Native Starch, Corn

USP-NF, Ph. Eur., JPE

Key benefits

  • Extra-white
  • Moisture: NMT 14%
  • Promotes Disintegration
  • EIP Index available


  • Filler

Dosage form

  • Tablets Tablets
  • Hard Capsules Hard Capsules

Product documentation

This product has 25 documents

Document nameDescriptionDownload

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

PURITY® 21A Specimen CoA

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

PURITY® 21A Release Specification

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


MSDS: Material Safety Data Sheet

PURITY® 21A Label

Displays the label graphic


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

PURITY® 21A Source of origin

The country of origin of the excipient

PURITY® 21A 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)

PURITY® 21A Heavy metal

Reports the detection and estimation of the Heavy Metals

PURITY® 21A Elemental impurities

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

PURITY® 21A Nitrosamine

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

PURITY® 21A Allergen

Related to Regulation or specific allergens evaluated

PURITY® 21A Gluten-free

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

PURITY® 21A Microanalytical

Report which shows Microbial limit test results

PURITY® 21A Residual solvent

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


GRAS: Generally Recognized as Safe

PURITY® 21A Storage condition

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

PURITY® 21A Latex free

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

PURITY® 21A Genotoxic

Declaration if the material is free from Genotoxic Impurities

PURITY® 21A Viral microbiological

Viral safety information

PURITY® 21A Melamine

Declaration that confirm if the material is free of melamine contamination

PURITY® 21A 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.

PURITY® 21A Halal

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

PURITY® 21A Kosher

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