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GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
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GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma

GLYCOLYS® Sodium starch glycolate provides pharmaceutical and nutraceutical manufacturers with a range of superdisintegrants for different formulation needs. Our GLYCOLYS® product provides this benefit for swallowable tablets, orally dispersible tablets and hard capsules. Roquette has been producing sodium starch glycolate for more than 20 years. We have developed different grades of GLYCOLYS® to meet specific needs, such as withstanding high shear granulation, acidic conditions or with a low organic solvent content.
Product Resources

Experts (2)

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Identification & Functionality

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Features & Benefits

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Applications & Uses

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Properties

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Physical Form
Typical Properties
ValueUnitsTest Method / Conditions
Combined Sodium Content2.8 - 4.2%Ph.Eur.-USP-JP
Ethanol Contentmax. 0.50%Ph.Eur.-USP
Heavy Metals Contentmax. 20mg/kgJP
Iron Contentmax. 20mg/kgPh.Eur.-USP-JP
Loss on Dryingmax. 10%Ph.Eur.-USP-JP
Particle Size (Retained on 200 mesh. 75 microns)max. 10.0%-
pHmax. 10.0--
Sodium Chloride Contentmax. 7.0%Ph.Eur.-USP-JP
Sodium Glycolatemax. 2.0%Ph.Eur.-USP-JP
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia ColiNot detected in 1g--
Escherichia ColiNot Detected1g-
Pseudomonas AeruginosaNot detected in 1g--
Pseudomonas AeruginosaNot Detected1g-
Salmonella SpeciesNot detected in 10g--
SalmonellaNot Detected10g-
Staphylococcus AureausNot detected in 1g--
Total Aerobic Microbial Countmax. 100CFU/g-
Total Yeasts and Moulds Countmax. 10CFU/g-
Color
White
Physical Form
Powder
Appearance
White fine powder
Insoluble in
Methylene Chloride

Regulatory & Compliance

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Technical Details & Test Data

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Innovation Hub
Innovation Hub by Roquette
Looking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.

Storage & Handling

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Shelf Life
5 Years
Storage and Handling

Storage in well-closed containers preferably protected from wide variations in temperature and humidity, which may cause caking

Documents (13)

Document Name
Type
Products
Technical Data Sheet
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Technical Data Sheet
Products: GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
Products: GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
Products: GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
Products: GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
Products: GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma