Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE 197 203?? LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS...
Test Specification Min Max POTENCY (CHYMOTRYPSIN; DRIED BASIS) 1000 USP units/m 1000 USP units/m ASSAY (OF LABELED POTENCY) 90.0 - 110.0 % 90.0 - 110.0 % MICROBIAL LIMITS: TO PASS...
Test Specification Min Max pH of a 1 % Dispersion 5 7 DEGREE OF SUBSTITUTION (DRIED BASIS) 0.6 0.85 RESIDUE ON IGNITION 14 28.00% SETTLING VOLUME TO PASS TEST LOSS...
Test Specification Min Max ASSAY (CrCl[@3@][-6H[@2@]O) 98 101.00% INSOLUBLE MATTER 0.01% SUBSTANCES NOT Pptd BY NH[@4@]OH (as SO[@4@]) 0.20% SULFATE 0.01% IRON (Fe) 0.01% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] +5.7??to +6.8??/td> +5.7??to +6.8??/td> LOSS ON DRYING 8 12.00% RELATED COMPOUNDS TO PASS TEST TO PASS TEST RESIDUE...
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +208??to +217??/td> +208??to +217??/td> LOSS ON DRYING 1.00% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ORGANIC IMPURITIES TO PASS TEST...
Test Specification Min Max RESIDUE ON IGNITION 2.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO...
Test Specification Min Max SOLUBILITY (in H[@2@]0) TO PASS TEST TO PASS TEST ROTATIONAL VISCOSITY OF A 1.5 % SOLUTION @ 75?? 5 cps LOSS ON DRYING 12.50% MICROBIAL LIMITS...
Test Specification Min Max ASSAY(Cascaroside A;Dried B.):Total Hydroxyanthracene 20.00% CASCAROSIDE (% of Total Hydoxyanthracene Derivates) 80% LOSS ON DRYING 10.00% RESIDUE ON IGNITION 4.00% HEAVY METALS 0.00% IDENTIFICATION TO PASS...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 100.50% pH OF A 1 IN 20 SOLUTION 6.3 9.6 WATER 7.00% FLUORIDE (F) 0.01% ARSENIC (As) 3 ppm LEAD (Pb) 0.00%...
Test Specification Min Max SPECIFIC GRAVITY @ 25?? 0.87 0.885 LIMIT OF NONVOLATILE RESIDUE (w/v) TO PASS TEST TO PASS TEST ALCOHOL DETERMINATION (CH[@3@]CH[@2@]OH) 74 80.00% ELEMENTAL IMPURITIES AS REPORTED...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99.5 100.50% CONGEALING RANGE 121?? 123?? WATER DETERMINATION 0.70% READILY CARBONIZABLE SUBSTANCES TO PASS TEST TO PASS TEST RESIDUE ON IGNITION (SULFATED ASH)...
Test Specification Min Max ASSAY (ALKALOIDS of BELLADONNA LEAF) 27 33 mg/100 ALCOHOL DETERMINATION 65 70.00% IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE RESIDUAL SOLVENTS TO PASS TEST...
Test Specification Min Max ASSAY (ALKALOIDS of BELLADONNA LEAF) 1.15 - 1.35 % 1.15 - 1.35 % IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE RESIDUAL SOLVENTS TO PASS...
Test Specification Min Max ASSAY 97.5 100.50% pH OF AN AQUEOUS SUSPENSION 3.5 10 SULFIDE (S) 0.5 ??/g ACID-SOLUBLE SUBSTANCES 0.30% SOLUBLE BARIUM SALTS 0.00% ELEMENTAL IMPURITIES: LEAD (Pb) AS...
Test Specification Min Max POTENCY (DRIED BASIS) 65 U/mg COMPOSITION OF BACITRACIN TO PASS TEST TO PASS TEST pH OF A 10,000 U/ml SOLUTION @ 25?? 5.5 7.5 LOSS ON...
Test Specification Min Max ASSAY (H[@3@]BO[@3@]) 99.5 100.50% pH of a 3.3 % Solution 3.8 4.8 SOLUBILITY IN ALCOHOL TO PASS TEST TO PASS TEST COMPLETENESS OF SOLUTION TO PASS...
Test Specification Min Max ASSAY 98 102.00% COLOR OF SOLUTION TO PASS TEST ACIDITY TO PASS TEST RESIDUE ON IGNITION 0.10% RELATED SUBSTANCES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED...
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +75??to +82??/td> +75??to +82??/td> CHROMATOGRAPHIC IMPURITIES TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +99??to +105??/td> +99??to +105??/td> WATER DETERMINATION 10.00% PHOSPHATE IONS 1.00% FREE BETAMETHASONE 1.00% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION...
Test Specification Min Max ASSAY 99 100.50% SPECIFIC GRAVITY @ 25[dC 1.116 1.12 CONGEALING TEMPERATURE 18.0?? REFRACTIVE INDEX @ 20[dC 1.568 1.57 ACIDITY TO PASS TEST ALDEHYDE 0.05% ELEMENTAL IMPURITIES...
Test Specification Min Max ASSAY (BENZOYL PEROXIDE) 70 80.00% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS...
Test Specification Min Max TOTAL ALKYLBENZYLDIMETHYLAMMONIUM CHLORIDE (ANHYD. BASIS) 97 103.00% RATIO OF ALKYL COMPONENTS TO PASS TEST TO PASS TEST ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST...
Test Specification Min Max ASSAY (DRIED BASIS) 97.5 102.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST EPIMER A TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% ELEMENTAL...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% RELATED SUBSTANCES TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% SULPHATED ASH 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Test Specification Min Max ASSAY (Bi) 49% 54% ARSENIC 10 ??/g NITRATE TO PASS TEST TO PASS TEST COPPER 10 ??/g LEAD 10 ??/g SILVER 10 ??/g SOLUBLE BISMUTH 40...
Test Specification Min Max ASSAY (DRIED BASIS) 97.6 - 100.7% 97.6 - 100.7% LOSS ON DRYING 1.00% CHLORIDE (Cl) 0.05% ALKALIES AND ALKALINE EARTHS 1.00% NITRATE (NO[@3@]) 0.40% SILVER (Ag)...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 100.50% pH of a 1 in 4 Solution 0.8 1.2 WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS...
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +88??to +94??/td> +88??to +94??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO...
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 100.5% 98.0 - 100.5% MELTING RANGE 141??- 148?? 141??- 148?? LOSS ON DRYING 5.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS...
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% CONGEALING TEMPERATURE 62?? 62?? LOSS ON DRYING 2.00% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE...
Test Specification Min Max ASSAY [Al[@2@](SO[@4@])[@3@]] 54 59.00% pH OF A 1 IN 20 SOLUTION 2.9 2.9 WATER DETERMINATION 41 46.00% ELEMENTAL IMPURITIES AS REPORTED ALKALIES AND ALKALINE EARTHS 0.40%...
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% LOSS ON DRYING 43 46.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IRON (Fe) TO PASS TEST TO PASS TEST IDENTIFICATION TO...
Test Specification Min Max ASSAY 99 103.00% ACIDITY / ALKALINITY TO PASS TEST COMPLETENESS OF SOLUTION TO PASS TEST LOSS ON DRYING 2.70% ARSENIC (As) 0.02% LEAD (Pb) 0.00% ELEMENTAL...
Test Specification Min Max ASSAY (DRIED BASIS) 99.5 100.50% pH OF A 5% SOLUTION @ 25[dC 4.6 6 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...