Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Family
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 9063-38-1
- EC No.
- 618-597-7
- Technologies
- Product Families
- Chemical Structure
Features & Benefits
- Benefit Claims
- Labeling Claims
Applications & Uses
- Markets
- Applications
- Dosage Form
- Application
- GLYCOLYS® sodium starch glycolate is a superdisintegrant for swallowable tablets, orally dispersible tablets and hard capsules. The usual concentration employed is between 2% and 8%
Properties
- Physical Form
- Appearance
- White or almost white fine very hygroscopic powder
- Insoluble in
- Ethanol, Ether
- Dispersible in
- Water to form a viscous colloidal solution
- Typical Properties
Value Units Test Method / Conditions Acidity or Alkalinity (pH) 5.5 - 7.5 - - Average Mean Particle Diameter 45 µm - Brookfield Viscosity max. 75 mPas - Combined Sodium 2.8 - 4.2 % - Ethanol Content max. 6.0 % - Heavy Metals Content (*) max. 0.002 % - Identification Test 1 (*) Complies - ChP Identification Test 2 (*) Complies - ChP Particle Size (sieve, Residue on 105 Microns) max. 2.0 % - Sodium Chloride (on DS) max. 6.0 % - Sodium Glycolate Content max. 2.0 % - Water Content (LOD) 6 - 10 % - - Physico-Chemical Properties
Value Units Test Method / Conditions Assay Content 2.0 - 4.0 % - Iron Content (*) max. 0.002 % - Loss on Drying max. 10.0 % - - Microbiological Values
Value Units Test Method / Conditions Escherichia coli (**) Not detected per gram - Salmonella (**) Not detected per 10g - Total Aerobic Microbial Count max. 1000 CFU/g Plate count Total Yeasts and Moulds Count max. 100 CFU/g - - Note
- "ChP" stands for Chinese Pharmacopeia
- (*)-Compliance data - Tests not performed
- (**)-Monitoring plan
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
- Quality Standards
- Conformity
- Conforms to the requirements of the current monograph
- Chinese Pharmacopeia (ChP) SODIUM STARCH GLYCOLATE 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
- Morphology
- 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.
- Water Sorption Isotherm at 20°C
- Innovation Hub
- Innovation Hub by RoquetteLooking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.
Packaging & Availability
- Packaging Information
- ROQ Product Code: 731112
- Article (SKU) Code: 731112102H
- Package Size & Type: 50 kg lined fiber drum
Storage & Handling
- Storage & Shelf Life
- Expiry date Manufacturing date + 5 years, in its unopened packaging.
- The product durability 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.