Sodium Stearate Powder NF
Test Specification Min Max ASSAY (STEARIC ACID AND PALMITIC ACID) 90% ASSAY (STEARIC ACID) AS REPORTED AS REPORTED ACID VALUE 196 211 ACIDITY (AS STEARIC ACID) 0.28 1.20% LOSS ON...
Pyridoxine Hydrochloride FCC
Test Specification Min Max ASSAY (C[@8@]H[@11@]NO[@3@].HCl; DRIED BASIS) 98 100.50% CHLORIDE CONTENT (Cl; DRIED BASIS) 16.9 17.60% LEAD (Pb) 2 mg/kg LOSS ON DRYING 0.50% RESIDUE AFTER IGNITION 0.10% IDENTIFICATION...
Nortriptyline Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 101.50% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES: LEAD (Pb) AS...
Lemon Oil California Type Cold-pressed FCC
Test Specification Min Max ASSAY (ALDEHYDES AS CITRAL) 2.2 - 3.8 % 2.2 - 3.8 % ANGULAR ROTATION +57 to +65.6 +57 to +65.6 REFRACTIVE INDEX @ 20[dC 1.473 -...
Propranolol Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.50% MELTING RANGE 162 165�C SPECIFIC ROTATION [a][@D@](C=0.04;water) -1.0 to +1.0� -1.0 to +1.0� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...
Hydrochlorothiazide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.04% SELENIUM (Se) 30 ppm ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED...
Karaya Gum FCC
Test Specification Min Max ACTAL VISCOSITY OF A 1% SOLUTION AS REPORTED AS REPORTED ASH (ACID-INSOLUBLE) 1.00% INSOLUBLE MATTER 3.00% LEAD (Pb) 2 mg/kg LOSS ON DRYING 20.00% STARCH TO...
Terbutaline Sulfate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST ACIDITY (as ACETIC ACID) 0.30% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20%...
Doxepin Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% (Z)-ISOMER 13.6 18.10% (E)-ISOMER 81.4 88.20% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO...
Sorbitan Monostearate FCC
Test Specification Min Max ASSAY (POLYOLS) 27.0 - 34.0 % 27.0 - 34.0 % ASSAY (FATTY ACIDS) 68 - 76 % 68 - 76 % ACID VALUE 05-Oct 05-Oct HYDROXYL...
L-Serine FCC
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION, [a]D20 (DRIED BASIS) +13.6� to +160. +13.6� to +160. LEAD (Pb) 5 mg/kg...
Xylometazoline Hydrochloride USP
Test Specification Min Max ASSAY (C[@16@]H[@24@]N[@2@].HCl; DRIED BASIS) 99 101.00% pH (in to 20 Solution) 5 6.6 LOSS ON DRYING 0.50% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST RESIDUE...
Haloperidol USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...
Epinephrine USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 100.50% SPECIFIC ROTATION [a][@D@] -50.0� to -54.0 -50.0� to -54.0 LOSS ON DRYING 2.00% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ADRENALONE TO PASS...
Homosalate USP
Test Specification Min Max ASSAY 90 110% SPECIFIC GRAVITY 1.049 1.053 REFRACTIVE INDEX @ 20�C 1.516 1.519 ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST...
Mercaptopurine Monohydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST PHOSPHORUS 100 ppm RESIDUE ON IGNITION 0.10% WATER DETERMINATION 12.00% IDENTIFICATION TO PASS...
Potassium Sodium Tartrate Tetrahydrate Granular USP
Test Specification Min Max ASSAY (KNaC[@4@]H[@4@]O[@6@]) 99 102.00% ALKALINITY TO PASS TEST WATER DETERMINATION 21 27.00% AMMONIA (NH[@3@]) TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS...
Allopurinol USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% HYDRAZINE 10 ppm ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS...
Pyrilamine Maleate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% MELTING RANGE 99� 103�C LOSS ON DRYING 0.50% RESIDUE AFTER IGNITION 0.10% RELATED COMPOUNDS AS REPORTED INDIVIDUAL 0.30% TOTAL 1.00% ELEMENTAL...
L-Alanine FCC
Test Specification Min Max ASSAY (C[@3@]H[@7@]NO[@2@]; DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] +13.5� to+15.5 +13.5� to+15.5 LOSS ON DRYING 0.30% LEAD (Pb) 5 mg/kg RESIDUE ON IGNITION 0.20% IDENTIFICATION...
Potassium Bicarbonate Granular FCC
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.50% CARBONATE (CO[@3@]) TO PASS TEST LEAD (Pb) 2 mg/kg LOSS ON DRYING 0.25% IDENTIFICATION A TO PASS TEST IDENTIFICATION B TO...
Hydroxyzine Pamoate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% WATER DETERMINATION 5.00% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION...
Mesalamine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% CLARITY OF SOLUTION TO PASS TEST TO PASS TEST pH (1 in 40 suspension) 3.5 4.5 LOSS ON DRYING 0.50% RESIDUE...
Ichthammol USP
Test Specification Min Max AMMONIA (NH[@3@]) 2.50% TOTAL SULFUR (S) 10.00% LOSS ON DRYING 50.00% RESIDUE ON IGNITION 0.50% AMMONIUM SULFATE 8.00% ELEMENTAL IMPURITIES: ARSENIC (As) AS REPORTED AS REPORTED...
Magnesium Aluminum Silicate Type IA NF
Test Specification Min Max VISCOSITY @ 33 +/- 3 �C 225 600 mPa.s pH of a 5 in 100 SUSPENSION 9 10 RATIO OF CONTENT ALUMINUM / MAGNESIUM 0.5 1.2...
Tamoxifen Citrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% E-ISOMER 0.30% IRON (Fe) 0.01% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED IMPURITIES...
Sodium Chloride Non-Iodized Granular FCC
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% ARSENIC (As) 1 mg/kg CALCIUM AND MAGNESIUM 0.35% HEAVY METALS (as Pb) 2 mg/kg IRON (Fe) 0.00% LOSS ON DRYING 0.50%...
Fluoxetine Hydrochloride USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST...
Sucralfate Fine Powder USP
Test Specification Min Max ASSAY 30 38.00% ALUMINUM CONTENT 15.5 18.50% CLARITY AND COLOR OF SOLUTION CLEAR AND CLEAR AND ACID NEUTRALIZING CAPACITY 12 mEq CHLORIDE (Cl) 0.50% ARSENIC (As)...
Papaverine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 100.50% pH OF A 1 IN 50 SOLUTION 3 4.5 COMPLETENESS OF SOLUTION TO PASS TEST LOSS ON DRYING 0.50% RESIDUE AFTER...
Podophyllum Resin BP 80
Test Specification Min Max SOLUBILITY TO PASS TEST TO PASS TEST MATTER-INSOLUBLE IN 5M AMMONIA RESIN OF P. PELTATUM 50 mg/0.50 RESIN OF P. HEXANDRUM 0.18-0.30 g/0.50 0.18-0.30 g/0.50 ETHANOL(96%)-INSOLUBLE...
Methoxsalen USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% MELTING RANGE 143� - 148�C 143� - 148�C WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED CHROMATOGRAPHIC IMPURITIES...
Methylcellulose 4000 cP FCC
Test Specification Min Max ASSAY [METHOXYL GROUPS (-OCH[@3@]); DRIED BASIS] 27.5 31.50% VISCOSITY OF A 2g IN 100 ml SOLN 3000 - 5600 cP 3000 - 5600 cP LEAD (Pb)...
Clove Oil FCC
Test Specification Min Max ASSAY (PHENOLS) 85.00% ANGULAR ROTATION -1.5� to 0� -1.5� to 0� PHENOLS TO PASS TEST TO PASS TEST REFRACTIVE INDEX @ 20[dC 1.527 1.535 SOLUBILITY IN...
Eucalyptus Oil FCC
Test Specification Min Max ASSAY (as EUCALYPTOL: C[@10@]H[@18@]O) 70.00% SOLUBILITY IN 70% ALCOHOL (v/v) TO PASS TEST TO PASS TEST SPECIFIC GRAVITY @ 25[dC 0.905- 0.925 0.905- 0.925 REFRACTIVE INDEX...
Ranitidine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.5 102.00% pH OF A 1 IN 100 SOLUTION 4.5 6 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.75% RESIDUE ON IGNITION...