Test Specification Min Max SOLUBILITY AND REACTION TO PASS TEST TO PASS TEST BOTANICAL CHARACTERISTICS TO PASS TEST TO PASS TEST MICROBIAL LIMITS TO PASS TEST TO PASS TEST SALMONELLA...
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...
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...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 92.0� 97.0� SPECIFIC ROTATION, [a][@D@]25 +1� to -1� +1� to -1� LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS...
Test Specification Min Max ASSAY (C[@4@]H[@9@]NO[@3@]; DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION, [a] 20D -26.5 to-29.0 -26.5 to-29.0 LEAD 5 mg/kg LOSS ON DRYING...
Test Specification Min Max ANGULAR ROTATION +8 to +15 +8 to +15 REFRACTIVE INDEX 1.462- 1.472 1.462- 1.472 SOLUBILITY IN ALCOHOL TO PASS TEST TO PASS TEST SPECIFIC GRAVITY @...
Test Specification Min Max ASSAY 60.0 - 75.0 % 60.0 - 75.0 % ANGULAR ROTATION -2 to +3 -2 to +3 REFRACTIVE INDEX @ 20[dC 1.506- 1.512 1.506- 1.512 SOLUBILITY...
Test Specification Min Max ANGULAR ROTATION -7 to -33 -7 to -33 REFRACTIVE INDEX @ 20[dC 1.493 1.5 SPECIFIC GRAVITY @ 25[dC 0.88 0.907 GURJUN OIL NONE DETECTED NONE DETECTED...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION +38.6 to+41.5 +38.6 to+41.5 LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.30% RESIDUE...
Test Specification Min Max ASSAY (C[@15@]H[@15@]NO[@2@]; DRIED BASIS) 99 101.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST COPPER (Cu) 10 ppm LOSS ON DRYING 0.50% SULPHATED ASH 0.10% ELEMENTAL...
Test Specification Min Max ASSAY (ALDEHYDES AS CITRAL) 75.00% ANGULAR ROTATION -10� to 0� -10� to 0� REFRACTIVE INDEX @ 25[dC 1.483 - 1.489 1.483 - 1.489 SOLUBILITY IN ALCOHOL...
Test Specification Min Max ASSAY (DRIED BASIS) 97.0-103.0 % 97.0-103.0 % MELTING RANGE (MAX. 2[dC) 178 - 185 C 178 - 185 C LOSS ON DRYING 0.50% RESIDUE ON IGNITION...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.0-102.0 % 98.0-102.0 % WATER 3.0- 12.0 % 3.0- 12.0 % CHLORIDE (Cl) 0.05% LEAD (Pb) 2 mg/kg REDUCING SUBSTANCES 1.00% SULFATE 0.05%...
Test Specification Min Max ANGULAR ROTATION +91 to +96 +91 to +96 REFRACTIVE INDEX @ 20[dC 1.475 - 1.478 1.475 - 1.478 RESIDUE ON EVAPORATION 5.0 - 10.0 % 5.0...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 3 4.50% pH 3.5 5 ORGANIC IMPURITIES TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 0.30% HEAVY...
Test Specification Min Max ASSAY 98.5 101.50% CLARITY AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 20% SOLUTION 3 5.5 ORGANIC IMPURITIES TO PASS TEST...
Test Specification Min Max ASSAY 400 USP oxytocin 400 USP oxytocin ACETIC ACID 6 10% MICROBIAL LIMITS 200 cfu/g ORDINARY IMPURITIES 5% ELEMENTAL IMPURITIES: PALLADIUM (Pd) AS REPORTED AS REPORTED...
Test Specification Min Max ASSAY (C[@28@]H[@44@]O) 97 103.00% MELTING RANGE 115 119�C SPECIFIC ROTATION [a][@D@] +103� to +106� +103� to +106� REDUCING SUBSTANCES TO PASS TEST TO PASS TEST ELEMENTAL...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 5 8.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TEST 2: PANTOPRAZOLE RELATED COMPOUND C 0.10% PANTOPRAZOLE RELATED...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95.0 - 102.0 % 95.0 - 102.0 % LEAD (Pb) 2 mg/kg RESIDUE ON IGNITION 0.30% WATER 8.50% IDENTIFICATION TO PASS TEST EXPIRATION...
Test Specification Min Max ASSAY (ALDEHYDES AS DECYL ALDEHYDE) 1.2 2.50% ANGULAR ROTATION +94� to +99� +94� to +99� REFRACTIVE INDEX @ 20[dC 1.472 1.474 SPECIFIC GRAVITY @ 25[dC 0.842...
TestSpecificationMinMaxASSAY (Na[@2@]CO[@3@]; DRY BASIS)99.5100.50%LOSS ON DRYING1215.00%LEAD (Pb)4 mg/kgIDENTIFICATIONTO PASS TESTEXPIRATION DATE
Test Specification Min Max ASSAY (ANHYDROUS) 98 101.00% CLARITY AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST WATER 12% RELATED SUBSTANCES TO PASS TEST TO PASS TEST IDENTIFICATION...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% OPTICAL ROTATION, [a] 20D -0.10 to +0.10 -0.10 to +0.10 RESIDUE ON IGNITION 0.10% LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES . . TINIDAZOLE RELATED COMPOUND A 0.20%...
Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% MELTING RANGE 114� - 117�C 114� - 117�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL...
Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 100.5% 97.0 - 100.5% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.10% ELEMENTAL...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% MELTING RANGE (WITHIN 4�C) 162� 171�C pH OF A 10% SOLUTION 6.4 6.8 WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.20% SELENIUM...
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% pH OF A 1 IN 10 SOLUTION 2 3 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]20 -28.6 to -35.0 -28.6 to -35.0 WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.20% SULFAMATE 0.10% SULFATE 0.10% ELEMENTAL...
Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% LOSS ON DRYING 55 64.00% INSOLUBLE SUBSTANCES 0.40% CHLORIDE (Cl) 0.06% SULFATE 0.20% ARSENIC (As) 16 ppm ELEMENTAL IMPURITIES AS REPORTED...
Test Specification Min Max ASSAY (C[@6@]H[@14@]N[@2@]O[@2@].HCl; DRIED BASIS) 98.5 101.50% OPTICAL ROTATION, @ 20D +20.3 to +21.5 +20.3 to +21.5 LEAD 5 mg/kg LOSS ON DRYING 1.00% RESIDUE ON IGNITION...
Test Specification Min Max ASSAY (DRIED BASIS) 98.0-102.0 % 98.0-102.0 % CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS...
TestSpecificationMinMaxASSAY (C[@7@]H[@8@]O[@3@]); ANHYDROUS BASIS99.00%RESIDUE ON IGNITION0.20%WATER0.50%IDENTIFICATIONTO PASS TESTTO PASS TESTCERTIFIED KOSHERCERTIFIED HALALEXPIRATION DATE