Methoxsalen USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% MELTING RANGE 143� - 148�C 143� - 148�C WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED CHROMATOGRAPHIC IMPURITIES...
Mebendazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...
Ergotamine Tartrate (DEA List I Chemical) USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 100.50% SPECIFIC ROTATION [a][@D@] -155� to -165� -155� to -165� LOSS ON DRYING 5.00% RELATED ALKALOIDS TO PASS TEST ELEMENTAL IMPURITIES TO...
Ranitidine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.5 102.00% pH OF A 1 IN 100 SOLUTION 4.5 6 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.75% RESIDUE ON IGNITION...
Pyrimethamine USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% MELTING RANGE 238� 242�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORDINARY IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED...
Ipratropium Bromide BP EP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99.0 - 100.5 % 99.0 - 100.5 % APPEARANCE OF SOLUTION TO PASS TEST pH OF A 1% SOLUTION 5.0 - 7.5 5.0...
Chlorambucil USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% MELTING RANGE 65� 69�C WATER DETERMINATION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION...
Cefoperazone Sodium Antibacterial USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 870 - 1015 ug/mg 870 - 1015 ug/mg CRYSTALLINITY TO PASS TEST TO PASS TEST pH of a 1 in 4 Solution 4.5...
Calcium Gluceptate Hemiheptahydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 95.0 - 102.0 % 95.0 - 102.0 % pH OF A 1 IN 10 SOLUTION 6.0 - 8.0 6.0 - 8.0 LOSS ON...
Azathioprine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS...
Hydrocortisone Hemisuccinate Monohydrate USP
Test Specification Min Max ASSAY (C[@25@]H[@34@]O[@8@]) 97.0 - 103.0 % 97.0 - 103.0 % SPECIFIC ROTATION [a][@D@] +124 to +134 +124 to +134 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS...
Thioridazine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% MELTING RANGE (WITHIN 3�C) 159� 165�C pH OF A 1 IN 100 SOLUTION 4.2 5.2 LOSS ON DRYING 0.40% CHROMATOGRAPHIC IMPURITIES...
Dorzolamide Hydrochloride USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 101.00% HEAVY METALS 10 ppm LIMIT OF DORAZOLAMIDE HYDROCHLORIDE RELATED COMPOUND A 0.50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST RESIDUE...
Methylprednisolone Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +79 to +86 +79 to +86 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% RESIDUE ON IGNITION...
Betamethasone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +120� to +128� +120� to +128� WATER DETERMINATION 4.00% RESIDUE ON IGNITION 0.20% ORDINARY IMPURITIES TO PASS TEST...
Prednisolone Anhydrous Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +97 to +103 +97 to +103 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00%...
Acetaminophen Granular USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: PLATINUM (Pt) AS REPORTED AS REPORTED FREE p-AMINOPHENOL 0.01% ORGANIC IMPURITIES TO PASS TEST TO...
Betamethasone Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +118 to +126 +118 to +126 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ORDINARY IMPURITIES TO PASS...
Chlorpheniramine Maleate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]25 -0.10 to +0.10� -0.10 to +0.10� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS...
Naproxen Sodium USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION -15.3� to -17.0 -15.3� to -17.0 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% ELEMENTAL...
Manganese Chloride Tetrahydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% pH OF A 1 IN 20 SOLUTION 3.5 6 LOSS ON DRYING 36 38.50% INSOLUBLE MATTER 0.01% SULFATE 0.01% SUBS. NOT...
Dexamethasone Sodium Phosphate Powder USP
Test Specification Min Max ASSAY (Anhydrous Solvent-free Basis) 97 102.20% SPECIFIC ROTATION (Anhydrous Solvent-free Basis) +74� +82� pH (1% AQUEOUS SOLUTION) 7.5 10.5 WATER DETERMINATION 10.00% ALCOHOL 1.50% PHOSPHATE IONS...
Potassium Bicarbonate Granular USP
Test Specification Min Max ASSAY (KHCO[@3@]) 99.5 101.50% LOSS ON DRYING (OVER SILICA) 0.30% NORMAL CARBONATE 2.50% ELEMENTAL IMPURITIES: COBALT (Co) AS REPORTED ANTIMONY (Sb) AS REPORTED TIN (Sn) AS...
Methenamine USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.01% SULFATE TO PASS TEST AMMONIUM SALTS TO PASS TEST ELEMENTAL...
Thiabendazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE 296� 303�C CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SELENIUM (Se) 0.00% ELEMENTAL...
Alprostadil USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95 105.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% FOREIGN PROSTAGLANDINS, TEST 1 TO PASS TEST TO PASS TEST FOREIGN PROSTAGLANDINS, TEST 2...
Vancomycin Hydrochloride USP
Test Specification Min Max POTENCY (AS VANCOMYCIN) 900 �g/mg pH OF A 50 mg/ml SOLUTION @ 25[dC 2.5 4.5 COMPOSTION OF VANCOMYCIN TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...
Ursodiol USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% MELTING RANGE 200 205�C SPECIFIC ROTATION [a][@D@] +57� to +62� +57� to +62� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...
Verapamil Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 5% SOLUTION 4.5 6.5 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...
Theophylline Anhydrous USP
Test Specification Min Max ASSAY 97 102.00% LOSS ON DRYING @ 105 C 0.50% ORGANIC IMPURITIES: . . THEOPHYLLINE RELATED COMPOUND C 0.10% THEOPHYLLINE RELATED COMPOUND B 0.10% THEOPHYLLINE RELATED...
Triamcinolone USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 102.0 % 97.0 - 102.0 % SPECIFIC ROTATION [a][@D@] +65 to +72 +65 to +72 LOSS ON DRYING 2.00% RESIDUE ON...
Triamcinolone Hexacetonide USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% OPTICAL ROTATION +91 to +98 +91 to +98 LOSS ON DRYING 2.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED TRIAMCINOLONE ACETONIDE 1.00%...
Tamsulosin Hydrochloride EP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST ENANTIOMERIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% SULFATED...
Tylosin Tartrate For Veterinary Use BP
Test Specification Min Max POTENCY (DRIED BASIS) 800 IU/mg pH OF A 2.5% AQUEOUS SOLUTION 5.0 - 7.2 5.0 - 7.2 COMPOSITION TO PASS TEST TO PASS TEST TYRAMINE 0.35%...