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...
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...
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...
Piroxicam USP
Test Specification Min Max ASSAY 97 103.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.30% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS...
Niacin Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.00% 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.02% SULFATES (SO[@4@]) 0.02% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED LEAD...
Potassium Gluconate Anhydrous USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 3.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED REDUCING SUBSTANCES 1.00% IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF...
Xylazine Hydrochloride USP
Test Specification Min Max ASSAY 98 102.00% MELTING RANGE 164� 168�C pH (1% IN WATER) 4 6 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% RESIDUE...
Chlorobutanol Anhydrous NF
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 100.50% REACTION (to LITMUS) NEUTRAL NEUTRAL WATER DETERMINATION 1.00% CHLORIDE 0.07% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION A TO PASS TEST...
Flunixin Meglumine USP
Test Specification Min Max ASSAY 98 102.00% pH (1 IN 20) 7 9 SPECIFIC ROTATION [a][@D@] -9� to -12� -9� to -12� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20%...
Naphazoline Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 1 % SOLUTION @ 25[dC 5 6.6 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES: TO...
Aspirin USP
Test Specification Min Max ASSAY (C[@9@]H[@8@]O[@4@]) 99.5 100.50% LOSS ON DRYING 0.50% READILY CARBONIZABLE SUBSTANCES NO MORE NO MORE RESIDUE ON IGNITION 0.05% SUBSTANCES INSOLUBLE IN SODIUM CARBONATE SOLUTION IS...
Dehydrocholic Acid USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE (MAX. 3 C RANGE) 231 242�C SPECIFIC ROTATION [a][@D@] +29.0 to +32.5� +29.0 to +32.5� MICROBIAL LIMITS TO PASS...
Acetylcysteine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] +21 to +27 +21 to +27 pH OF A 1 IN 100 SOLUTION 2 2.8 LOSS ON DRYING...
Hydrocortisone Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a]D25 +150� to +156� +150� to +156� PARTICLE SIZE (THROUGH 15 micron) 90% LOSS ON DRYING 1.00% RESIDUE ON...
Trichlormethiazide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SELENIUM (Se) 0.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED DIAZOTIZABLE SUBSTANCES 2.50% IDENTIFICATION...
Prednisolone Sodium Phosphate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 96 102.00% SPECIFIC ROTATION, [a][@D@]25 +95� to +102� +95� to +102� pH OF A 1 IN 100 SOLUTION 7.5 10.5 WATER DETERMINATION 6.50%...
Prednisolone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +112 to +119 +112 to +119 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% ELEMENTAL IMPURITIES: NICKEL...
Estradiol Plant Base Micronized USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% MELTING RANGE 173� 179�C SPECIFIC ROTATION [a][@D@]25 +76� to +83� +76� to +83� PARTICLE SIZE (THROUGH 20 micron) 92% WATER DETERMINATION...
Oxybutynin Chloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% CHLORIDE CONTENT (DRIED BASIS) 8 10% LOSS ON DRYING 3% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS...
Isoxsuprine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% pH OF A 1 IN 100 SOLUTION 4.5 6 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES: PALLADIUM (Pd)...
Sulindac USP
Test Specification Min Max ASSAY (C[@20@]H[@17@]FO[@3@]S; 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...
Potassium Chloride Crystal USP
Test Specification Min Max ASSAY 99 100.50% ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% BROMIDE 0.10% IODIDE 0.01% CALCIUM AND MAGNESIUM TO PASS TEST...
Ketoprofen Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 92.0� 97.0� SPECIFIC ROTATION, [a][@D@]25 +1� to -1� +1� to -1� LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS...
Mefenamic Acid BP
Test Specification Min Max ASSAY (C[@15@]H[@15@]NO[@2@]; DRIED BASIS) 99 101.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST COPPER (Cu) 10 ppm LOSS ON DRYING 0.50% SULPHATED ASH 0.10% ELEMENTAL...
Doxapram Hydrochloride Monohydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 3 4.50% pH 3.5 5 ORGANIC IMPURITIES TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 0.30% HEAVY...
Amantadine Hydrochloride USP
Test Specification Min Max ASSAY 98.5 101.50% CLARITY AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 20% SOLUTION 3 5.5 ORGANIC IMPURITIES TO PASS TEST...
Itraconazole Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% OPTICAL ROTATION, [a] 20D -0.10 to +0.10 -0.10 to +0.10 RESIDUE ON IGNITION 0.10% LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO...
Tinidazole 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 ORGANIC IMPURITIES . . TINIDAZOLE RELATED COMPOUND A 0.20%...
Flurbiprofen USP
Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% MELTING RANGE 114� - 117�C 114� - 117�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL...