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
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 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 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 Viral microbiological
Viral safety information
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 Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
On-demand Documentation
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