to +364??/td> +354??to +364??/td> ACIDITY TO PASS TEST TO...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION +81??to +89??/td> +81??to +89??/td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% COMPLETENESS OF SOLUTION TO PASS TEST MELTING RANGE 180?? 186?? SPECIFIC ROTATION [a][@D@] -28.0??to-29.5 -28.0??to-29.5 LOSS ON DRYING 1.00% IDENTIFICATION TO...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +98??to +108??/td> +98??to +108??/td> LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (C[@18@]H[@22@]O[@2@]; DRIED BASIS) 97 103.00% CLARITY OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a]D25 +158??to +165??/td> +158??to +165??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% MELTING RANGE 147 152?? LOSS ON DRYING 0.50% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ADRENALONE TO PASS TEST NOREPINEPHRINE BITARTRATE 4.00% ELEMENTAL...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% COMPLETENESS OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a]D25 +54??to +62??/td> +54??to +62??/td> CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% EQUIVALENT WEIGHT (DRIED BASIS) 294 309 RESIDUE ON IGNITION 0.10% LOSS ON DRYING 0.25% HEAVY METALS 0.00% TOLUENE EXTRACTIVES 2.00% IDENTIFICATION...

Test Specification Min Max ASSAY 96 98.00% SPECIFIC GRAVITY @ 25[dC 0.713 0.716 ACIDITY (as CH[@3@]COOH) 0.00% NONVOLATILE RESIDUE 0.00% ALDEHYDE TO PASS TEST PEROXIDE 0.3 ppm LOW BOILING HYDROCARBONS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 600 ug/g 600 ug/g CRYSTALLINITY TO PASS TEST TO PASS TEST WATER 4.00% FREE ERYTHROMYCIN 3.00% IDENTIFICATION TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a]D25 +39.5 to +43.0??/td> +39.5 to +43.0??/td> pH OF A 1% SOLUTION 4 5 LOSS ON DRYING 0.50% RESIDUE...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +82??to +88??/td> +82??to +88??/td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.40% RESIDUE ON IGNITION 0.10% ELEMENTAL...

Test Specification Min Max ASSAY 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] +110??to +116??/td> +110??to +116??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.50% LOSS ON DRYING 0.30% CHROMATOGRAPHIC PURITY TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES AS REPORTED RESIDUE ON IGNITION 0.10% IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE...

Test Specification Min Max ASSAY 98 102.00% MELTING RANGE 69??- 72?? 69??- 72?? RESIDUE ON IGNITION 0.10% SELENIUM 30 ppm IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE...