TestSpecificationMinMaxASSAY99.0-101.0%99.0-101.0%LOSS ON DRYING6.0-10.0%6.0-10.0%ALKALOIDSTO PASS TESTTO PASS TESTSULFATES (SO[@4@])500 ppmRETEST DATE

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 3.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED REDUCING SUBSTANCES 1.00% IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION +25.2 to+25.8 +25.2 to+25.8 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.25% LEAD...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% TRANSMITTANCE @430 nm TO PASS TEST SPECIFIC ROTATION [a][@D@] +14.5 to+16.5 +14.5 to+16.5 LOSS ON DRYING 4.50% RESIDUE ON IGNITION 0.20%...

Test Specification Min Max ASSAY (JP) 99.50% ASSAY (ANHYDROUS BASIS; EP, USP) 97.5 102% ACIDITY RED COLOR RED COLOR LOSS ON DRYING (JP) 1.00% WATER (EP) 1.00% COLOR AND CLARITY...

Test Specification Min Max ACTIVITY 98.0 - 101.0 % 98.0 - 101.0 % HYDROCHLORIDE CONTENT 25 - 27 % 25 - 27 % MELTING POINT 188� -194�C 188� -194�C MOISTURE...

TestSpecificationMinMaxASSAY99%

Test Specification Min Max CLARITY AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST SPECIFIC ROTATION [a][@D@] 110.3 110.3 ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST WATER...

Test Specification Min Max ASSAY (DRIED BASIS) 97.00% 97.00% MELTING RANGE 224 - 227 C 224 - 227 C CALCIUM (Ca) TO PASS TEST CHLORIDE (Cl) 0.01% LEAD (Pb) 4...

Test Specification Min Max ASSAY 99 101.00% LEAD (Pb) 10 ppm ELEMENTAL IMPURITIES AS REPORTED REDUCING SUBSTANCES TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE...

TestSpecificationMinMaxABSORPTION MAX520 (357) nm520 (357) nm

Test Specification Min Max ASSAY: STEARIC ACID 40 60.00% ASSAY: STEARIC ACID & PALMITIC ACID 90.00% FREEZING POINT 53� 59�C IODINE VALUE 4 RESIDUE AFTER IGNITION 0.10% ELEMENTAL IMPURITIES: NICKEL...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@]25 +14.9�to+17.3� +14.9�to+17.3� pH OF A 1 IN 100 SOLUTION 5.5 7 LOSS ON DRYING 0.20% RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] +100� to +105� +100� to +105� CHROMATOGRAPHIC PURITY: . . SINGLE 1.00% TOTAL 2.00% LOSS ON DRYING 1.00%...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxDEACETYLATION90.00%MOISTURE10.00%ASH5.00%

Test Specification Min Max ASSAY (C[@6@]H[@7@]NaO[@6@]) 99 101.00% pH OF A 10% SOLUTION 7 8 SPECIFIC ROTATION [a][@D@]25 +103� to +108� +103� to +108� LOSS ON DRYING 0.25% ELEMENTAL IMPURITIES:...

TestSpecificationMinMaxAPPEARANCEWHITE TO YELLOWIWHITE TO YELLOWIWATER2%

Test Specification Min Max ASSAY 98.5 102.00% LOSS ON DRYING 2.00% CHLORIDE (Cl) 0.07% SULFATE 0.05% ARSENIC (As) 3 ppm ELEMENTAL IMPURITIES AS REPORTED REDUCING SUBSTANCES 1.00% IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY 95 105.00% SPECIFIC GRAVITY 1.005 1.013 REFRACTIVE INDEX @ 20�C 1.542 1.548 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST ACIDITY TO PASS TEST TO...

Test Specification Min Max ASSAY 97.5 102.00% SPECIFIC ROTATION, [a][@D@]25 +89� to +93� +89� to +93� RELATED COMPOUNDS: INDIVIDUAL IMPURITY 1.00% TOTAL IMPURITIES 2.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

TestSpecificationMinMaxACTIVITY (CMCase)? CMC units/g? CMC units/gACTIVITY

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 105� 107�C LOSS ON DRYING (OVER SILICA) 0.30% RESIDUE AFTER IGNITION 0.10% ORDINARY IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (C[@9@]H[@8@]O[@4@]) 99.5 100.50% LOSS ON DRYING 0.50% READILY CARBONIZABLE SUBSTANCES NO MORE NO MORE RESIDUE ON IGNITION 0.05% SUBSTANCES INSOLUBLE IN SODIUM CARBONATE SOLUTION IS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SELENIUM (Se) 0.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED DIAZOTIZABLE SUBSTANCES 2.50% IDENTIFICATION...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 96 102.00% SPECIFIC ROTATION, [a][@D@]25 +95� to +102� +95� to +102� pH OF A 1 IN 100 SOLUTION 7.5 10.5 WATER DETERMINATION 6.50%...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +112 to +119 +112 to +119 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% ELEMENTAL IMPURITIES: NICKEL...

TestSpecificationMinMaxAPPEARANCE

Test Specification Min Max ASSAY (C[@29@]H[@50@]O[@2@]) 96 102.00% ACIDITY TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION A TO PASS TEST TO PASS TEST IDENTIFICATION...