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GLYCOLYS® Sodium Starch Glycolate - Pharma

GLYCOLYS® Sodium Starch Glycolate is a superdisintegrant for pharmaceutical applicationbs such as swallowable tablets, orally dispersible tablets and hard capsules. Benefits BSE-free Halal and Kosher certified Melamine-free Non-GMO Non-hazardous TSE-free Vegan Features Free of off-odors Low ethanol content

Brand: GLYCOLYS (5 products)

Chemical Name: Sodium Carboxymethyl Starch

Functions: Disintegrant

Certifications & Compliance: Chinese Pharmacopeia (ChP), EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Halal, ISO 50001, ISO 9001, Japan Pharmacopeia (JP), Kosher, United States Pharmacopeia (USP)

Labeling Claims: BSE-free, Halal, Kosher, Melamine-free, Non-GMO, Non-Hazardous, TSE-free, Vegan

Synonyms: Carboxymethyl starch sodium salt, Sodium starch glycolate

Enhanced TDS

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

Roquette GLYCOLYS Sodium Starch Glycolate - Pharma Chemical Structure

Features & Benefits

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
ValueUnitsTest Method / Conditions
Acidity or Alkalinity (pH)5.5 - 7.5--
Average Mean Particle Diameter45µm-
Brookfield Viscositymax. 75mPas-
Combined Sodium2.8 - 4.2%-
Ethanol Contentmax. 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 Contentmax. 2.0%-
Water Content (LOD)6 - 10%-
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Assay Content2.0 - 4.0%-
Iron Content (*)max. 0.002%-
Loss on Dryingmax. 10.0%-
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli (**)Not detectedper gram-
Salmonella (**)Not detectedper 10g-
Total Aerobic Microbial Countmax. 1000CFU/gPlate count
Total Yeasts and Moulds Countmax. 100CFU/g-
Note
  • "ChP" stands for Chinese Pharmacopeia
  • (*)-Compliance data - Tests not performed
  • (**)-Monitoring plan

Regulatory & Compliance

Certifications & Compliance
Chemical Inventories
Grade
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

Roquette GLYCOLYS Sodium Starch Glycolate - Pharma 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

Roquette GLYCOLYS Sodium Starch Glycolate - Pharma Water Sorption Isotherm at 20°C

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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.