Native starch, Corn

USP-NF, Ph. Eur.,Ch.P


Multi-compendial and low-moisture starch suitable for moisture-sensitive actives

Key benefits

  • NMT 5% Moisture
  • Inhibits the caking of hygroscopic materials
  • Can be used as a binder in Wet Granulation (when cooked)
  • EIP Index available


  • Filler
  • Diluent
  • Bulking agent
  • Binder

Dosage form

  • Tablets Tablets
  • Hard Capsules Hard Capsules

Product documentation

This product has 26 documents

Document nameDescriptionDownload

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

UNI-PURE® F5 Specimen CoA

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

UNI-PURE® F5 Release Specification

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


MSDS: Material Safety Data Sheet

UNI-PURE® F5 Label

Displays the label graphic


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

UNI-PURE® F5 Source of origin

The country of origin of the excipient

UNI-PURE® F5 Regulatory Compliance

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


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

UNI-PURE® F5 Heavy metal

Reports the detection and estimation of the Heavy Metals

UNI-PURE® F5 Elemental impurities

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

UNI-PURE® F5 Nitrosamine

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

UNI-PURE® F5 Allergen

Related to Regulation or specific allergens evaluated

UNI-PURE® F5 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® F5 Microanalytical

Report which shows Microbial limit test results

UNI-PURE® F5 Residual solvent

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


GRAS: Generally Recognized as Safe

UNI-PURE® F5 Storage condition

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

UNI-PURE® F5 Latex free

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

UNI-PURE® F5 Genotoxic free

Declaration if the material is free from Genotoxic Impurities

UNI-PURE® F5 Viral microbiological

Viral safety information

UNI-PURE® F5 Melamine

Declaration that confirm if the material is free of melamine contamination

UNI-PURE® F5 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® F5 Stability

To show that the stability meets the excipient specification

UNI-PURE® F5 Halal

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

UNI-PURE® F5 Kosher

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