Ascorbyl Palmitate NF
Test Specification Min Max ASSAY (DRIED BASIS) 95.0 - 100.5 % 95.0 - 100.5 % SPECIFIC ROTATION [a]D25 +21� to +24� +21� to +24� LOSS ON DRYING 2.00% RESIDUE ON...
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...
L-Threonine Crystal FCC
Test Specification Min Max ASSAY (C[@4@]H[@9@]NO[@3@]; DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION, [a] 20D -26.5 to-29.0 -26.5 to-29.0 LEAD 5 mg/kg LOSS ON DRYING...
Coriander Oil FCC
Test Specification Min Max ANGULAR ROTATION +8 to +15 +8 to +15 REFRACTIVE INDEX 1.462- 1.472 1.462- 1.472 SOLUBILITY IN ALCOHOL TO PASS TEST TO PASS TEST SPECIFIC GRAVITY @...
Origanum Oil Spanish Type FCC
Test Specification Min Max ASSAY 60.0 - 75.0 % 60.0 - 75.0 % ANGULAR ROTATION -2 to +3 -2 to +3 REFRACTIVE INDEX @ 20[dC 1.506- 1.512 1.506- 1.512 SOLUBILITY...
Copaiba Oil FCC
Test Specification Min Max ANGULAR ROTATION -7 to -33 -7 to -33 REFRACTIVE INDEX @ 20[dC 1.493 1.5 SPECIFIC GRAVITY @ 25[dC 0.88 0.907 GURJUN OIL NONE DETECTED NONE DETECTED...
L-Isoleucine FCC
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION +38.6 to+41.5 +38.6 to+41.5 LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.30% RESIDUE...
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...
Lemongrass Oil East-Indian Type FCC
Test Specification Min Max ASSAY (ALDEHYDES AS CITRAL) 75.00% ANGULAR ROTATION -10� to 0� -10� to 0� REFRACTIVE INDEX @ 25[dC 1.483 - 1.489 1.483 - 1.489 SOLUBILITY IN ALCOHOL...
Proparacaine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.0-103.0 % 97.0-103.0 % MELTING RANGE (MAX. 2[dC) 178 - 185 C 178 - 185 C LOSS ON DRYING 0.50% RESIDUE ON IGNITION...
Magnesium Gluconate Dihydrate FCC
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.0-102.0 % 98.0-102.0 % WATER 3.0- 12.0 % 3.0- 12.0 % CHLORIDE (Cl) 0.05% LEAD (Pb) 2 mg/kg REDUCING SUBSTANCES 1.00% SULFATE 0.05%...
Grapefruit Oil Coldpressed FCC
Test Specification Min Max ANGULAR ROTATION +91 to +96 +91 to +96 REFRACTIVE INDEX @ 20[dC 1.475 - 1.478 1.475 - 1.478 RESIDUE ON EVAPORATION 5.0 - 10.0 % 5.0...
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...
Oxytocin USP
Test Specification Min Max ASSAY 400 USP oxytocin 400 USP oxytocin ACETIC ACID 6 10% MICROBIAL LIMITS 200 cfu/g ORDINARY IMPURITIES 5% ELEMENTAL IMPURITIES: PALLADIUM (Pd) AS REPORTED AS REPORTED...
Ergocalciferol USP
Test Specification Min Max ASSAY (C[@28@]H[@44@]O) 97 103.00% MELTING RANGE 115 119�C SPECIFIC ROTATION [a][@D@] +103� to +106� +103� to +106� REDUCING SUBSTANCES TO PASS TEST TO PASS TEST ELEMENTAL...
Pantoprazole Sodium USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 5 8.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TEST 2: PANTOPRAZOLE RELATED COMPOUND C 0.10% PANTOPRAZOLE RELATED...
Folic Acid Powder FCC
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95.0 - 102.0 % 95.0 - 102.0 % LEAD (Pb) 2 mg/kg RESIDUE ON IGNITION 0.30% WATER 8.50% IDENTIFICATION TO PASS TEST EXPIRATION...
Orange Oil Florida Type Coldpressed FCC
Test Specification Min Max ASSAY (ALDEHYDES AS DECYL ALDEHYDE) 1.2 2.50% ANGULAR ROTATION +94� to +99� +94� to +99� REFRACTIVE INDEX @ 20[dC 1.472 1.474 SPECIFIC GRAVITY @ 25[dC 0.842...
Sodium Carbonate Monohydrate FCC
TestSpecificationMinMaxASSAY (Na[@2@]CO[@3@]; DRY BASIS)99.5100.50%LOSS ON DRYING1215.00%LEAD (Pb)4 mg/kgIDENTIFICATIONTO PASS TESTEXPIRATION DATE
Mecobalamin JP
Test Specification Min Max ASSAY (ANHYDROUS) 98 101.00% CLARITY AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST WATER 12% RELATED SUBSTANCES TO PASS TEST TO PASS TEST IDENTIFICATION...
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...
Dibucaine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 100.5% 97.0 - 100.5% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.10% ELEMENTAL...
Mafenide Acetate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% MELTING RANGE (WITHIN 4�C) 162� 171�C pH OF A 10% SOLUTION 6.4 6.8 WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.20% SELENIUM...
Betahistine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% pH OF A 1 IN 10 SOLUTION 2 3 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...
Topiramate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]20 -28.6 to -35.0 -28.6 to -35.0 WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.20% SULFAMATE 0.10% SULFATE 0.10% ELEMENTAL...
Dibasic Sodium Phosphate Dodecahydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% LOSS ON DRYING 55 64.00% INSOLUBLE SUBSTANCES 0.40% CHLORIDE (Cl) 0.06% SULFATE 0.20% ARSENIC (As) 16 ppm ELEMENTAL IMPURITIES AS REPORTED...
L-Lysine Monohydrochloride FCC
Test Specification Min Max ASSAY (C[@6@]H[@14@]N[@2@]O[@2@].HCl; DRIED BASIS) 98.5 101.50% OPTICAL ROTATION, @ 20D +20.3 to +21.5 +20.3 to +21.5 LEAD 5 mg/kg LOSS ON DRYING 1.00% RESIDUE ON IGNITION...
Glyburide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0-102.0 % 98.0-102.0 % CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS...
Ethyl Maltol FCC
TestSpecificationMinMaxASSAY (C[@7@]H[@8@]O[@3@]); ANHYDROUS BASIS99.00%RESIDUE ON IGNITION0.20%WATER0.50%IDENTIFICATIONTO PASS TESTTO PASS TESTCERTIFIED KOSHERCERTIFIED HALALEXPIRATION DATE
Sodium Potassium Tartrate Tetrahydrate Powder FCC
Test Specification Min Max ASSAY 99.0-102.0 % 99.0-102.0 % ALKALINITY TO PASS TEST TO PASS TEST WATER 21.0- 26.0 % 21.0- 26.0 % LEAD (Pb) 2 mg/kg IDENTIFICATION TO PASS...
Terbinafine Hydrochloride EP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% RELATED SUBSTANCES: . . IMPURITY B 0.15% IMPURITY E 0.05% UNSPECIFIED IMPURITIES 0.10 % each TOTAL IMPURITIES 0.30% LOSS ON DRYING...