Lactose Monohydrate BiotechGrade omega-Alkanedicarboxylic Acids Test Specification Min Max ASSAY

Test Specification Min Max ASSAY (HPLC) 94% MELTING POINT 286

00% MICROBIAL LIMITS: TOTAL PLATE COUNT 5000/g YEAST AND MOLD 500/g ESCHERICHIA COLI NEGATIVE SALMONELLA NEGATIVE

0% SPECIFIC ROTATION (C=10

Test Specification Min Max ABSORPTION MAX 522 nm 522 nm VISUAL TRANSITION INTERVALS pH1

25% IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE

Lactose Monohydrate BiotechGrade omega-Alkanedicarboxylic Acids Test Specification Min Max ASSAYTest Specification Min Max APPEARANCE FINE,WHITE POWDE FINE,WHITE POWDE 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 ALKALINITY TO PASS TEST TO PASS TEST WATER 4. 5 5. 5% 4. 5 5. 5% INSOLUBLE MATTER 0. 01% LOSS ON DRYING @ 80[dC 0. 50% RESIDUE ON IGNITION 0. 10% IRON (Fe) 5 ppm HEAVY METALS 5 ppm PROTEIN & LIGHT ABSORBING IMPURITIES TO PASS TEST TO PASS TEST ENDOTOXIN