Dithranol BP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST CHLORIDE (Cl) 100 ppm LOSS ON DRYING 0.50% SULPHATED ASH 0.10% ELEMENTAL IMPURITIES:...
Gabapentin USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 2% SOLUTION 6.5 8 WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED EARLY-ELUTING...
Levothyroxine Sodium USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% SPECIFIC ROTATION -5� to -6� -5� to -6� WATER DETERMINATION 11.00% ORGANIC IMPURITIES, PROCEDURE 2 . . LIOTHYRONINE 1.00% MONOCHLOROTRIIODOTHYRONINE 0.15%...
Methylprednisolone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +97� to +105� +97� to +105� LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...
Medroxyprogesterone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +45� to +51� +45� to +51� LOSS ON DRYING 1.00% MEDROXYPROGESTRONE ACETATE[nRELATED COMPOUND A 0.50% ORGANIC IMPURITIES TO...
Pramoxine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 170� 174�C LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTD IDENTIFICATION TO PASS TEST RETEST...
Promethazine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 101.50% pH OF A 1 IN 20 SOLUTION 4 5 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS...
Pralidoxime Chloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% CHLORIDE CONTENT (DRIED BASIS) 20.2 20.80% LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.50% ORGANIC IMPURITIES: PYRIDIINE-2-ALDOXIME 0.50% PRALIDOXIME ANTI-ISOMER 2%...
Enalapril Maleate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]20 -41.0� to -43.5 -41.0� to -43.5 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES: LEAD (Pb)...
Diclofenac Sodium USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% COLOR OF SOLUTION TO PASS TEST TO PASS TEST CLARITY OF SOLUTION TO PASS TEST TO PASS TEST pH OF A...
Baclofen USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 3.00% RESIDUE ON IGNITION 0.30% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...
Monobenzone USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 117� 120�C LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS...
Triamcinolone Diacetate Micronized USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +39� to +45� +39� to +45� WATER DETERMINATION 6.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS...
Sodium Bisulfite Granular FCC
Test Specification Min Max ASSAY (SO[@2@]) 58.5 67.40% IRON (Fe) 0.01% LEAD (Pb) 2 mg/kg SELENIUM (Se) 5 mg/kg IDENTIFICATION (A) POSITIVE POSITIVE IDENTIFICATION (B) POSITIVE POSITIVE EXPIRATION DATE MANUFACTURE...
Omeprazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST LIMIT OF OMEPRAZOLE RELATED COMPOUNDS F AND G 350 PPM LOSS ON...
Fluorouracil USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% FLUOROURACIL RELATED COMPOUND F 0.25% UREA 0.20% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Meclofenamate Sodium USP
Test Specification Min Max ASSAY (C[@14@]H[@10@]Cl[@2@]NNaO[@2@]; ANHYDROUS BASIS) 97 103.00% WATER DETERMINATION 4.8 5.80% COPPER 0.00% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Ketoconazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] -1 to +1 -1 to +1 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...
Furosemide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST IDENTIFICATION TO...
Cyclobenzaprine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...
Clotrimazole 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 IMIDAZOLE 0.50% CLOTRIMAZOLE RELATED COMPOUND A 0.50%...
Cromolyn Sodium USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% ACIDITY OR ALKALINITY TO PASS TEST WATER DETERMINATION 10.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED OXALATE 0.35% RELATED COMPOUNDS 0.50% IDENTIFICATION...
Methacholine Chloride Crystal USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% IDENTIFICATION TO PASS TEST TO PASS TEST LOSS ON DRYING 1.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Betamethasone Dipropionate Micronized Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +63� to +70� +63� to +70� LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS...
Acyclovir USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% GUANINE 0.70% WATER DETERMINATION 6.00% ORDINARY IMPURITIES 1% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE...
Valproic Acid USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Loperamide Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % CHLORIDE (Cl) 13.52 - 14.20 % 13.52 - 14.20 % CHROMATOGRAPHIC PURITY TO PASS TEST...
Dextromethorphan USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% HEAVY METALS 0.00% N,N-DIMETHYLANILINE 0.00% PHENOLIC COMPOUNDS TO PASS TEST IDENTIFICATION TO PASS TEST...
Cyproheptadine Hydrochloride USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 100.50% WATER DETERMINATION 7 9.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...
Apomorphine Hydrochloride Hemihydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] -48� to -52� -48� to -52� LOSS ON DRYING 2 4.20% COLOR OF SOLUTION TO PASS TEST TO...
Terpin Hydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 100.50% WATER DETERMINATION 9 10.00% RESIDUE ON IGNITION 0.10% RESIDUAL TURPENTINE TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO...
Captopril USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.5 102.00% SPECIFIC ROTATION [a][@D@] -125 to -134 -125 to -134 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED...
Atenolol USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 152� 156.5� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% CHLORIDE (Cl) 0.10% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL...
Hydrocortisone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION @ 20 C +158� to +167� +158� to +167� LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ORGANIC IMPURITIES...
Hydroxyurea USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED AS REPORTED MOLYBDENUM (Mo) AS REPORTED AS...