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NEOSORB® P 300 C Sorbitol - Pharma

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Chemical Name: D-Glucitol
Function: Binder, Filler
Certifications & Compliance: United States Pharmacopeia (USP), Canadian Environmental Protection Act (CEPA), Japan Pharmacopeia (JP), European Pharmacopeia (Ph. Eur.)
Labeling Claims: Sugar-free, Non-Carcinogenic
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TypeDocument Name
Safety Data Sheet
Neosorb® P 300 C Sorbitol - Pharma Safety Data Sheet (US - EN)
Neosorb® P 300 C Sorbitol - Pharma Safety Data Sheet (US - EN)
Safety Data Sheet
Technical Data Sheet
Neosorb® P 300 C Sorbitol - Pharma Technical Data Sheet
Neosorb® P 300 C Sorbitol - Pharma Technical Data Sheet
Technical Data Sheet

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Identification & Functionality

NEOSORB® P 300 C Sorbitol - Pharma Features & Benefits

Applications & Uses

Properties

Physical Form
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%-
pH Value3.5 - 7.0-NF
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%-
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 detectedper gramEP
Salmonella (**)Not detectedper 10gEP
Total Yeasts and Moulds Count(**)max. 100CFU/gEP / NF
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

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

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.
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Packaging & Availability

Packaging Information
  • ROQ Product Code: 423601
  • Article (SKU) Code: 423601101
  • Package Size & Type: 25 kg STRIPPABLE PAPER BAG + POLY BAG PB

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 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.
NEOSORB® P 300 C Sorbitol - Pharma
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