Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 50-70-4
- EC No.
- 200-061-5
- Technologies
- Product Families
Features & Benefits
- Labeling Claims
Applications & Uses
Properties
- Physical Form
- Appearance
- White or almost white crystalline powder
- Soluble in
- Water
- Insoluble in
- Ethanol (96%)
- Typical Properties
Value Units Test Method / Conditions Acidity Complies - JP Amount of Related Substance max. 3.0 % - pH Value 3.5 - 7.0 - NF Chlorides Content max. 50 mg/kg JP Conductivity max. 20 microS/cm EP D-sorbitol on DS 91.0 - 100.5 % NF D-sorbitol on DS 97.0 - 102.0 % EP Glucose Content max. 6.3 ml JP Heavy Metals Content (*) max. 5 mg/kg JP Identification Test A Complies - EP Identification Test A (*) Complies - NF Identification Test B Complies - NF Identification Test 1 (*) Complies - JP Identification Test 2 (*) Complies - JP Identification Test 3 (*) Complies - JP Impurity A: D-mannitol max. 2.0 % - Impurity B: D-iditol max. 2.0 % - Impurity C: D-maltitol max. 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 Sugars max. 0.2 % EP Reducing Sugars max. 0.3 % NF Residue on Ignition max. 0.02 % JP Residue on Ignition max. 0.1 % NF Sugar Content max. 6.3 ml JP Sulfates Content max. 60 mg/kg JP Total Aerobic Microbial Count (**) max. 1000 CFU/g Ep / Nf Water Content max. 1.5 % EP / NF - Physico-Chemical Properties
Value Units Test Method / Conditions Arsenic Content max. 1.3 mg/kg JP Assay Content (on DS) min. 97.0 % JP Nickel Content (*) Complies - JP Nickel Content (*) max. 1 mg/kg NF - Microbiological Values
Value Units Test Method / Conditions Escherichia coli (**) Not detected per gram EP Salmonella (**) Not detected per 10g EP Total Yeasts and Moulds Count(**) max. 100 CFU/g EP / NF - 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.
- Innovation Hub
- Innovation Hub by RoquetteLooking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.
Packaging & Availability
- Packaging Information
- Article (SKU) Code: 5100002891
- Package Size & Type: 25 KG BAG
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.
- To minimize the problem of product-lumping, it is highly recommended to avoid the stacking of pallets.