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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. Spectrum Chemical NF products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
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