Anhydrous Lactose NF
Test Specification Min Max CLARITY AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST SPECIFIC ROTATION [a][@D@] +54.4 to+55.9 +54.4 to+55.9 ACIDITY or ALKALINITY TO PASS TEST TO PASS...
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...
Petrolatum Yellow USP
Test Specification Min Max SPECIFIC GRAVITY @60 C 0.815 0.88 MELTING RANGE 38� 60�C CONSISTENCY TO PASS TEST STABILIZER (BUTYLHYDROXYTOLUENE) 20 ppm COLOR TO PASS TEST ACIDITY TO PASS TEST...
FD and C Blue No. 1
Test Specification Min Max FDA LOT NUMBER TOTAL COLOR 85% ARSENIC (As) 3 ppm CHROMIUM (as Cr) 50 ppm N-ETHYL,N-(M-SULFOBENZYL)SULFANILIC ACID 0.30% LEAD (Pb) 10 ppm LEUCO BASE 5% SUM...
D and C Red No. 4
Test Specification Min Max CERTIFICATION LOT NUMBER: ASSAY 87% SUM OF VOLATILE MATER(@135C),[nCl &SO[@4@] 13.00% WATER-INSOLUBLE MATTER 0.20% AMINODIMETHYLBENZENESULFONIC ACID 0.20% HYDROXYNAPHTHALENESULFONIC ACID 0.20% SUBSIDIARY COLORS 2% LEAD (Pb) 20...
Polysorbate 20 NF
Test Specification Min Max SAPONIFICATION VALUE 40 50 HYDROXYL VALUE 96 108 WATER DETERMINATION 3.00% PEROXIDE VALUE 10 ACID VALUE 2 RESIDUE ON IGNITION 0.25% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS...
Squalane NF
Test Specification Min Max ASSAY 97 102.00% SPECIFIC GRAVITY @ 20[dC 0.807 0.81 REFRACTIVE INDEX @ 20[dC 1.451 1.4525 ACID VALUE 0.2 IODINE VALUE 4 SAPONIFICATION VALUE 2 RESIDUE ON...
FD and C Red No. 3
TestSpecificationMinMaxFDA LOT NUMBERDYE CONTENTIDENTIFICATIONTO PASS TESTTO PASS TESTEXPIRATION DATE
Aluminum Monostearate NF
Test Specification Min Max ASSAY (Al[@2@]O[@3@]; DRIED BASIS) 14.7 16.70% STEARIC AND PALMITIC ACID: STEARIC ACID 40.00% SUM OF STEARIC AND PALMITIC ACID 90.00% LOSS ON DRYING 3.00% ACIDITY AND...
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...
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...
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)...
Docusate Sodium USP
Test Specification Min Max ASSAY (ANHYDROUS) 99 100.50% CLARITY OF SOLUTION TO PASS TEST RESIDUE ON IGNITION 15.5 16.50% WATER DETERMINATION 2.00% ELEMENTAL IMPURITIES AS REPORTED BIS(2-ETHYLHEXYL) MALEATE 0.40% IDENTIFICATION...
Hypromellose Substitution Type 2208 100000 mPa.s USP
Test Specification Min Max VISCOSITY OF A 2% AQUEOUS SOLUTION @ 20D [dC 75000 - 140000 m 75000 - 140000 m ASSAY (METHOXY GROUPS) 19.4 24.00% ASSAY (HYDROXYPROPOXY GROUPS) 4...
Hypromellose Substitution Type 2208 100000 mPa.s USP
Test Specification Min Max VISCOSITY OF A 2% AQUEOUS SOLUTION @ 20D [dC 75,000 - 140,000 75,000 - 140,000 ASSAY (METHOXY GROUPS) 19 24.00% ASSAY (HYDROXYPROPOXY GROUPS) 4 12.00% pH...
Sodium L-Lactate Solution 60 Percent USP
Test Specification Min Max ASSAY (C[@3@]H[@5@]NaO[@3@]) 58.8 61.20% pH OF SOLUTION @ 25[dC 5 9 CHLORIDE (Cl) 0.05% SULFATES (SO[@4@]) TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED SUGARS...
Tribasic Calcium Phosphate Powder NF
Test Specification Min Max ASSAY (Ca) 34 40.00% LOSS ON IGNITION 8.00% WATER-SOLUBLE SUBSTANCES 0.50% ACID-INSOLUBLE SUBSTANCES 0.20% CARBONATE (CO[@3@]) TO PASS TEST CHLORIDE (Cl) 0.14% FLUORIDE 75 ppm NITRATE...
Calcium Carbonate Heavy Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% LOSS ON DRYING 2.00% ACID-INSOLUBLE SUBSTANCES 0.20% FLUORIDE 0.01% ARSENIC (As) 3 ppm BARIUM TO PASS TEST LEAD (Pb) 3 ppm...
Sorbitol Solution 70 Percent USP
Test Specification Min Max D-SORBITOL (C[@6@]H[@14@]O[@6@]; w/w) 64.00% 64.00% pH (14% Solution) 5 7.5 WATER DETERMINATION 28.5 31.50% NICKEL (Ni) 1 ppm RESIDUE ON IGNITION 0.10% REDUCING SUGARS TO PASS...
Corn Oil NF
Test Specification Min Max FATTY ACID COMPOSITION TO PASS TEST TO PASS TEST ACID VALUE 0.2 PEROXIDE VALUE 10 WATER DETERMINATION 0.10% ALKALINE IMPURITIES TO PASS TEST TO PASS TEST...
Povidone K-90 USP
Test Specification Min Max K VALUE 81 97.2 pH OF A 5% SOLUTION 4 7 NITROGEN CONTENT 11.5 12.80% ALDEHYDES 0.05% FORMIC ACID 0.50% HYDRAZINE 1 ppm LEAD 10 ppm...
Povidone K-30 USP
Test Specification Min Max K VALUE 27 32.4 pH OF A 5% SOLUTION 3 5 NITROGEN CONTENT 11.5 12.80% ALDEHYDE 0.05% FORMIC ACID 0.50% HYDRAZINE 1 ppm LEAD (Pb) 10...
Mineral Oil Heavy USP
Test Specification Min Max SPECIFIC GRAVITY @ 25[dC 0.845 0.905 VISCOSITY @40.0 C 34.5 150.0mm�/ ACIDITY TO PASS TEST TO PASS TEST READILY CARBONIZABLE SUBSTANCES TO PASS TEST TO PASS...
Kaolin Powder USP
Test Specification Min Max LOSS ON IGNITION 15.00% LEAD 10 ppm IRON TO PASS TEST TO PASS TEST ACID-SOLUBLE SUBSTANCES 2.00% CARBONATE TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...
Boric Acid Crystal NF
Test Specification Min Max ASSAY (DRIED BASIS) 99.5 100.50% SOLUBILITY IN ALCOHOL TO PASS TEST COMPLETENESS OF SOLUTION TO PASS TEST LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES: ARSENIC (As) AS...
Alginic Acid NF
Test Specification Min Max ACID VALUE (DRIED BASIS) 230 pH 1.5 3.5 MICROBIAL LIMITS TO PASS TEST TO PASS TEST LOSS ON DRYING 15.00% TOTAL ASH 4.00% ARSENIC (As) 3...
Ethyl Acetate NF
Test Specification Min Max ASSAY (CH[@3@]COOC[@2@]H[@5@]) 98 102.00% SPECIFIC GRAVITY @ 25[dC 0.894 0.898 ACIDITY TO PASS TEST CHROMATOGRAPHIC PURITY TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED NONVOLATILE...
Polyethylene Glycol 300 NF
Test Specification Min Max AVERAGE MOLECULAR WEIGHT 285 315 COMPLETENESS AND COLOR OF SOLUTION TO PASS TEST VISCOSITY @ 98.9 � 0.3�C (210�F) 5.4 6.4 cSt pH OF A 5%...
Phenol Fused Crystal USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 100.50% CLARITY OF SOLUTION AND REACTION CLEAR AND CLEAR AND CONGEALING TEMPERATURE 39�C WATER DETERMINATION 0.50% NONVOLATILE RESIDUE 0.05% ELEMENTAL IMPURITIES AS...
Ethylcellulose 10 mPa.s NF
Test Specification Min Max ASSAY (ETHOXY GROUPS: -OC[@2@]H[@5@]; DRIED BASIS) 44 51.00% CAPILLARY VISCOSITY 8 12.0 mPa.s ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST LOSS ON DRYING 3.00%...
Triacetin USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% ORGANIC IMPURITIES: ACETIC ACID 0.10% GLYCEROL 0.10% 1-MONOACETIN 0.10% 2-MONOACETIN 0.10% 1,3-DIACETIN 0.10% 1,2-DIACETIN 0.10% INDIVIDUAL UNSPECIFIED IMPURITY 0.10% TOTAL IMPURITIES...
L-Menthol Crystal USP
Test Specification Min Max ASSAY 98 102.00% MELTING RANGE 41 44�C SPECIFIC ROTATION [a][@D@]25 -45� to -51� -45� to -51� NONVOLATILE RESIDUE 0.05% RELATED COMPOUNDS TO PASS TEST ELEMENTAL IMPURITIES...
Emulsifying Wax NF
Test Specification Min Max MELTING RANGE 50� 54�C HYDROXYL VALUE 178 192 pH (in aqueous dispersion) 5.5 7 IODINE VALUE 3.5 SAPONIFICATION VALUE 14 ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
White Wax Cake NF
Test Specification Min Max MELTING RANGE 62� 65�C SAPONIFICATION CLOUD TEST TO PASS TEST TO PASS TEST FATS OR FATTY ACIDS, JAPAN WAX,[nROSIN AND SOAP TO PASS TEST TO PASS...
Vanillin NF
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% MELTING RANGE 81� 83�C LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.05% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED ARSENIC...
