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LYCATAB® PGS Pregelatinized Starch - Pharma

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

Brand: LYCATAB (2 products)

Chemical Name: Starch, Pregelatinized

CAS Number: 9005-25-8

Dosage Form: Granules, Pellets, Powder & Powder Blends, Sachets, Stick, Tablets

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

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

Manufacturing Technology: Wet Granulation

Technical Data Sheet Safety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

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,
Pellets,
Powder & Powder Blends,
Sachets,
Stick,
Tablets
Manufacturing Technology: Wet Granulation

Properties

Physical Form

Odor

Odorless

Appearance

White or yellowish-White powder

Typical Properties


	Value	Units	Test Method / Conditions
Iron Content (Monitoring plan)	max. 20	ppm	EP-USP/ NF
Loss on Drying	max. 14.0	%	USP / NF
Loss on Drying	max. 15.0	%	EP
Particle Size (Residue on 315 micron)	max. 20	%	-
Particle Size (Residue on 80 micron)	min. 50	%	-
pH	4.5 - 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. 80	ppm	USP / NF
Sulfur Dioxide Content (Monitoring plan)	max. 50	ppm	EP

Microbiological Values


	Value	Units	Test Method / Conditions
Escherichia coli (Monitoring plan)	Absent	per 10g	-
Salmonella Species (Monitoring plan)	Absent	per 10g	-
Total Aerobic Microbial Count	max. 1000	CFU/g	Plate count
Total Yeasts and Moulds Count	max. 100	CFU/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
Quality Standards: ICH Q7

Technical Details & Test Data

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

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.