GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma

1 of 5 products in this brand
GLYCOLYS® Low Solvent Sodium Starch Glycolate is a superdisintegrant for pharmaceutical and nutraceutical swallowable tablets, orally dispersible tablets and hard capsules. Features Different grades designed to meet specific needs: Withstanding high shear granulation Acidic conditions Low organic solvent content

Chemical Name: Sodium Carboxymethyl Starch

Functions: Disintegrant

Certifications & Compliance: Canadian Environmental Protection Act (CEPA), European Pharmacopeia (Ph. Eur.), FDA IID, FSSAI, FSSC 22000, Halal, ISO 9001, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), United States Pharmacopeia (USP)

Labeling Claims: BSE-free, Halal, Kosher, TSE-free, Vegan

Synonyms: Carboxymethyl starch sodium salt, Sodium starch glycolate

Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
CAS No.
9063-38-1
EC No.
618-597-7

Features & Benefits

Benefits of Superdisintegrants

Our superdisintegrant offerings meet the requirements necessary to achieve fast and robust disintegration with minimal amount of disintegrating agent. These properties facilitate the use of any ingredient you need in order to optimize other parameters of your formulation (compactability or drug solubility for example).

GLYCOLYS®, one of our sodium starch glycolate (SSG)-based products, offers solutions to specific environments and conditions susceptible to affect disintegrant performance as well as ensuring stability for drugs, like GLYCOLYS® Low pH ensures stability to acidic molecules.

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Applications & Uses

Manufacturing Technology
Use Level
2 - 8%

Properties

Physical Form
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. 6%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
Water Contentmax. 10%
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliNot Detectedper gram
Pseudomonas aeruginosaNot detectedper gram
SalmonellaNot Detectedper 10g
Staphylococcus aureusNot detectedper gram
Total Aerobic Microbial Countmax. 100CFU/g
Total Yeasts and Moulds Countmax. 10CFU/g

Regulatory & Compliance

Conformity

Complies with the current USP/NF,EP and JP monographs requirements

Technical Details & Test Data

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Packaging & Availability

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

Storage & Handling

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