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LYCATAB® PGS Pregelatinized Starch - Pharma

1 of 3 products in this brand
LYCATAB® PGS is used in pharmaceutical and nutraceutical applications as a binder for wet granulation. Features Natural pregelatinized maize starch resulting from a combination of the natural binding properties of pregels starches and a controlled manufacturing process Dispersible and partially soluble in cold water and ready for use High-stability reproducible binding properties during granulation and dissolution profile of actives in final forms Can be used in granules and swallowable forms

Chemical Name: Starch, Pregelatinized

Functions: Binder, Disintegrant, Filler

Certifications & Compliance: Chinese Pharmacopeia (ChP), EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA IID, FSSAI, FSSC 22000, GMP, Halal, ISO 9001, Kosher, United States Pharmacopeia (USP)

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

Technical Data SheetSafety Data Sheet

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Identification & Functionality

Chemical Name

Starch, Pregelatinized

Pharma & Nutraceuticals Functions

Binder,

Disintegrant,

Filler

CAS No.
9005-25-8
EC No.
232-679-6
Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants,

Fillers & Diluents

Features & Benefits

Labeling Claims

Acrylamide-free,

BSE-free,

Halal,

Kosher,

Melamine-free,

Non-GMO,

Peroxide-free,

TSE-free,

Vegan

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Granules,

Tablets

Manufacturing Technology

Wet Granulation

Properties

Physical Form

Powder,

Solid

Odor
Odorless
Appearance
White or yellowish-White powder
Typical Properties
ValueUnitsTest Method / Conditions
Iron Content (Monitoring plan)max. 20ppmEP-USP/ NF
Loss on Dryingmax. 14.0%USP / NF
Loss on Dryingmax. 15.0%EP
Particle Size (Residue on 315 micron)max. 20%—
Particle Size (Residue on 80 micron)min. 50%—
pH4.5 - 7.0—EP-USP/ NF
Residue On Ignition (Monitoring plan)max. 0.5%USP / NF
Sulfated Ash Content (Monitoring plan)max. 0.6%EP
Sulfur Dioxide Content (Monitoring plan)max. 80ppmUSP / NF
Sulfur Dioxide Content (Monitoring plan)max. 50ppmEP
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli (Monitoring plan)Absentper 10g—
Salmonella Species (Monitoring plan)Absentper 10g—
Total Aerobic Microbial Countmax. 1000CFU/gPlate count
Total Yeasts and Moulds Countmax. 100CFU/g—

Regulatory & Compliance

Certifications & Compliance

Chinese Pharmacopeia (ChP),

EXCiPACT,

European Pharmacopeia (Ph. Eur.),

FDA IID,

FSSAI,

FSSC 22000,

GMP,

Halal,

ISO 9001,

Kosher,

United States Pharmacopeia (USP)

Grade

Pharma Grade

Technical Details & Test Data

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 652106
  • Article (SKU) Code: 652106107
  • Package Size & Type: 20 kg free film paper bag

Storage & Handling

Shelf Life
5 Years
Storage and Handling

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.