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products - with quality and delivery you can count on every time.
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C12H22O11•H2O
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Lactose, Monohydrate, Powder, NF
IMPORTANT UPDATE - All sales after March 2, 2020 are final and non-returnable for COVID-19 related items. Prices and delivery dates may fluctuate. Refer to T&Cs for more information.
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.
Synonyms:
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 | ||
Certifications Back to Top
- Certificate Of Analysis this document gives the exact details about the item's quality and compliance to specifications and relates specifically to the result of testing a representative sample drawn from the specific batch or lot material by Spectrum personnel.
- Kosher Certificate Spectrum-labeled kosher products with the Kosher Supervision of America symbol are a firm guarantee to all Spectrum customers that the products bearing the symbol are in full compliance with the most demanding of Kosher and Pareve standards.
- BSE / TSE Statement certifies that the product produced by Spectrum is free from Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE) and is manufactured wholly from synthetic or manufactured materials and do not contain any raw materials produced from or substances derived of animal origin.
- Residual Solvents Statement Spectrum certifies that this item meets the requirements found in USP-NF General Chapter <467> Residual Solvents / Organic Volatile Impurities.
- Country of Origin this is an item/lot specific document that certifies the goods have been wholly produced, manufactured or processed in a particular country.
Shipping & Storage Back to Top
Tariff No. 1702190000
Shipping Costs
