Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
MANNITAB™ F1 Export Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ F1 Domestic Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ F1 Release Specification
Shows the quality standards of a material according to a list of tests required
MANNITAB™ F1 MSDS
MSDS: Material Safety Data Sheet
MANNITAB™ F1 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
MANNITAB™ F1 Source of origin
The country of origin of the excipient
MANNITAB™ F1 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
MANNITAB™ F1 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
MANNITAB™ F1 Heavy metal
Reports the detection and estimation of the Heavy Metals
MANNITAB™ F1 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
MANNITAB™ F1 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
MANNITAB™ F1 Allergen
Related to Regulation or specific allergens evaluated
MANNITAB™ F1 Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
MANNITAB™ F1 Microanalytical
Report which shows Microbial limit test results
MANNITAB™ F1 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
MANNITAB™ F1 GRAS
GRAS: Generally Recognized as Safe
MANNITAB™ F1 Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
MANNITAB™ F1 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
MANNITAB™ F1 Genotoxic
Declaration if the material is free from Genotoxic Impurities
MANNITAB™ F1 Viral microbiological
Viral safety information
MANNITAB™ F1 Melamine
Declaration that confirm if the material is free of melamine contamination
MANNITAB™ F1 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.
MANNITAB™ F1 Stability
To show that the stability meets the excipient specification
MANNITAB™ F1 Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
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