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Roquette DEXTROSE MONOHYDRATE F
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Roquette DEXTROSE MONOHYDRATE F

Producer:  Roquette
Dextrose monohydrate provides key excipient and nutrient benefits as a filler/binder and a carbohydrate source. Glucose or dextrose is the monomer of natural starch polymer. This monomer is also the natural physiological sugar in the human body. In its crystalline form this natural sugar has long been used both as a filler for oral dosage forms and as a sweetener. Roquette has a range of dextrose products wide enough to meet any of manufacturers' different requirements. Our offering includes various particle sizes, and a specifc grade for compression.Dextrose monohydrate can provide benefit to swallowable tablets, chewable tablets, effervescent tablets and medicated confectionaries. As an excipient it can be used as a filler/binder. As a nutrient it is a carbohydrate source.
Product Resources

Experts (2)

Knowde Enhanced TDS

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Identification & Functionality

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Features & Benefits

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Product Highlights

DEXTROSE MONOHYDRATE F is Purified and crystallized D-glucose, containing one molecule of water of crystallization.

Applications & Uses

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Properties

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Physical Form
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 1mg/kg-
Chlorides Contentmax. 180mg/kg-
Lead Contentmax. 0.1mg/kg-
Specific Rotation+ 52.6° to + 53.2°Degree-
Loss on Dryingmax. 9.1%-
Particle Size (sieve, Residue on 100 microns)min. 10%-
Particle Size (sieve, Residue on 250 microns)max. 25%-
Particle Size (sieve, Residue on 315 microns)max. 7%-
Reducing Sugars99.5 - 100.5%-
Starch ContentComplies--
Sulfur Dioxide Contentmax. 10mg/kg-
Sulphated Ash Contentmax.0.1%-
Total Solids Contentmin. 90.0%-
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia ColiNot detected in 10g--
SalmonellaNot detected in 25g--
Total Aerobic Microbial Countmax. 1000CFU/g-
Total Moulds Microbial Countmax. 10CFU/g-
Total Yeasts Microbial Countmax. 10CFU/g-
Color
White
Appearance
Crystalline powder
Taste
Sweet
Odor
Odourless

Regulatory & Compliance

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Conformity

Meets the requirements of the current monograph of

  • Food Chemical Codex, DEXTROSE
  • CODEX STAN 212 - 1999, Standard for sugars

 

Complies with

  • US code of Federal Regulations 21 CFR § 168.111 - DEXTROSE MONOHYDRATE
  • Council Directive (EC) No. 2001/111 related to certain sugars intended for human consumption and these amendments.

Technical Details & Test Data

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Note

Due to its fine particle size, this product is liable to become compacted.

Storage & Handling

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Storage & Shelf Life

Minimum durability date of the packaged product
manufacturing date + 12 months.

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 labelling 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.

Documents (2)

Document Name
Type
Products
Technical Data Sheet
Roquette DEXTROSE MONOHYDRATE F
Technical Data Sheet
Products: Roquette DEXTROSE MONOHYDRATE F
Safety Data Sheet
Roquette DEXTROSE MONOHYDRATE F
Safety Data Sheet
Products: Roquette DEXTROSE MONOHYDRATE F