Mannitol

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

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

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

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

MSDS: Material Safety Data Sheet

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

The country of origin of the excipient

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)

Reports the detection and estimation of the Heavy Metals

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

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

Related to Regulation or specific allergens evaluated

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

Report which shows Microbial limit test results

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

GRAS: Generally Recognized as Safe

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

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

Declaration if the material is free from Genotoxic Impurities

Viral safety information

Declaration that confirm if the material is free of melamine contamination

The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.

To show that the stability meets the excipient specification

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