UNI-PURE® GA P100

Modified Starch, Corn

USP-NF, Ph. Eur.

Description

An Excellent Multi-compendial 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
  • It is compatible with a variety of drug actives
  • EIP Index available

Functionalities

  • Film Forming
  • Gelatin Replacer

Dosage form

  • Softgel Capsule Softgel Capsule
Files

Product documentation

This product has 25 documents

Document nameDescriptionDownload
UNI-PURE® GA P100 EIP Index

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

UNI-PURE® GA P100 Specimen CoA

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

UNI-PURE® GA P100 Release Specification

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

UNI-PURE® GA P100 MSDS

MSDS: Material Safety Data Sheet

UNI-PURE® GA P100 Label

Displays the label graphic

UNI-PURE® GA P100 TSE BSE

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

UNI-PURE® GA P100 Source of origin

The country of origin of the excipient

UNI-PURE® GA P100 Regulatory Compliance

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

UNI-PURE® GA P100 Non-GMO

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

UNI-PURE® GA P100 Heavy metal

Reports the detection and estimation of the Heavy Metals

UNI-PURE® GA P100 Elemental impurities

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

UNI-PURE® GA P100 Nitrosamine

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

UNI-PURE® GA P100 Allergen

Related to Regulation or specific allergens evaluated

UNI-PURE® GA P100 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 P100 Microanalytical

Report which shows Microbial limit test results

UNI-PURE® GA P100 Residual solvent

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

UNI-PURE® GA P100 GRAS

GRAS: Generally Recognized as Safe

UNI-PURE® GA P100 Storage condition

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

UNI-PURE® GA P100 Latex free

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

UNI-PURE® GA P100 Genotoxic free

Declaration if the material is free from Genotoxic Impurities

UNI-PURE® GA P100 Viral microbiological

Viral safety information

UNI-PURE® GA P100 Melamine

Declaration that confirm if the material is free of melamine contamination

UNI-PURE® GA P100 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 P100 Stability

To show that the stability meets the excipient specification

UNI-PURE® GA P100 Halal

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