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NEOSORB® P 300 SD Sorbitol - Pharma

NEOSORB® XTAB 300S is a directly compressible sorbitol powder that can be used for very hard, sugar-free tablets with high flavor load. Benefits Delivers a smooth, hard and uniform colored surface Provides a clean, cooling effect Does not produce acids or cause dental plaque or tooth decay Nutritional benefits (maintenance of tooth mineralization, tooth-friendly generic EU claims) recognized by European regulations Features Non-cariogenic Sugar-free

Brand: NEOSORB® P (4 products)

Chemical Name: D-Glucitol

Functions: Binder, Filler, Plasticizer, Sweetener

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), United States Pharmacopeia (USP)

Labeling Claims: Non-Carcinogenic, Non-Hazardous, Sugar-free

Synonyms: D-Sorbitol, D-Sorbol, Diakarmon, G-ol, Glc-ol, Glucarine, Karion, Multitol, Sionit, Sionite, Sorbilande

Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Applications & Uses

Dosage Form
Manufacturing Technology
NEOSORB® P 300 SD sorbitol is a direct compression excipient. It is a non-cariogenic and non-acidogenic sugar-free sweetener that is suitable for chewable, suckable or effervescent tablets


Physical Form
Slightly sweet
White or almost white crystalline powder
Soluble in
Insoluble in
Ethanol (96%)
Typical Properties
ValueUnitsTest Method / Conditions
Amount of Related Substancemax. 3.0%EP
pH Value3.5 - 7.0-NF
Average Mean Particle Diameter300µm-
Chlorides Contentmax. 50mg/kgJP
Conductivitymax. 20microS/cmEP
Dsorbitol on DS91.0 - 100.5%NF
Dsorbitol on DS97.0 - 102.0%EP
Glucose Contentmax. 6.3mlJP
Heavy Metals Content (*)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%EP
Impurity B: D-iditolmax. 2.0%EP
Impurity C: D-maltitolmax. 2.0%EP
Loss on Drying (*)max. 2.0%JP
Melting Temperature95 - 98°C-
Molecular Weight182.17g/mol-
Particle Size Distribution by Laser Diffraction (dv10)156µm-
Particle Size Distribution by Laser Diffraction (dv50)304µm-
Particle Size Distribution by Laser Diffraction (dv90)530µm-
Reducing Sugarsmax. 0.2%EP
Reducing Sugarsmax. 0.3%NF
Residue on 100 micronsmin. 95%-
Residue on 500 micronsmax. 5%-
Residue on Ignitionmax. 0.02%JP
Residue on Ignitionmax. 0.1%NF
Sugar Contentmax. 6.3mlJP
Sulfates Contentmax. 60mg/kgJP
Water Contentmax. 1.5%EP / NF
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 1.3%JP
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 detectedper gramEP
Salmonella (**)Not detectedper 10gEP
Total Aerobic Microbial Count (**)max. 1000CFU/gEp / Nf
Total Yeasts and Moulds Count(**)max. 100CFU/gEP / NF
Powder Characteristics
ValueUnitsTest Method / Conditions
Powder Flowability7Saccording to Ph.Eur. 2.9.16, 10mm outflow opening
Bulk Density 0.53g/cm³
Tapped Density0.57g/cm3
True Density1.507g/cm3
Specific Surface Area2.1m²/g
Angle of Repose43°
  • "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
Conforms to the requirements of the current monograph
  • European Pharmacopeia SORBITOL (0435)
  • National Formulary from USP-NF SORBITOL
  • Japanese Pharmacopeia 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

  • Not intended for use in manufacture of parenteral dosage forms.
  • Methods used by Roquette may be the Pharmacopeia methods or alternative validated methods which have been compared to the Pharmacopeia methods.

Roquette NEOSORB P 300 SD Sorbitol - Pharma Morphology

Experimental Conditions for Compression Behavior
Tablet Press STYLCAM 200R 
Production Speed  25 tablets/min (linear punch velocity: 96 mm/s; simulated rotary press speed: approximately 150000 tablets/hour) 
Tooling  Diameter 10 mm R9 Concave 
Lubrication  0.5% magnesium stearate 
Tablet Mass 400 mg 


Water Sorption Isotherm at 20°C

Roquette NEOSORB P 300 SD Sorbitol - Pharma Water Sorption Isotherm at 20°C

Compression Behaviour

Roquette NEOSORB P 300 SD Sorbitol - Pharma Compression Behavior

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 423221
  • Article (SKU) Code: 423221101
  • Package Size & Type: 15 kg PE lined cardboard box

Storage & Handling

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 labeling and CoA.
  • We recommend to preserve 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