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SimpliPure™ Pharmaceutical Ultra-Pure Lactose

1 of 3 products in this brand
SimpliPure™ Pharmaceutical Ultra-Pure Lactose is a crystalline alpha monohydrate lactose manufactured utilizing a proprietary crystallization and purification process yielding a product that is annatto-free, odorless, ultrawhite in powder form, and clear in solution.

Functions: Carrier, Sweetener

Dosage Form: Orally Disintegrating Tablets (ODTs)

Technical Data Sheet
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Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
Ingredients
Alpha Monohydrate Lactose
Ingredient and Allergen Statement

Product derived from pasteurized permeate (derived from Milk).

Features & Benefits

Food Ingredients Features

Applications & Uses

Applications

Formulated specifically to meet pharmaceutical, cosmetic, and enteric applications.

Properties

Color
Physical Form
Appearance
Free flowing powder
Odor
Fresh, No off odors
Flavor
Clean, Blend
Typical Properties
ValueUnitsTest Method / Conditions
Ash Content0.2%SMEDP 15.041
Bulk Density0.90 - 0.92g/mlTap Density
Hazemax. 5%Hunter Labs
Lactose99.7%Calculation
Mesh Size100.0Ro-Tap
Moisture Contentmax. 5.5%AOAC 925.45
pH Value4.5 - 7.2SMEDP 15.022
Protein Content0.15%AOAC 991.20
Scorched Particles15.0mgADPI
Water Activitymax. 0.2AquaLab
Microbiological Values
ValueUnitsTest Method / Conditions
Coagulase Positive StaphylococcusNot Detectedcfu/gAOAC 2003.08
Coliformsmax. 10cfu/gSMEDP 7.020
Escherichia colimax. 10cfu/gSMEDP 7.074
Enterobacteriaceaemax. 10cfu/g
ListeriaNot Detectedcfu/gAOAC 2013.14
Salmonella (per 375g)Not DetectedAOAC 2013.14
Standard Plate Countmax. 2,500cfu/gSMEDP 6.020
Yeast and Mold Countmax. 50cfu/gSMEDP 8.150

Regulatory & Compliance

Regulatory and Compliance

Codex 212-1999, FDA, USDA, ISO/IEC 17025.

Antibiotics

All raw milk used in the manufacture of products has been screened and tested “Not Found” for drug residues according to the FDA Pasteurized Milk Ordinance (PMO) – Appendix “N” (latest revision).

Quality Assurance

Manufacturing plants are subject to rules and regulations of the United States Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA). The manufacture, storage, and distribution processes have been designed and are implemented to ensure product quality and food safety.

Packaging & Availability

Availability

All products are available in bulk:

  • Truckload
  • 50 lb bags and totes.
  • 25 kg bags and totes.
  • 20 kg bags and totes.

Storage & Handling

Storage

The Product is packaged in poly lined multiwall 25 kg (net weight) kraft white paper bag without the use of staples or metal fasteners. It is recommended that the product is stored at 80°F or less, with a relative humidity of 65% or less, and in an odor-free environment. Stocks should be used in rotation preferably within 24 months of manufacture or as dictated by the expiration date labeled on the product.