HI-CAP® 100

Modified Starch, Corn

Description

Well suited for encapsulation of vitamins at high oil loading. Non-GMO

Key benefits

  • Excellent resistance to oxidation
  • The compatibility with fats and oils permits the preparation of spray-dried powders with a higher level of active loading
  • The excellent film-forming ability reduces the loss of volatile active ingredients during spray drying and storage

Functionalities

  • Encapsulant
  • Emulsifying agent

Dosage form

  • Encapsulated powder Encapsulated powder
Files

Product documentation

This product has 26 documents

Document name Description Download
HI-CAP®100 EIP Index

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

HI-CAP® 100 Specimen CoA

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

HI-CAP® 100 Release Specification

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

HI-CAP®100 MSDS

MSDS: Material Safety Data Sheet

HI-CAP®100 Label

Displays the label graphic

HI-CAP®100 TSE BSE

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

HI-CAP® 100 Source of origin

The country of origin of the excipient

HI-CAP®100 Regulatory Compliance

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

HI-CAP®100 Non-GMO

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

HI-CAP®100 Heavy metal

Reports the detection and estimation of the Heavy Metals

HI-CAP®100 Elemental impurities

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

HI-CAP®100 Nitrosamine

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

HI-CAP®100 Allergen

Related to Regulation or specific allergens evaluated

HI-CAP®100 Gluten free

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

HI-CAP®100 Microanalytical

Report which shows Microbial limit test results

HI-CAP®100 Residual solvent

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

HI-CAP®100 GRAS

GRAS: Generally Recognized as Safe

HI-CAP®100 Storage condition

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

HI-CAP®100 Latex free

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

HI-CAP®100 Genotoxic free

Declaration if the material is free from Genotoxic Impurities

HI-CAP®100 Country of origin

It is the country of manufacture or production

HI-CAP®100 Aflatoxins

Declaration that the material is free from Aflatoxins

HI-CAP® 100 Melamine

Declaration that confirm if the material is free of melamine contamination

HI-CAP® 100 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.

HI-CAP® 100 Halal

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

HI-CAP® 100 Kosher

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