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C12H22O11•H2O
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Description Back to Top
Lactose, Monohydrate, Spray-Dried 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 | 0.04 | |
SPECIFIC ROTATION [a]D | +54.4° +55.9° | |
ACIDITY OR ALKALINITY | 0.4 ml | |
WATER DETERMINATION | 4.5 | 5.5 % |
MICROBIAL LIMITS: | ||
TOTAL AEROBIC MICROBIAL COUNT (TAMC) | 10² cfu/g | |
TOTAL MOLDS AND YEASTS | 5X10¹ cfu/g | |
TEST FOR ESCHERICHIA COLI | NEGATIVE | |
LOSS ON DRYING | 1.0 % | |
RESIDUE ON IGNITION | 0.1 % | |
PROTIEN AND LIGHT ABSORBING | AS REPORTED | |
@210 - 220 nm | 0.25 nm | |
@270 - 300 nm | 0.07 nm | |
ELEMENTAL IMPURITIES | AS REPORTED | |
IDENTIFICATION (A) | SPECTRUM MATCHES REFERENCE | |
IDENTIFICATION (B) | Rf MATCHES STANDARD | |
CERTIFIED KOSHER-DAIRY | ||
EXPIRATION DATE | ||
DATE OF MANUFACTURE | ||
APPEARANCE | ||
RESIDUAL SOLVENTS | AS REPORTED |
Certifications Back to Top
Shipping & Storage Back to Top