Methylparaben FCC
Test Specification Min Max ASSAY (C[@8@]H[@8@]O[@3@]; DRIED BASIS) 99 100.50% MELTING RANGE 125� 128�C ACIDITY TO PASS TEST LEAD (Pb) 2 mg/kg LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.05%...
Leucovorin Calcium USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95 105.00% WATER DETERMINATION 17.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS...
Alanine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION +13.7 to+15.1 +13.7 to+15.1 pH (1 in 20 solution) 5.5 7 LOSS ON DRYING 0.20% RESIDUE ON IGNITION 0.15%...
DL-Alanine FCC
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 -101.5 % 98.5 -101.5 % LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.30% RESIDUE ON IGNITION 0.20% IDENTIFICATION TO PASS TEST RETEST...
Amlodipine Besylate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% OPTICAL ROTATION, [a] 20D -0.10 to +0.10� -0.10 to +0.10� WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED...
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...
Nifedipine Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0-102.0 % 98.0-102.0 % LOSS ON DRYING 0.50% RESIDUE ON IGNITION @600[d 0.10% ELEMENTAL IMPURITIES AS REPORTED PERCHLORIC ACID TITRATION TO PASS TEST...
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...
Phytochol cGMP Manufactured
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING POINT 147 150�C ACIDITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.30% HEAVY METALS 10 ppm RESIDUE ON...
Potassium Alum Dodecahydrate Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% LOSS ON DRYING 43 46.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IRON (Fe) TO PASS TEST TO PASS TEST IDENTIFICATION TO...
Calcium Silicate NF
Test Specification Min Max CALCIUM OXIDE (CaO) 20 35% SILICON DIOXIDE (SiO[@2@]) 50 65% SUM OF CALCIUM OXIDE, SILICON DIOXIDE AND LOS ON IGNITION 90.00% pH (1 in 20 suspension)...
L-Tyrosine FCC
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION -10.0 to-11.0 -10.0 to-11.0 LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.30% RESIDUE...
Undecylenic Acid USP
Test Specification Min Max ASSAY 97 100.50% SPECIFIC GRAVITY 0.91 0.913 CONGEALING RANGE 21�C REFRACTIVE INDEX 1.447 1.448 IODINE VALUE 131 138 RESIDUE ON IGNITION 0.15% WATER-SOLUBLE ACIDS 1.0 ml...
Potassium Nitrate Crystal USP
Test Specification Min Max ASSAY 99 100.50% CHLORIDE (Cl) 0.03% SULFATE 0.10% ARSENIC (As) 3 ppm LEAD (Pb) 10 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IRON (Fe) 10 ppm...
Niacinamide USP
Test Specification Min Max ASSAY (C[@6@]H[@6@]N[@2@]O) 98.5 101.50% MELTING RANGE 128 131�C LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES AS REPORTED READILY CARBONIZABLE SUBSTANCES TO PASS TEST RESIDUE ON IGNITION 0.10%...
Sodium Sulfite NF FCC EP BP
Test Specification Min Max ASSAY 95 100.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED LEAD (Pb) 2 mg/kg SELENIUM (Se) 10 ppm THIOSULFATE TO PASS TEST TO PASS TEST APPEARANCE OF...
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...
Pentoxifylline BP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ACIDITY TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST...
Tannic Acid USP
Test Specification Min Max LOSS ON DRYING 12.00% RESIDUE AFTER IGNITION 1.00% ARSENIC (As) 3 ppm GUM OR DEXTRIN TO PASS TEST TO PASS TEST RESINOUS SUBSTANCES TO PASS TEST...
Sorbic Acid Powder FCC
Test Specification Min Max ASSAY (C[@6@]H[@8@]O[@2@]; ANHYDROUS BASIS) 99 101.00% MELTING RANGE 132� 135�C LEAD (Pb) 2 mg/kg RESIDUE ON IGNITION 0.20% WATER 0.50% IDENTIFICATION TO PASS TEST EXPIRATION DATE...
Ammonium Alum Dodecahydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% LOSS ON DRYING 45 48.00% ALKALIES AND ALKALINE EARTHS 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IRON (Fe) TO PASS TEST...
Manganese Citrate Decahydrate FCC
Test Specification Min Max ASSAY (Mn[@3@](C[@6@]H[@5@]O[@7@])[@2@]; DRIED BASIS) 96.5 - 104.8 % 96.5 - 104.8 % LOSS ON DRYING 23.0 - 26.0 % 23.0 - 26.0 % ARSENIC 3 mg/kg...
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...
Ferrous Gluconate FCC
Test Specification Min Max ASSAY (C[@12@]H[@22@]FeO[@14@]; DRIED BASIS) 97 102.00% LOSS ON DRYING 6.5 10.00% CHLORIDE (Cl) 0.07% FERRIC IRON (Fe [d) 2.00% LEAD (Pb) 2 mg/kg MERCURY 3 mg/kg...
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...
Levamisole Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.0% 98.5 - 101.0% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST COLOR OF SOLUTION TO PASS TEST TO PASS...
Maltitol Solution NF
Test Specification Min Max ASSAY (C[@12@]H[@24@]O[@11@]; ANHYDROUS BASIS) 50.00% pH OF A 14 % SOLUTION 5 7.5 D-SORBITOL (C[@6@]H[@14@]O[@6@]; ANHYDROUS BASIS) 8.00% WATER DETERMINATION 31.50% RESIDUE ON IGNITION 0.10% NICKEL...
Lactic Acid 85 Percent FCC
Test Specification Min Max ASSAY (C[@3@]H[@6@]O[@3@]) 81 - 89% 81 - 89% CHLORIDE (Cl) 0.10% CITRIC, OXALIC, PHOSPHORIC AND TARTARIC ACID TO PASS TEST TO PASS TEST CYANIDE 5 mg/kg...
Cumin Oil FCC
Test Specification Min Max ASSAY (ALDEHYDES as C[@10@]H[@12@]O) 45.0 - 54.0 % 45.0 - 54.0 % ANGULAR ROTATION +3 to +8 +3 to +8 REFRACTIVE INDEX @ 20[dC 1.500- 1.506...
Polysorbate 40 NF
Test Specification Min Max HYDROXYL VALUE 89 105 SAPONIFICATION VALUE 41 52 COMPOSITION OF FATTY ACIDS TO PASS TEST TO PASS TEST WATER DETERMINATION 3.00% PEROXIDE VALUE 10 ACID VALUE...
Hydroxypropyl Methylcellulose 4000 cps FCC
Test Specification Min Max ASSAY (METHOXY GROUPS) 19 30.00% ASSAY (HYDROXYPROPOXY GROUPS) 3 12.00% VISCOSITY OF A 2% AQUEOUS SOLUTION @ 20D [dC 3000 5600 cps LEAD (Pb) 3 mg/kg...
Ferrous Gluconate USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% LOSS ON DRYING 6.5 10.00% CHLORIDE (Cl) 0.07% SULFATE 0.10% OXALIC ACID TO PASS TEST ARSENIC (As) 3 ppm FERRIC IRON...
Citric Acid Anhydrous Granular FCC
Test Specification Min Max ASSAY (C[@6@]H[@8@]O[@7@] ;ANHYD.,BASIS) 99.5 100.50% LEAD 0.5 mg/kg OXALATE TO PASS TEST READILY CARBONIZABLE SUBSTANCES TO PASS TEST RESIDUE ON IGNITION 0.05% TRIDODECYLAMINE 0.1 mg/ WATER...
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...
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