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C12H22O11•H2O
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Description Back to Top
Lactose, Monohydrate, Powder, NF is used to help form tablets because it has excellent compressibility properties and as a diluent powder for dry-powder inhalations. All Spectrum Chemical NF grade products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP).
Specifications Back to Top
Test | Specification | |
---|---|---|
Min | Max | |
CLARITY AND COLOR OF SOLUTION | TO PASS TEST | |
SPECIFIC ROTATION [a]D | +54.4° to+55.9° | |
ACIDITY / ALKALINITY | TO PASS TEST | |
WATER DETERMINATION | 4.5 | 5.5 % |
MICROBIAL LIMITS: | ||
TOTAL AEROBIC MICROBIAL COUNT | 10²cfu/g | |
TOTAL MOLDS AND YEASTS | 5x10¹cfu/g | |
TEST FOR E. COLI | NEGATIVE | |
LOSS ON DRYING | 0.5 % | |
RESIDUE ON IGNITION | 0.1 % | |
PROTEIN & LIGHT-ABSORBING IMPURITIES | TO PASS TEST | |
ELEMENTAL IMPURITIES | AS REPORTED | |
IDENTIFICATION | TO PASS TEST | |
CERTIFIED KOSHER-DAIRY | ||
EXPIRATION DATE | ||
DATE OF MANUFACTURE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | AS REPORTED | |
MONOGRAPH EDITION |
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Shipping & Storage Back to Top