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NEOSORB® P 300 C Sorbitol - Pharma
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NEOSORB® P 300 C Sorbitol - Pharma

NEOSORB® Sorbitol pharma provides key functional properties of a filler and filler/binder as well as a bulk sweetener. Our sorbitol range has excellent tableting properties, as well as being non-cariogenic, non-acidogenic and sugar-free. These properties make it suitable to be used in formulation addressing all type of patient population including pediatric, diabetic. It can be used in pharmaceutical and nutraceutical formulations, in different types of powder blends, premixes, granules, pellets, swallowable tablets, chewable tablets, effervescent tablets and medicated confectionary. In coating/film forming applications it is a plasticizing agent well adapted to starches.
Product Resources

Experts (2)

Knowde Enhanced TDS

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Identification & Functionality

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Features & Benefits

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Applications & Uses

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Properties

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Physical Form
Typical Properties
ValueUnitsTest Method / Conditions
AcidityComplies-JP
Amount of Related Substancemax. 3.0%-
Chlorides Contentmax. 50mg/kgJP
Conductivitymax. 20microS/cmEP
D-sorbitol on DS91.0 - 100.5%NF
D-sorbitol on DS97.0 - 102.0%EP
Glucose Contentmax. 6.3mlJP
Heavy Metals Content (*)max. 5mg/kgJP
Identification Test AComplies-EP
Identification Test A (*)Complies-NF
Identification Test BComplies-NF
Identification Test 1 (*)Complies-JP
Identification Test 2 (*)Complies-JP
Identification Test 3 (*)Complies-JP
Impurity A: D-mannitolmax. 2.0%-
Impurity B: D-iditolmax. 2.0%-
Impurity C: D-maltitolmax. 2.0%-
Loss on Drying (*)max. 2.0%JP
Particle Size (min. 15 microns)min. 92%-
Particle Size (min. 220 microns)40 - 65%-
Particle Size (min. 710 microns)max. 3%-
pH3.5 - 7.0-NF
Reducing Sugarsmax. 0.2%EP
Reducing Sugarsmax. 0.3%NF
Residue on Ignitionmax. 0.02%JP
Residue on Ignitionmax. 0.1%NF
Sugar Contentmax. 6.3mlJP
Sulfates Contentmax. 60mg/kgJP
Total Aerobic Microbial Count (**)max. 1000CFU/gEp / Nf
Water Contentmax. 1.5%EP / NF
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 1.3mg/kgJP
Assay Content (on DS)min. 97.0%JP
Nickel Content (*)Complies-JP
Nickel Content (*)max. 1mg/kgNF
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia Coli (**)Not detected in 1g-EP
Salmonella (**)Not detected in 10g-EP
Total Yeasts and Moulds Count(**)max. 100CFU/gEP / NF
Appearance
White or almost white crystalline powder
Soluble in
Water
Insoluble in
Ethanol (96%)
Note
  • "EP" stands for European Pharmacopoeia
  • "NF" stands for National Formulary from USP-NF
  • "JP" stands for Japanese Pharmacopoeia
  • (*)-Compliance data - Tests not performed
  • (**)-Monitoring plan

Regulatory & Compliance

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Conformity
Conforms to the requirements of the current monograph
  • European Pharmacopoeia SORBITOL (0435)
  • National Formulary from USP-NF SORBITOL
  • Japanese Pharmacopoeia D-SORBITOL
  • 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

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Note
  • Not intended for use in manufacture of parenteral dosage forms.
  • Methods used by Roquette may be the Pharmacopoeia methods or alternative validated methods which have been compared to the Pharmacopoeia methods.
Innovation Hub
Innovation Hub by Roquette
Looking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.

Storage & Handling

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Storage & Shelf Life
  • Expiry Date Manufacturing date + 5 years, in its unopened packaging.
  • Those date is indicative and may vary according to packaging type and manufacturing plant. Proper information is shown on labelling and CoA.
  • We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity.
  • To minimise the problem of product-lumping, it is highly recommended to avoid the stacking of pallets.

Documents (2)

Document Name
Type
Products
Technical Data Sheet
NEOSORB® P 300 C Sorbitol - Pharma
Technical Data Sheet
Products: NEOSORB® P 300 C Sorbitol - Pharma
Safety Data Sheet
NEOSORB® P 300 C Sorbitol - Pharma
Safety Data Sheet
Products: NEOSORB® P 300 C Sorbitol - Pharma