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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.
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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
Color
White
Appearance
White fine powder
Insoluble in
Methylene Chloride
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-

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.

Packaging & Availability

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Packaging Information
  • ROQ Product Code: 731801
  • Article (SKU) Code: 731801551
  • Package Size & Type: 30 kg lined cardboard box

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

Most Viewed Documents

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Document Name
Type
Products
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Glycolys® Low Solvent Sodium Starch Glycolate - Pharma Technical Data Sheet
Technical Data Sheet
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Technical Data Sheet
Products: GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Roquette Quality Certification HALAL Itapevi - EN
Other
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Other
Products: GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Roquette Quality Certification FDA Americas - EN
Other
Roquette 400L-NF Corn Starch - Pharma, GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma
Other
Products: Roquette 400L-NF Corn Starch - Pharma, GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma
Glycolys® Low Solvent Sodium Starch Glycolate - Pharma Safety Data Sheet (US - EN)
Safety Data Sheet
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
Products: GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
GLYCOLYS® Low Solvent Safety Data Sheet (REC - PT)
Safety Data Sheet
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Safety Data Sheet
Products: GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Roquette Quality Information Note BSE-TSE - EN
Other
Roquette 400L-NF Corn Starch - Pharma, GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma, XYLISORB® 300 Xylitol - Pharma
Other
Products: Roquette 400L-NF Corn Starch - Pharma, GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma, XYLISORB® 300 Xylitol - Pharma
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