Reserpine USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 101.00% LOSS ON DRYING @ 60�C 0.50% RESIDUE AFTER IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO...
Dantrolene Sodium USP
Test Specification Min Max ASSAY (FREE ACID FORM; ANHYDROUS BASIS) 90 96.00% WATER DETERMINATION 14.5 17.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED DANTROLENE RELATED COMPOUND A 0.15% ORGANIC IMPURITIES TO...
Finasteride USP
Test Specification Min Max ASSAY (C[@23@]H[@36@]N[@2@]O[@2@]; ANHYDROUS BASIS) 98.5 101.00% SPECIFIC ROTATION -56.0 to -60.0� -56.0 to -60.0� CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST WATER DETERMINATION 0.30% RESIDUE...
Fenofibrate BP EP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ACIDITY TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST...
Lamotrigine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% HEAVY METALS 10 ppm ORGANIC IMPURITIES TO PASS TEST TO PASS TEST LAMOTRIGINE...
Anastrozole USP
Test Specification Min Max ASSAY 98 102.00% HEAVY METALS 10 ppm ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% WATER DETERMINATION 0.30% IDENTIFICATION TO PASS TEST RESIDUAL SOLVENTS TO...
Ciclopirox Olamine USP
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...
Metoprolol Tartrate USP
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...
Acetazolamide USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% CHLORIDE 0.01% SULFATE 0.04% SELENIUM 30 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED SILVER...
Minoxidil Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 0.50% ORGANIC IMPURITIES 1.50% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION SPECTRUM MATCHES SPECTRUM...
Lidocaine USP
Test Specification Min Max ASSAY 97.5 102.50% CHLORIDE (Cl) 0.00% RESIDUE ON IGNITION 0.10% SULFATE 0.10% ORGANIC IMPURITIES: LIDOCAINE RELATED COMPOUND H 0.10% 2,6- DIMETHYLANILINE 0.01% ANY UNSPECIFIED IMPURITY 0.10%...
Cupric Sulfate Pentahydrate Granular USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 100.50% LOSS ON DRYING 33 36.50% SODIUM (Na) 0.02% POTASSIUM (K) 0.01% CALCIUM (Ca) 0.01% IRON (Fe) 0.00% NICKEL (Ni) 0.01% ELEMENTAL...
Hexachlorophene USP
Test Specification Min Max ASSAY (C[@13@]H[@6@]Cl[@6@]O[@2@]) 98.0 - 100.5 % 98.0 - 100.5 % MELTING POINT 161 - 167 C 161 - 167 C LOSS ON DRYING 1.00% RESIDUE ON...
Fluticasone Propionate USP
Test Specification Min Max ASSAY (ANHYDROUS, SOLVENT FREE BASIS) 98 101.00% SPECIFIC ROTATION +32� to +36� +32� to +36� ACETONE 1.00% WATER DETERMINATION 0.20% ORGANIC IMPURITIES TO PASS TEST TO...
Dyphylline USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 160� 164�C pH OF A 1 IN 100 SOLUTION 5.6 7.5 RESIDUE ON IGNITION 0.15% CHLORIDE 0.04% SULFATE 0.01%...
Sulfathiazole Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% MELTING RANGE 200� - 204�C 200� - 204�C ACIDITY TO PASS TEST TO PASS TEST LOSS ON...
Primidone USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS...
Nifedipine Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED PERCHLORIC ACID TITRATION TO PASS TEST TO...
Ketorolac Tromethamine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% pH OF A 1 IN 100 SOLUTION 5.7 6.7 LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION...
Danazol USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION +21� to +27� +21� to +27� CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 2.00% ELEMENTAL IMPURITIES AS REPORTED...
Diethylstilbestrol USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 100.5% 97.0 - 100.5% MELTING RANGE (WITHIN 4�C) 169� - 175�C 169� - 175�C ACIDITY OR ALKALINITY TO PASS TEST LOSS...
Ivermectin For Vet Use USP
Test Specification Min Max ASSAY (Sum of H[@2@]B[@1a@] and H[@2@]B[@1b@]; Dried, Alcohol & 95 102.00% & Formamide free Basis) RATIO (H[@2@]B[@1a@]/H[@2@]B[@1a@] + H[@2@]B[@1b@] 90% SPECIFIC ROTATION -17� to -20� -17�...
Guaifenesin USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% ORGANIC IMPURITIES TO PASS TEST LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST CERTIFIED HALAL RETEST DATE...
Oxtriphylline USP
Test Specification Min Max ASSAY (DRIED BASIS) 61.7- 65.5 % 61.7- 65.5 % CHOLINE 652 - 693 mg/g 652 - 693 mg/g MELTING RANGE 185 - 189 C 185 -...
Albuterol Sulfate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 101.00% CHROMATOGRAPHIC PURITY TO PASS TEST WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS...
Ethambutol Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 100.5 % 98.0 - 100.5 % SPECIFIC ROTATION +6.0�to +6.7� +6.0�to +6.7� AMINOBUTANOL 1.00% HEAVY METALS 20 ppm TOTAL STEREOISOMERS 4.00%...
Meloxicam USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...
Trifluoperazine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 -101.0 % 98.0 -101.0 % pH OF A 1 IN 20 SOLUTION 1.7 - 2.6 1.7 - 2.6 LOSS ON DRYING 1.50%...
Paclitaxel USP
Test Specification Min Max ASSAY (ANHYDROUS, SOLVENT-FREE BASIS) 97 102.00% SPECIFIC ROTATION, [a][@D@]25 -49.0� to -55.0 -49.0� to -55.0 WATER DETERMINATION 4.00% RESIDUE ON IGNITION 0.20% HEAVY METALS 0.00% BACTERIAL...
Cefixime Hydrated USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 950 1030 ug/mg IDENTIFICATION TO PASS TEST TO PASS TEST OPTICAL ROTATION -75� to -88� -75� to -88� CRYSTALLINITY TO PASS TEST TO...
Sulfacetamide Sodium Monohydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 100.50% pH OF A 5% SOLUTION @ 25[dC 8 9.5 SELENIUM (Se) 30 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED WATER DETERMINATION...
Doxycycline Hyclate USP
Test Specification Min Max POTENCY (C[@22@]H[@24@][N[@2@]O[@8@]) 800 920 �g/m CRYSTALLINITY TO PASS TEST TO PASS TEST pH OF A 10 mg/ml SOLUTION 2 3 WATER DETERMINATION 1.4 2.80% ETHANOL 4.3...