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LYCATAB® C Partially Pregelatinized Starch - Pharma

1 of 3 products in this brand
LYCATAB® C partially pregelatinized starch is used in pharmaceutical and nutraceutical applications as a multifunctional for oral dosage forms. Applications gelatin capsules as a filler direct compression applications as a filler/binder swallowable tablets and hard capsules as a filler/binder/disintegrant Features Combines the disintegration power of starch granules with the high cohesion and good compressibility of pregelatinized starch Due to limited flow properties, often requires the use of additional excipients and production steps such as granulation or partial pregelatinization

Chemical Name: Starch, Pregelatinized

Functions: Binder, Disintegrant, Filler

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

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

TSE-free,

Vegan

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Capsules,

Tablets

Manufacturing Technology

Direct Compression

Properties

Physical Form

Powder,

Solid

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 200 micron)max. 7%—
Particle Size (Residue on 80 micron)min. 40%—
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),

European Pharmacopeia (Ph. Eur.),

FSSAI,

FSSC 22000,

GMP,

Halal,

ISO 9001,

Japan Pharmacopeia (JP),

Kosher,

United States Pharmacopeia (USP)

Grade

Pharma Grade

Conformity

Conforms to the requirements of the current monograph 

  • Chinese Pharmacopeia (ChP) Pregelatinized Starch

Technical Details & Test Data

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 652105
  • Article (SKU) Code: 652105102
  • Package Size & Type: 25 kg free film paper bag

Storage & Handling

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.