UNI-PURE® FN

Native Starch, Corn

USP-NF, Ph. Eur., BP

Description

Multi-compendial Native Starch can be used as a Filler and binder

Key benefits

  • NMT 12% Moisture
  • Inhibits the caking of hygroscopic materials
  • Can be used as a binder in Wet Granulation (when cooked)
  • EIP Index available

Functionalities

  • Filler
  • Diluent
  • Bulking agent
  • Binder

Dosage form

  • Tablets Tablets
  • Hard Capsules Hard Capsules
Files

Product documentation

This product has 26 documents

Document nameDescriptionDownload
UNI-PURE® FN EIP Index

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

UNI-PURE® FN Specimen CoA

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

UNI-PURE® FN Release Specification

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

UNI-PURE® FN MSDS

MSDS: Material Safety Data Sheet

UNI-PURE® FN Label

Displays the label graphic

UNI-PURE® FN TSE BSE

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

UNI-PURE® FN Source of origin

The country of origin of the excipient

UNI-PURE® FN Regulatory Compliance

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

UNI-PURE® FN Non-GMO

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

UNI-PURE® FN Heavy metal

Reports the detection and estimation of the Heavy Metals

UNI-PURE® FN Elemental impurities

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

UNI-PURE® FN Nitrosamine

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

UNI-PURE® FN Allergen

Related to Regulation or specific allergens evaluated

UNI-PURE® FN 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® FN Microanalytical

Report which shows Microbial limit test results

UNI-PURE® FN Residual solvent

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

UNI-PURE® FN GRAS

GRAS: Generally Recognized as Safe

UNI-PURE® FN Storage condition

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

UNI-PURE® FN Latex free

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

UNI-PURE® FN Genotoxic

Declaration if the material is free from Genotoxic Impurities

UNI-PURE® FN Viral microbiological

Viral safety information

UNI-PURE® FN Melamine

Declaration that confirm if the material is free of melamine contamination

UNI-PURE® FN 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® FN Stability

To show that the stability meets the excipient specification

UNI-PURE® FN Halal

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

UNI-PURE® FN Kosher

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