Test Specification Min Max ASSAY APPROX. 95% APPROX. 95%

Test Specification Min Max NO SPECIFICATIONS

Test Specification Min Max ASSAY 98% 98%

Test Specification Min Max APPEARANCE

Test Specification Min Max ABSORPTIVE POWER TO PASS TEST TO PASS TEST REACTION TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 4.00% ACID-SOLUBLE SUBSTANCES 3.50% ALCOHOL-SOLUBLE SUBSTANCES 0.20% UNCARBONIZED...

Test Specification Min Max ASSAY (ANHYDROUS, SOLVENT-FREE BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]25 +96.0??to +100. +96.0??to +100. WATER DETERMINATION 0.30% RESIDUE OF IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST SPECIFIC ROTATION -0.2??to +0.2??/td> -0.2??to +0.2??/td> pH 5.5 6.5 WATER DETERMINATION 0.50%...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97%

Test Specification Min Max ASSAY (DRIED BASIS) 98.0-102.0 % 98.0-102.0 % LOSS ON DRYING 2.0 - 5.7 % 2.0 - 5.7 % FREE UNDECYLENIC ACID 0.10% EXPIRATION DATE

Test Specification Min Max ASSAY 96.00% TITRABLE BASE 0.006 meq/

Test Specification Min Max ASSAY 95%

Test Specification Min Max POTENCY (CHYMOTRYPSIN; DRIED BASIS) 1000 USP units/m 1000 USP units/m ASSAY (OF LABELED POTENCY) 90.0 - 110.0 % 90.0 - 110.0 % MICROBIAL LIMITS: TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] -215??to -225??/td> -215??to -225??/td> LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.20% RESIDUE ON IGNITION 0.10% IDENTIFICATION TO...

Test Specification Min Max ASSAY 98 101.00% SPECIFIC ROTATION [a][@D@] +95??to +97??/td> +95??to +97??/td> pH OF A 1 IN 10 SOLUTION 6.8 7.4 LOSS ON DRYING 0.10% ARSENIC (As) 3...

Test Specification Min Max APPEARANCE

Test Specification Min Max ASSAY (Cu) 99.90% INSOLUBLE IN HNO[@3@] 0.02% ANTIMONY AND TIN (as Sn) 0.01% ARSENIC (As) 5 ppm IRON (Fe) 0.01% LEAD (Pb) 0.01% MANGANESE (Mn) 0.00%...

Test Specification Min Max CLARITY OF SOLUTION TO PASS TEST TO PASS TEST SENSITIVITY TO NITRATE TO PASS TEST TO PASS TEST SENSITIVITY TO FORMALDEHYDE TO PASS TEST TO PASS...

Test Specification Min Max POTENCY 390 ??/mg 390 ??/mg pH 6.5 - 8.5 6.5 - 8.5 LOSS ON DRYING 7.00% HEAVY METALS 0.00% FREE COLISTINE TO PASS TEST TO PASS...

Test Specification Min Max ASSAY (CaHPO[@4@] 2H[@2@]O) 97 105.00% LOSS ON IGNITION 24.5 26.50% ARSENIC (As) 3 mg/kg FLUORIDE 0.01% LEAD (Pb) 2 mg/kg IDENTIFICATION TO PASS TEST CERTIFIED HALAL...

Test Specification Min Max pKa @ 25[dC APPROX. 9.6 APPROX. 9.6 pH OF A 1% SOLUTION 10.9 - 11.6 10.9 - 11.6

Test Specification Min Max APPEARANCE RETEST DATE

Test Specification Min Max pH of a 1 % Dispersion 5 7 DEGREE OF SUBSTITUTION (DRIED BASIS) 0.6 0.85 RESIDUE ON IGNITION 14 28.00% SETTLING VOLUME TO PASS TEST LOSS...

Test Specification Min Max ASSAY 90.00% LOSS ON DRYING 7.50% SENSITIVITY AS INDICATOR TO PASS TEST TO PASS TEST ABSORBANCE CHARACTERISTICS TO PASS TEST TO PASS TEST

Test Specification Min Max ASSAY (C[@12@]H[@22@]O[@14@]Cu) 98.0- 102.0 % 98.0- 102.0 % LEAD (Pb) 5 mg/kg REDUCING SUBSTANCES 1.00% IDENTIFICATION TO PASS TEST RETEST DATE

Test Specification Min Max ASSAY (CuSO[@4@][-5H[@2@]O) 98.0 - 102.0 % 98.0 - 102.0 % INSOLUBLE MATTER 0.01% CHLORIDE (Cl) 0.00% NITROGEN COMPOUNDS (as N) 0.00% IRON (Fe) 0.00% SODIUM (Na)...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% pH 5.5 9.5 WATER DETERMINATION 4.00% RESIDUE ON IGNITION 0.50% CHLORIDE 0.40% POTASSIUM 0.20% SODIUM 0.10% ENANTIOMERIC PURITY (as D-CARNITINE) 0.20%...

Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 102.0 % 97.0 - 102.0 % pH 5.0 - 7.5 5.0 - 7.5 LEAD (Pb) 2 mg/kg LOSS ON DRYING 7.00%...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] +5.7??to +6.8??/td> +5.7??to +6.8??/td> LOSS ON DRYING 8 12.00% RELATED COMPOUNDS TO PASS TEST TO PASS TEST RESIDUE...

Test Specification Min Max ASSAY (C[@6@]H[@12@]) 99.00% COLOR (APHA) 10 RESIDUE AFTER EVAPORATION 0.00% SUBSTANCES DARKENED BY (H[@2@]SO[@4@]) TO PASS TEST TO PASS TEST WATER 0.02% IDENTIFICATION TO PASS TEST...

Test Specification Min Max VISUAL TRANSITION INTERVALS pH 7.4 (yellow) pH 7.4 (yellow)

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +208??to +217??/td> +208??to +217??/td> LOSS ON DRYING 1.00% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ORGANIC IMPURITIES TO PASS TEST...

Test Specification Min Max ASSAY (Ca O[@2@]) 60.00% 60.00% FLUORIDE 0.01% LEAD (Pb) 4 mg/kg IDENTIFICATION TO PASS TEST TO PASS TEST

Test Specification Min Max ASSAY (CaHPO[@4@]) 98 101.00% LOSS ON IGNITION 7 8.50% ARSENIC (As) 3 mg/kg FLUORIDE 0.01% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED AS REPORTED VANADIUM (V) AS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% BENZOATE AND SALICYLATE TO PASS TEST LEAD 2 mg/kg READILY CARBONIZABLE SUBSTANCES TO PASS TEST SELENIUM 0.00% TOLUENESULFONAMIDES TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 103.0 % 97.0 - 103.0 % SPECIFIC ROTATION [a][@D@] +25.0 to+27.5 +25.0 to+27.5 CALCIUM CONTENT 8.2 - 8.6 % 8.2 -...

Test Specification Min Max ASSAY [Ca(NO[@3@])[@2@][-4H[@2@]O] 99.0 - 103.0 % 99.0 - 103.0 % pH OF A 5% SOLUTION @ 25[dC 5.0 - 7.0 5.0 - 7.0 INSOLUBLE MATTER 0.01%...