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KLEPTOSE® Linecaps 17 Pea Maltodextrin Cyclodextrin - Pharma

KLEPTOSE® LINECAPS Pea Maltodextrin Cyclodextrin can be used as a solubilizer, stabilizer and taste-making agent in pharma oral dosage applications. Applications Swallowable, chewable and effervescent tablets Lozenges Hard and soft capsules Orally dissolving films Blends Granules Pellets premix Medicated confectionery Syrups Suspensions Liquids Cream Paste Semi-solids

Brand: KLEPTOSE (15 products)

Chemical Name: Maltodextrin

CAS Number: 9050-36-6

Functions: Encapsulant, Solubilizer, Stabilizer, Taste Masker

Dosage Form: Capsules, Creams, Films, Granules, Lozenges, Orally Disintegrating Films (ODFs), Pellets, Powder & Powder Blends, Suspension, Syrups, Tablets

Labeling Claims: Non-Hazardous

Synonyms: Maltotab, Maltrin

Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Benefit Claims
Labeling Claims

Applications & Uses

Properties

Physical Form
Odor
Odorless
Appearance
White powder
Taste
Slightly sweet
Soluble in
Water
Typical Properties
ValueUnitsTest Method / Conditions
Average Mean Particle Diameter200µm-
pH Value4.0 - 7.0-EP / NF
Dextrose Equivalent15 - 20-EP / NF
Identification Test A (*)Complies-EP
Identification Test B (*)Complies-EP
Identification Test CComplies-EP
Identification Test DComplies-EP
Molecular Weight11500g/mol-
Protein Content (*)max. 0.1%NF
Residue on Ignitionmax. 0.5%NF
Sulfated Ash Content (*)max. 0.5%EP
Sulfur Dioxide Contentmax. 20mg/kgEP
Sulfur Dioxide Contentmax. 40mg/kgNF
Water Content (LOD)4.3 - 6%-
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Dryingmax. 6.0%EP / NF
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliNot detectedper gram-
Salmonella (**)Not detectedper 10g-
Total Aerobic Microbial Countmax. 1000CFU/gPlate count
Total Yeasts and Moulds Countmax. 100CFU/g-
Note
  • "EP" stands for European Pharmacopeia
  • "NF" stands for National Formulary from USP-NF
  • "JP" stands for Japanese Pharmacopeia
  • (*)-Compliance data - Tests not performed
  • (**)-Monitoring plan

Regulatory & Compliance

Certifications & Compliance
Chemical Inventories
Grade
Conformity
Meets the requirements of the current monograph of
  • European Pharmacopeia (EP),(1542)
  • National Formulary (NF) from USP-NF
  • Please contact us for any statement regarding compliance to the General Chapters (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent).

Technical Details & Test Data

Note
Due to a few rare reported allergic reactions with pea (and their derived products), we strongly suggest to our customers to list the botanical origin of their pea derived products in their ingredient statement.
Glass Transition Temperature vs. Water Content

Roquette KLEPTOSE Linecaps 17 Pea Maltodextrin, Pharma Glass Transition Temperature vs. Water Content

Viscosity in Water

Roquette KLEPTOSE Linecaps 17 Pea Maltodextrin, Pharma Viscosity in Water

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 334517
  • Article (SKU) Code: 334517101E
  • Package Size & Type: 25 kg PE lined pinch bottom paper bag

Storage & Handling

Storage & Shelf Life
Expiry date of the packaged product
  • manufacturing date + 5 years.
  • The product durability may very according to packaging type and manufacturing plant. Proper information is shown on labeling and CoA.
  • We recommend preserving the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity. Upon opening, use the product as quickly as possible to prevent moisture regain.