UNI-PURE® GA

Modified starch, Corn

Description

Excellent film former for gelatin-free softgel capsules. It is designed to work with other hydrocolloids

Key benefits

  • Good film formation and gel strength
  • Provides clear film, stability, protection, and efficient release for your Veggie Softgels formulations
  • This Non-GMO gelatin replacement is compatible with a variety of actives
  • EIP Index available

Functionalities

  • Film Forming
  • Gelatin Replacer

Dosage form

  • Softgel Capsule Softgel Capsule
EIP Documentation updated in Dec. 24

Product documentation

This product has 27 documents

Document name Description Download
UNI-PURE® GA EIP Index

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

UNI-PURE® GA Specimen CoA

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

UNI-PURE® GA Release Specification

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

UNI-PURE® GA MSDS

MSDS: Material Safety Data Sheet

UNI-PURE® GA Label

Displays the label graphic

UNI-PURE® GA TSE BSE

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

UNI-PURE® GA Source of origin

The country of origin of the excipient

UNI-PURE® GA Regulatory Compliance

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

UNI-PURE® GA Non-GMO

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

UNI-PURE® GA Heavy metal

Reports the detection and estimation of the Heavy Metals

UNI-PURE® GA Elemental impurities

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

UNI-PURE® GA Nitrosamine

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

UNI-PURE® GA Allergen

Related to Regulation or specific allergens evaluated

UNI-PURE® GA Gluten free

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

UNI-PURE® GA Microanalytical

Report which shows Microbial limit test results

UNI-PURE® GA Residual solvent

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

UNI-PURE® GA GRAS

GRAS: Generally Recognized as Safe

UNI-PURE® GA Storage condition

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

UNI-PURE® GA Latex free

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

UNI-PURE® GA Genotoxic free

Declaration if the material is free from Genotoxic Impurities

UNI-PURE® GA Country of origin

It is the country of manufacture or production

UNI-PURE® GA Aflatoxins

Declaration that the material is free from Aflatoxins

UNI-PURE®GA Melamine

Declaration that confirm if the material is free of melamine contamination

UNI-PURE® GA 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.

UNI-PURE® GA Stability

To show that the stability meets the excipient specification

UNI-PURE® GA Kosher

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

UNI-PURE® GA Halal

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