TestSpecificationMinMaxAPPEARANCE

Test Specification Min Max ASSAY (as ETHYL (Z)-9-OCTADECENOATE) TO PASS TEST TO PASS TEST PRESENCE OF ESTER TO PASS TEST TO PASS TEST IODINE VALUE 75 85 PEROXIDE VALUE 10...

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...

TestSpecificationMinMaxASSAY (by GC)99%99%

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% SPECIFIC ROTATION -1??to +1??/td> -1??to +1??/td> WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% ADRENALONE TO PASS TEST NOREPINEPHRINE 4.00% ELEMENTAL IMPURITIES:...

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 (C[@10@]H[@12@]CaN[@2@]Na[@2@]O[@8@]) 97 102.00% pH OF A 1 IN 100 SOLUTION 6.5 7.5 LEAD 4 mg/kg MAGNESIUM-CHELATING SUBSTANCES TO PASS TEST NITRILOTRIACETIC ACID 0.10% WATER DETERMINATION...

Test Specification Min Max ASSAY (C[@10@]H[@14@]O[@8@]N[@2@]Na[@2@]2H[@2@]O) 99.0 - 101.0 % 99.0 - 101.0 % pH OF A 5% SOLUTION @ 25[dC 4.0 - 6.0 4.0 - 6.0 INSOLUBLE MATTER 0.01%...

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...

TestSpecificationMinMaxAPPEARANCEEXPIRATION DATE

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) 92.0 - 103.0% 92.0 - 103.0% LOSS ON DRYING 1.50% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION...

TestSpecificationMinMaxSPECIFIC ROTATION, [a][@D@]20-46to -50WATER10%

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxASSAY98%APPEARANCECLEAR LIQUIDCLEAR LIQUID

TestSpecificationMinMaxAPPEARANCE

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.0 - 102.0 % 98.0 - 102.0 % CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST WATER 0.50% RESIDUE ON IGNITION 0.10% HEAVY...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxVISUAL TRANSITION INTERVALSpH 2.9 (red) topH 2.9 (red) toRETEST DATE

TestSpecificationMinMaxASSAY98%98%

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...

TestSpecificationMinMaxASSAY90%FDA LOT NUMBERIDENTIFICATIONTO PASS TESTAPPEARANCE

Test Specification Min Max ASSAY 90% VOLATILE MATTER (@ 135 C) 5% MATTER INSOLUBLE IN BOTH, TOLUENE AND WATER 0.50% ANILINE 0.20% 4-AMINOAZOBENZENE 0.10% 2-NAPHTHOL 0.20% 1-(PHENYLAZO)-2-NAPHTHOL 3% 1-{[2-(PHENYLAZO)PHENYL]AZO}-2-NAPHTHALENOL 2%...

TestSpecificationMinMaxFDA LOT NUMBERAPPEARANCEIDENTIFICATIONTO PASS TESTTO PASS TEST