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) 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...
TestSpecificationMinMaxCLARITY OF SOLUTIONTO PASS TESTTO PASS TESTVISUAL TRANSITION INTERVALSpH 6.8 (red) topH 6.8 (red) to
TestSpecificationMinMaxASSAY (C[@6@]H[@13@]NO[@2@])99%99%LOSS ON DRYING @ 105 C0.30%RETEST DATE
TestSpecificationMinMaxVISUAL TRANSITION INTERVALSpH 10.1(yellow)pH 10.1(yellow)EXPIRATION DATE
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...
TestSpecificationMinMaxSPECIFIC ROTATION [a][@D@]+160 +/- 5+160 +/- 5
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...