ULTRA-TEX® 4

Modified Pregel Starch

Description

Our modified starch for syrups and suspensions, ULTRA-TEX® 4, is a highly versatile solution with beneficial characteristics.

Its high performing nature, coupled with Its ability to rapidly hydrate, helping to reduce cost in manufacturing.

Moreover, its high gloss and sheen properties not only enhance the appearance of the final product but also add an element of visual appeal.

Whether facing high-shear forces or elevated temperatures, this ingredient maintains its integrity, providing instant viscosity and ensuring consistent quality in diverse manufacturing conditions.

ULTRA-TEX® 4 stands out for its versatility, making it a valuable addition to syrups and suspension formulations.

Find out ULTRA-TEX® 4 Excipient Information Package (EIP) below.

Key benefits

  • It is an excellent viscosifier for suspension of insoluble actives
  • Provides instant viscosity
  • Hydrates quickly
  • EIP Index available

Functionalities

  • Viscosifier
  • Thickener
  • Suspension aid
  • Texturizing agent

Dosage form

  • Syrups & Suspensions Syrups & Suspensions
EIP Documentation updated in Dec. 24

Product documentation

This product has 26 documents

Document name Description Download
ULTRA-TEX® 4 EIP Index

Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand

ULTRA-TEX® 4 Specimen CoA

Certifies the quality of the excipient and demonstrates the batch meets the defined specification

ULTRA-TEX® 4 Release Specification

Shows the quality standards of a material according to a list of tests required

ULTRA-TEX® 4 MSDS

MSDS: Material Safety Data Sheet

ULTRA-TEX® 4 Label

Displays the label graphic

ULTRA-TEX® 4 TSE BSE

TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)

ULTRA-TEX® 4 Source of origin

The country of origin of the excipient

ULTRA-TEX® 4 Regulatory Compliance

Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status

ULTRA-TEX® 4 Non-GMO

A declaration that the material is not derived from a Genetically Modified Organism (GMO)

ULTRA-TEX® 4 Heavy metal

Reports the detection and estimation of the Heavy Metals

ULTRA-TEX® 4 Elemental impurities

Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D

ULTRA-TEX® 4 Nitrosamine

A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material

ULTRA-TEX® 4 Allergen

Related to Regulation or specific allergens evaluated

ULTRA-TEX® 4 Gluten free

The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)

ULTRA-TEX® 4 Microanalytical

Report which shows Microbial limit test results

ULTRA-TEX® 4 Residual solvent

Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia

ULTRA-TEX® 4 GRAS

GRAS: Generally Recognized as Safe

ULTRA-TEX®4 Storage condition

The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies

ULTRA-TEX® 4 Latex free

Certifies that the material is not made with natural rubber latex, latex derivatives

ULTRA-TEX® 4 Genotoxic free

Declaration if the material is free from Genotoxic Impurities

ULTRA-TEX® 4 Country of origin

It is the country of manufacture or production

ULTRA-TEX® 4 Aflatoxins

Declaration that the material is free from Aflatoxins

ULTRA-TEX® 4 Melamine

Declaration that confirm if the material is free of melamine contamination

ULTRA-TEX® 4 Shelf-life

The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.

ULTRA-TEX® 4 Halal

Halal indicates that this product is permitted and fit for consumption according to Islamic law

ULTRA-TEX® 4 Kosher

Certifies that this ingredient and the process of preparing it complies with orthodox kosher