Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE (MAX. 3 C RANGE) 231 242�C SPECIFIC ROTATION [a][@D@] +29.0 to +32.5� +29.0 to +32.5� MICROBIAL LIMITS TO PASS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95 102.00% WATER DETERMINATION 42 48.00% SULFATES (SO[@4@]) TO PASS TEST ALKALIES AND ALKALINE EARTHS 0.50% IRON (Fe) 10 ppm ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] +21 to +27 +21 to +27 pH OF A 1 IN 100 SOLUTION 2 2.8 LOSS ON DRYING...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.20% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED ARSENIC (As) AS REPORTED AS...

TestSpecificationMinMaxASSAY98%TURBIDITYClear at 50mg /Clear at 50mg /Solubility (Color)YellowYellowRETEST DATE

TestSpecificationMinMaxAPPEARANCE

Test Specification Min Max ASSAY 64.00% pH OF A 14 % SOLUTION 5 7.5 WATER 28.5 31.50% LEAD 1 mg/kg NICKEL 1 mg/kg REDUCING SUGARS 0.30% RESIDUE ON IGNITION 0.10%...

TestSpecificationMinMaxASSAYAPPROX. 97 %APPROX. 97 %RETEST DATE

TestSpecificationMinMaxPURITY (GC)97%97%SPECIFIC GRAVITY (20/20)1.1080 - 1.11201.1080 - 1.1120REFRACTIVE INDEX (n20/D)1.4020 - 1.40501.4020 - 1.4050

TestSpecificationMinMaxSPECIFIC SURFACE AREA (BET)175225 m2/gLOSS ON DRYING1.50%

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a]D25 +150� to +156� +150� to +156� PARTICLE SIZE (THROUGH 15 micron) 90% LOSS ON DRYING 1.00% RESIDUE ON...

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...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% CONTENT OF PAMOIC ACID (DRIED BASIS) 63.4 67.30% LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% MELTING RANGE 173� 179�C SPECIFIC ROTATION [a][@D@]25 +76� to +83� +76� to +83� PARTICLE SIZE (THROUGH 20 micron) 92% WATER DETERMINATION...

Test Specification Min Max PHOSPHATIDYL CHOLINE 92% LYSO-PHOSPHATIDYLCHOLINE 3 +/- 3 % 3 +/- 3 % (+/-)-alpha-TOCOPHEROL 0.10% PEROXIDE VALUE 5 ACID VALUE 0.5 ETHANOL 0.50% WATER 1.50% RETEST DATE...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% CHLORIDE CONTENT (DRIED BASIS) 8 10% LOSS ON DRYING 3% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% pH OF A 1 IN 100 SOLUTION 4.5 6 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES: PALLADIUM (Pd)...

Test Specification Min Max ASSAY (C[@20@]H[@17@]FO[@3@]S; DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO...

Test Specification Min Max ASSAY 99 100.50% ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% BROMIDE 0.10% IODIDE 0.01% CALCIUM AND MAGNESIUM TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 100.5 % 98.0 - 100.5 % LOSS ON DRYING 5.00% INSOLUBLE SUBSTANCES 0.40% CHLORIDE (Cl) 0.06% SULFATES (SO[@4@]) 0.20% ARSENIC (As)...

TestSpecificationMinMaxASSAY (NaNO[@3@]; DRIED BASIS)99100.50%LEAD (Pb)4 mg/kgTOTAL CHLORINETO PASS TESTIDENTIFICATIONTO PASS TESTRETEST DATE

TestSpecificationMinMaxASSAY97.00%97.00%

TestSpecificationMinMaxASSAY99%WATER0.30%

Test Specification Min Max ASSAY (DRIED BASIS) 95.0-100.5 % 95.0-100.5 % LOSS ON IGNITION 30.0- 33.0 % 30.0- 33.0 % FREE ALKALI & SOLUBLE SALTS TO PASS TEST TO PASS...

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...

Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% ALKALINITY TO PASS TEST WATER DETERMINATION 1.00% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE...

TestSpecificationMinMaxAPPEARANCEEXPIRATION DATEDATE OF MANUFACTURE

Test Specification Min Max FDA LOT NUMBER DYE CONTENT HEAVY METAL: ARSENIC (As) TO PASS TEST TO PASS TEST LEAD (Pb) TO PASS TEST TO PASS TEST MERCURY (Hg) TO...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99.5 100.50% CLARITY OF SOLUTION TO PASS TEST TO PASS TEST COLOR OF SOLUTION TO PASS TEST TO PASS TEST WATER DETERMINATION 1.00%...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxPROTEASE ACTIVITY75 U.S.P.UNITS/m75 U.S.P.UNITS/mFAT6%MICROBIAL LIMITS:TOTAL PLATE COUNT10000/gESCHERICHIA COLINEGATIVESALMONELLANEGATIVEEXPIRATION DATE

TestSpecificationMinMaxAPPEARANCEEXPIRATION DATEDATE OF MANUFACTURE