Test Specification Min Max ASSAY (KHCO[@3@]) 99.5 101.50% LOSS ON DRYING (OVER SILICA) 0.30% NORMAL CARBONATE 2.50% ELEMENTAL IMPURITIES: COBALT (Co) AS REPORTED ANTIMONY (Sb) AS REPORTED TIN (Sn) AS...

Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.01% SULFATE TO PASS TEST AMMONIUM SALTS TO PASS TEST ELEMENTAL...

Test Specification Min Max ASSAY (H[@2@]O[@2@]) 35.00% ACIDITY (as H[@2@]SO[@4@]) 0.03% IRON (Fe) 0.5 mg/kg LEAD (Pb) 4 mg/kg PHOSPHATE (PO[@4@]) 0.01% RESIDUE ON EVAPORATION 0.01% TIN (Sn) 10 mg/kg...

Test Specification Min Max ASSAY 99 100.50% SPECIFIC ROTATION [a][@D@] +20.5 to+21.5 +20.5 to+21.5 RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED LEAD (Pb) AS REPORTED ARSENIC (As)...

Test Specification Min Max ASSAY (KETONES AS THUJONE) 60% 60% ANGULAR ROTATION -7 to -14 -7 to -14 REFRACTIVE INDEX @ 20[dC 1.456- 1.460 1.456- 1.460 SOLUBILITY IN ALCOHOL TO...

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...

Test Specification Min Max ASSAY 99.5 100.50% SOLIDIFICATION POINT 15.6�C NONVOLATILE RESIDUE 0.01% LEAD (Pb) 0.5 mg/kg READILY OXIDIZABLE SUBSTANCES TO PASS TEST IDENTIFICATION TO PASS TEST CERTIFIED KOSHER CERTIFIED...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% MELTING RANGE 168� 172�C pH OF A 5% SOLUTION @ 25[dC 10 11.5 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10%...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 5% SOLUTION 6 7.8 WATER DETERMINATION 3 12.00% CHLORIDE 0.05% SULFATE 0.05% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% ACIDITY / ALKALINITY 0.5 ml LOSS ON DRYING 0.50% CHLORIDE (Cl) 0.02% APPEARANCE OF SOLUTION CLEAR LESS CLEAR LESS ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 100.50% WATER DETERMINATION 10 13.00% ALKALINITY TO PASS TEST TO PASS TEST TARTRATE TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] (DRIED BASIS) +21.3� to +23.5 +21.3� to +23.5 RESIDUE ON IGNITION 0.10% LOSS ON DRYING 0.30% LEAD (Pb)...

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%...

Test Specification Min Max CARBON NUMBER AT 5% DISTILLATION POINT 17 - 25 17 - 25 SPECIFIC GRAVITY 0.848 - 0.867 0.848 - 0.867 UV ABSORBANCE (POLYNUCLEAR HYDROCARBONS) TO PASS...

Test Specification Min Max SPECIFIC GRAVITY @ 25[dC 0.818 0.88 VISCOSITY @40.0�C 3.0 -34.4 mm�/s 3.0 -34.4 mm�/s ACIDITY TO PASS TEST TO PASS TEST READILY CARBONIZABLE SUBSTANCES TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0- 101.0 % 99.0- 101.0 % ALKALINITY (as NaOH) 0.20% LEAD (Pb) 2 mg/kg LOSS ON DRYING 1.00% POTASSIUM COMPOUNDS TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE 296� 303�C CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SELENIUM (Se) 0.00% ELEMENTAL...

Test Specification Min Max ASSAY 99.3 101.80% INSOLUBLE SUBSTANCES 0.01% CHLORIDE (Cl) 20 ppm NITRATE (NO[@3@]) TO PASS TEST TO PASS TEST SULFATE 200 ppm ARSENATE, PHOSPHATE & SILICATE 10...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95 105.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% FOREIGN PROSTAGLANDINS, TEST 1 TO PASS TEST TO PASS TEST FOREIGN PROSTAGLANDINS, TEST 2...

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...

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...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH of 10 % SOLUTION 5 7 WATER DETERMINATION 3.9 4.40% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (ZnO) 99.00% ALKALINITY TO PASS TEST TO PASS TEST CADMIUM (Cd) 3 mg/kg LEAD (Pb) 10 mg/kg LOSS ON IGNITION 1.00% SUBSTANCES NOT Pptd. by...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 101.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED REDUCING SUGARS 0.20% OTHER POLYOLS 2.00% IDENTIFICATION TO PASS TEST...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97.0 - 102.0 % 97.0 - 102.0 % CADMIUM (Cd) 2 mg/kg CHLORIDE (Cl) 0.05% LEAD (Pb) 2 mg/kg REDUCING SUBSTANCES 1.00% SULFATE...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.25% ALKALIES AND ALKALINE EARTHS 1.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE...

Test Specification Min Max ASSAY (ZnO) 12.5 14.00% ALKALIES AND ALKALINE EARTHS 1.00% ARSENIC 1.5 ppm LEAD 10 ppm ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED AS REPORTED MERCURY (Hg) AS...

Test Specification Min Max ASSAY 97 100.50% OXYCHLORIDE SOLUTION BECOMES SOLUTION BECOMES SULFATES (SO[@4@]) 0.03% ALKALIES AND ALKALINE EARTHS 1.00% AMMONIUM SALTS NO ODOR OF AMMON NO ODOR OF AMMON...

Test Specification Min Max ACID VALUE 18 - 24 18 - 24 CARNAUBA WAX TO PASS TEST TO PASS TEST ESTER VALUE 72 - 77 72 - 77 FATS OR...

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...

Test Specification Min Max ASSAY 96 102.00% ACIDITY TO PASS TEST ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED AS REPORTED LEAD (Pb) AS REPORTED AS REPORTED ARSENIC (As) AS REPORTED AS...

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...

Test Specification Min Max POTENCY (AS VANCOMYCIN) 900 �g/mg pH OF A 50 mg/ml SOLUTION @ 25[dC 2.5 4.5 COMPOSTION OF VANCOMYCIN TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]25 +18.2 to+19.4� +18.2 to+19.4� COLOR OF A 10% SOLUTION TO PASS TEST LOSS ON DRYING 0.10% ORGANIC IMPURITIES...

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...

Test Specification Min Max ASSAY (USP) 98 102.00% ASSAY (JP) 99.00% MELTING POINT (JP) 132.5 134.5�C RESIDUE ON IGNITION 0.10% ALCOHOL-INSOLUBLE MATTER 0.04% CHLORIDE 0.01% SULFATE 0.01% ELEMENTAL IMPURITIES AS...