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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

Markets
Applications
Dosage Form
Manufacturing Technology
Application
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

Properties

Physical Form
Taste
Slightly sweet
Appearance
White or almost white crystalline powder
Soluble in
Water
Insoluble in
Ethanol (96%)
Typical Properties
ValueUnitsTest Method / Conditions
AcidityComplies-JP
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°
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
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

Note
  • 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.
Morphology

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