SimpliPure™ Pharmaceutical Ultra-Pure Lactose
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.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Carrier
- Sweetener
Product families
- Carriers & Bulking Agents
- Flavors & Taste Maskers
Other characteristics
- Brand
- SimpliPure
- Functions
- Carrier, Sweetener
- Dosage Form
- Orally Disintegrating Tablets (ODTs)
- Odor
- Fresh, No off odors
- Color
- White
- Flavor
- Clean, Blend
- Markets
- Healthcare & Pharma
- 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.
- Appearance
- Free flowing powder
- Ingredient
- Alpha Monohydrate Lactose
- Technology
- Pharmaceuticals & Nutraceuticals
- Ingredient Name
- Alpha Monohydrate Lactose
- 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.
- Food Ingredients Features
- Odorless
- Regulatory Compliance
- Codex 212-1999, FDA, USDA, ISO/IEC 17025.
- Ingredient and Allergen Statement
Product derived from pasteurized permeate (derived from Milk).
Technical data
Table 1 of 2
10 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Ash Content | 0.2 | % | SMEDP 15.041 |
| Bulk Density | 0.90 - 0.92 | g/ml | Tap Density |
| Haze | max. 5 | % | Hunter Labs |
| Lactose | 99.7 | % | Calculation |
| Mesh Size | 100.0 | — | Ro-Tap |
| Moisture Content | max. 5.5 | % | AOAC 925.45 |
| pH Value | 4.5 - 7.2 | — | SMEDP 15.022 |
| Protein Content | 0.15 | % | AOAC 991.20 |
| Scorched Particles | 15.0 | mg | ADPI |
| Water Activity | max. 0.2 | — | AquaLab |
Table 2 of 2
8 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Coagulase Positive Staphylococcus | Not Detected | cfu/g | AOAC 2003.08 |
| Coliforms | max. 10 | cfu/g | SMEDP 7.020 |
| Escherichia coli | max. 10 | cfu/g | SMEDP 7.074 |
| Enterobacteriaceae | max. 10 | cfu/g | — |
| Listeria | Not Detected | cfu/g | AOAC 2013.14 |
| Salmonella (per 375g) | Not Detected | — | AOAC 2013.14 |
| Standard Plate Count | max. 2,500 | cfu/g | SMEDP 6.020 |
| Yeast and Mold Count | max. 50 | cfu/g | SMEDP 8.150 |
