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C12H22O11•H2O
Catalog Size Package Availability Manufacturer List Price Unit
LA105-500GM 500 GM Spectrum Chemical $93.00 EA
LA105-2.5KG 2.5 KG Spectrum Chemical $336.00 EA
LA105-12KG 12 KG Spectrum Chemical $618.00 EA
LA105-25KGBL 25 KG Spectrum Chemical $995.00 EA

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

  • 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

Shipping Information

Tariff No. 1702190000

Shipping Costs
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LA105 has a rating of 5 stars based on 7 reviews.