Trazodone Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% TRAZODONE RELATED COMPOUND F 2.5 ??/g CYCLOPHOSPHAMIDE RELATED COMPOUND A 2.5 ??/g ORGANIC...
Timolol Maleate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 2% SOLUTION 3.8 4.3 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Trimethoprim Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 199?? 203?? LOSS ON DRYING 0.50% CHROMATOGRAPHIC IMPURITIES (TOTAL) TO PASS TEST RESIDUE ON IGNITION 0.10% IDENTIFICATION TO PASS...
Triamterene USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% ORGANIC IMPURITIES: TRIAMTERENE RELATED COMPOUND A 0.10% TRIAMTERENE RELATED COMPOUND B 0.15% TRIAMTERENE RELATED COMPOUND C 0.15%...
Sulfadiazine Powder USP
Test Specification Min Max ASSAY (C[@10@]H[@10@]N[@4@]O[@2@]S) 98 102.00% CLARITY AND COLOR OF SOLUTION TO PASS TEST ACIDITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES...
Streptomycin Sulfate USP
Test Specification Min Max POTENCY (DRIED BASIS) 650 - 850 ??/mg 650 - 850 ??/mg pH 4.5 - 7.0 4.5 - 7.0 LOSS ON DRYING 5.00% IDENTIFICATION TO PASS TEST...
Sodium DL-Lactate Solution 60 Percent USP
Test Specification Min Max ASSAY (C[@3@]H[@5@]NaO[@3@]) 58.8 61.20% pH OF SOLUTION @ 25[dC 5 9 CHLORIDE (Cl) 0.05% CITRATE, OXALATE, PHOSPHATE OR TARTRATE TO PASS TEST SULFATES (SO[@4@]) TO PASS...
Spironolactone USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION -41??to -45??/td> -41??to -45??/td> LOSS ON DRYING 0.50% MERCAPTO-COMPOUNDS TO PASS TEST ORDINARY IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES...
Sodium Valproate EP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO...
Scopolamine Hydrobromide Trihydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 102.00% SPECIFIC ROTATION -24??to -26??/td> -24??to -26??/td> pH (1 in 20 solution) 4 5.5 WATER DETERMINATION 13.00% RESIDUE ON IGNITION 0.10% ORGANIC...
Sulfadiazine Sodium USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% LOSS ON DRYING 0.50% SELENIUM (Se) 0.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF...
Selegiline Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE (WITHIN 2[dC) 141?? 145?? SPECIFIC ROTATION [a][@D@] -10.0??to -12??/td> -10.0??to -12??/td> CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST...
Sodium Polystyrene Sulfonate USP
Test Specification Min Max POTASSIUM EXCHANGE CAPACITY (Anhydrous Basis) 110 135 mg/g SODIUM CONTENT (DRIED BASIS) 9.4 11.50% WATER DETERMINATION 10.00% AMMONIUM SALTS TO PASS TEST ELEMENTAL IMPURITIES: LEAD (Pb)...
Simvastatin USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION +285??to +298??/td> +285??to +298??/td> LOSS ON DRYING 0.50% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST RESIDUE ON IGNITION...
Quinine Sulfate Dihydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 101.00% SPECIFIC ROTATION @25 C -235??to -245??/td> -235??to -245??/td> WATER DETERMINATION 4 5.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED CHLOROFORM-ALCOHOL-INSOLUBLE...
Quinidine Sulfate Dihydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 101.00% SPECIFIC ROTATION [a][@D@] +275??to +288??/td> +275??to +288??/td> WATER DETERMINATION 4 5.50% RESIDUE AFTER IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...
Ribavirin USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.9 101.50% SPECIFIC ROTATION [a][@D@] -33.5 to -37.0??/td> -33.5 to -37.0??/td> pH (1 in 50) 4 6.5 LOSS ON DRYING 0.50% ORGANIC IMPURITIES...
Tretinoin Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ISOTRETINOIN 5.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION...
Rifampin USP
Test Specification Min Max ASSAY (DRIED BASIS) 95 103.00% CRYSTALLINITY TO PASS TEST TO PASS TEST pH of a 1 % SUSPENSION 4.5 6.5 LOSS ON DRYING 2.00% RELATED SUBSTANCES...
Prednisone Anhydrous Micronized USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +167??to +175??/td> +167??to +175??/td> WATER DETERMINATION 1.00% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ORGANIC IMPURITIES TO PASS TEST ELEMENTAL...
Pyridoxine Hydrochloride USP
Test Specification Min Max ASSAY 98 102.00% CHLORIDE CONTENT 16.9 17.60% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED CADMIUM (Cd) AS...
Potassium Acetate Crystalline Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% pH OF A 5% SOLUTION @ 25[dC 7.5 8.5 LOSS ON DRYING 1.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED SODIUM 0.03%...
Podophyllum Resin USP
Test Specification Min Max ASSAY (HEXANE INSOLUBLE) 40 50.00% DISTINCTION FR. RESIN OF INDIAN PODOPHYLLUM TO PASS TEST RESIDUE AFTER IGNITION 1.50% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...
Potassium Citrate Monohydrate Granular USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% LOSS ON DRYING 3 6.00% ALKALINITY TO PASS TEST TARTRATE TO PASS TEST ELEMENTAL IMPURITIES: ARSENIC (As) AS REPORTED AS REPORTED...
Praziquantel USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.0% 98.5 - 101.0% IDENTIFICATION TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% PHOSPHATE 0.05%...
Perphenazine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST IDENTIFICATION TO...
Phentolamine Mesylate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SULFATE 0.20% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO...
Pyrazinamide USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 101.00% MELTING RANGE 188 191?? WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST...
Primaquine Phosphate USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 102.0 % 97.0 - 102.0 % LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS...
Progesterone Wettable Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% MELTING RANGE 126?? 131?? SPECIFIC ROTATION +175??to +183??/td> +175??to +183??/td> LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED AS...
Pyridostigmine Bromide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 100.5% 98.5 - 100.5% MELTING RANGE 154??- 157?? 154??- 157?? LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.10% ORDINARY IMPURITIES TO...
