Panthenol USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 102.00% MELTING RANGE 64.5 68.5�C SPECIFIC ROTATION [a][@D@] -0.05 to +0.05� -0.05 to +0.05� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...
Ciclopirox Olamine USP
Test Specification Min Max ASSAY 97.5 101.50% pH OF A 1% SOLUTION 8 9 MONOETHANOLAMINE 223 230 mg/g RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS...
Imidurea NF
Test Specification Min Max ASSAY (AS NITROGEN; DRIED BASIS) 26 28.00% COLOR AND CLARITY OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 1% SOLUTION 6 7.5 LOSS...
Dextromethorphan Hydrobromide Monohydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 1 % SOLUTION @ 25[dC 5.2 6.5 WATER DETERMINATION 3.5 5.50% RESIDUE ON IGNITION 0.10% N,N-DIMETHYLANILINE 0.00% PHENOLIC...
Metoprolol Tartrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]20 +6.5� to+10.5� +6.5� to+10.5� pH OF A 1 IN 10 SOLUTION 6 7 LOSS ON DRYING 0.50% RESIDUE...
Methylcellulose 400 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 300 560 cP LEAD (Pb) 3 mg/kg LOSS ON DRYING...
Maltol FCC
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99.00% MELTING RANGE 160 - 164 C 160 - 164 C RESIDUE ON IGNITION 0.20% WATER 0.50% IDENTIFICATION TO PASS TEST TO PASS...
Acetazolamide USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% CHLORIDE 0.01% SULFATE 0.04% SELENIUM 30 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED SILVER...
L-Methionine FCC
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION +21.0 to+25.0 +21.0 to+25.0 LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.50% RESIDUE...
Minoxidil Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 0.50% ORGANIC IMPURITIES 1.50% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION SPECTRUM MATCHES SPECTRUM...
Lidocaine USP
Test Specification Min Max ASSAY 97.5 102.50% CHLORIDE (Cl) 0.00% RESIDUE ON IGNITION 0.10% SULFATE 0.10% ORGANIC IMPURITIES: LIDOCAINE RELATED COMPOUND H 0.10% 2,6- DIMETHYLANILINE 0.01% ANY UNSPECIFIED IMPURITY 0.10%...
Calcium Levulinate USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.5 100.50% MELTING RANGE 119� 125�C pH OF A 10% SOLUTION 7 8.5 LOSS ON DRYING 10.5 12.00% CHLORIDE 0.07% SULFATE 0.05% ARSENIC...
Hydrogenated Castor Oil NF
Test Specification Min Max HYDROXYL VALUE 154 162 SAPONIFICATION VALUE 176 182 ALKALINE IMPURITY TO PASS TEST TO PASS TEST TRIGLYCERIDE COMPOSITION TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...
Ammonium Bicarbonate FCC
Test Specification Min Max ASSAY (NH[@4@]HCO[@3@]) 99.0 - 100.5% 99.0 - 100.5% CHLORIDE (Cl) 0.00% LEAD (Pb) 3 mg/kg NONVOLATILE RESIDUE 0.55% SULFUR COMPOUNDS 0.01% IDENTIFICATION TO PASS TEST RETEST...
Aluminum Sulfate Crystal FCC
Test Specification Min Max ASSAY [Al[@2@](SO[@4@])[@3@]] 99.5-114.0 % 99.5-114.0 % ALKALIES AND ALKALINE EARTHS TO PASS TEST(lim TO PASS TEST(lim AMMONIUM SALTS TO PASS TEST TO PASS TEST FLUORIDE 0.00%...
Sodium Phosphate Monobasic Monohydrate Granular FCC
Test Specification Min Max ASSAY (DRIED BASIS) 98 103.00% LOSS ON DRYING 10 15.00% ARSENIC (As) 3 mg/kg FLUORIDE 0.01% INSOLUBLE SUBSTANCES 0.20% LEAD (Pb) 4 mg/kg IDENTIFICATION TO PASS...
Cupric Sulfate Pentahydrate Granular USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 100.50% LOSS ON DRYING 33 36.50% SODIUM (Na) 0.02% POTASSIUM (K) 0.01% CALCIUM (Ca) 0.01% IRON (Fe) 0.00% NICKEL (Ni) 0.01% ELEMENTAL...
All-rac-a-Tocopheryl Acetate FCC
Test Specification Min Max ASSAY (C[@31@]H[@52@]O[@3@]) 96 102.00% ACIDITY TO PASS TEST LEAD (Pb) 2 mg/kg IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE
L-Valine Crystal FCC
Test Specification Min Max ASSAY (C[@5@]H[@11@]NO[@2@]; DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION, [a] 20D +26.7 to +29.0 +26.7 to +29.0 LEAD 5 mg/kg LOSS...
Bismuth Subgallate USP
Test Specification Min Max ASSAY (Bi[@2@]O[@3@]; DRIED BASIS) 52 57.00% NITRATE TO PASS TEST ARSENIC 7.5 ppm COPPER TO PASS TEST LEAD TO PASS TEST SILVER TO PASS TEST ALKALIES...
Strong Ammonia Solution NF
Test Specification Min Max ASSAY (NH[@3@], by wt.) 27 31.00% NONVOLATILE RESIDUE 0.05% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED READILY OXIDIZABLE SUBSTANCES TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION...
Potassium Phosphate Tribasic FCC
Test Specification Min Max ASSAY (IGNITED) 97.00% 97.00% ARSENIC (As) 3 mg/kg FLUORIDE 10 mg/kg INSOLUBLE SUBSTANCES 0.20% LEAD (Pb) 2 mg/kg LOSS ON IGNITION 5.00% IDENTIFICATION TO PASS TEST...
Ammonium Phosphate Granular NF
Test Specification Min Max ASSAY 96 102.00% pH OF A 1 IN 100 SOLUTION 7.6 8.2 CHLORIDE (Cl) 0.03% SULFATES (SO[@4@]) 0.15% ARSENIC (As) 3 ppm ELEMENTAL IMPURITIES AS REPORTED...
Calcium Phosphate Tribasic Powder FCC
Test Specification Min Max ASSAY (Ca) 34.0 - 40.0 % 34.0 - 40.0 % FLUORIDE 0.01% ARSENIC (As) 3 mg/kg LEAD (Pb) 2 mg/kg LOSS ON IGNITION 10.00% IDENTIFICATION TO...
Ammonium Chloride Granular FCC
Test Specification Min Max ASSAY (DRIED BASIS) 99.00% LEAD (Pb) 4 mg/kg LOSS ON DRYING 0.50% IDENTIFICATION TO PASS TEST TO PASS TEST RETEST DATE
Calcium Citrate Tetrahydrate Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.5 100.50% LOSS ON DRYING 10 13.30% ARSENIC (As) 3 ug/g FLUORIDE 0.00% ACID-INSOLUBLE SUBSTANCES 0.20% LEAD (Pb) 0.00% ELEMENTAL IMPURITIES AS REPORTED...
L-Glutamic Acid FCC
Test Specification Min Max ASSAY (C[@5@]H[@9@]NO[@4@]; DRIED BASIS) 98.5 101.50% OPTICAL ROTATION, @ 20D +31.5� to +32.5 +31.5� to +32.5 LEAD 5 mg/kg LOSS ON DRYING 0.10% RESIDUE ON IGNITION...
Sorbitan Monostearate NF
Test Specification Min Max ASSAY (FATTY ACIDS) 68 76.00% ASSAY (POLYOLS; w/w) 27 34.00% HYDROXYL VALUE 235 260 SAPONIFICATION VALUE 147 157 ACID VALUE 10 WATER DETERMINATION 1.50% RESIDUE ON...
Dexpanthenol USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% REFRACTIVE INDEX @ 20[dC 1.495 1.502 SPECIFIC ROTATION [a][@D@] +29.0� to+31.5 +29.0� to+31.5 AMINOPROPANOL 1.00% RESIDUE ON IGNITION 0.10% WATER DETERMINATION...
Diethyl Phthalate NF
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% SPECIFIC GRAVITY @ 20�C 1.118 1.122 REFRACTIVE INDEX @ 20�C 1.5 1.505 WATER DETERMINATION 0.20% ACIDITY TO PASS TEST RESIDUE ON...
Ferrous Fumarate USP
Test Specification Min Max ASSAY (C[@4@]H[@2@]FeO[@4@]) 97 101.00% LOSS ON DRYING 1.50% SULFATES (SO[@4@]) 0.20% ARSENIC (As) 3 ppm FERRIC IRON (Fe [d) 2.00% LEAD (Pb) 10 ppm MERCURY 3...
Propylparaben FCC
Test Specification Min Max ASSAY (C[@10@]H[@12@]O[@3@]); DRIED BASIS) 99 100.50% ACIDITY TO PASS TEST MELTING RANGE 95?? 98?? LEAD 2 mg/kg LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.05% IDENTIFICATION...
Heavy Magnesium Oxide Heavy Powder FCC
Test Specification Min Max ASSAY (AFTER IGNITION) 96 100.50% ACID-INSOLUBLE SUBSTANCES 0.10% ALKALIES (FREE) AND SOLUBLE SALTS TO PASS TEST ARSENIC 3 mg/kg CALCIUM OXIDE (CaO) 1.50% LEAD 4 mg/kg...
Light Magnesium Oxide Light Powder FCC
Test Specification Min Max ASSAY (AFTER IGNITION) 96 100.50% ACID-INSOLUBLE SUBSTANCES 0.10% ALKALIES (FREE) AND SOLUBLE SALTS TO PASS TEST ARSENIC (As) 3 mg/kg CALCIUM OXIDE (CaO) 1.50% LEAD (Pb)...
Mineral Oil White Heavy FCC
Test Specification Min Max CARBON NUMBER AT 5% DISTILLATION POINT 28 SPECIFIC GRAVITY 0.845- 0.905 0.845- 0.905 UV ABSORBANCE (POLYNUCLEAR HYDROCARBONS) TO PASS TEST TO PASS TEST VISCOSITY @ 100[d...
Mineral Oil Medium and Low Viscosity FCC
Test Specification Min Max CARBON NUMBER AT 5% DISTILLATION POINT 17 25 SPECIFIC GRAVITY @ 25�C 0.829 0.859 ULTRAVIOLET ABSORBANCE (POLYNUCLEAR HYDROCABONS) TO PASS TEST TO PASS TEST VISCOSITY @...
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