Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
UNI-PURE® GA P100 Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
UNI-PURE® GA P100 Release Specification
Shows the quality standards of a material according to a list of tests required
UNI-PURE® GA P100 MSDS
MSDS: Material Safety Data Sheet
UNI-PURE® GA P100 Label
Displays the label graphic
UNI-PURE® GA P100 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
UNI-PURE® GA P100 Source of origin
The country of origin of the excipient
UNI-PURE® GA P100 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
UNI-PURE® GA P100 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
UNI-PURE® GA P100 Heavy metal
Reports the detection and estimation of the Heavy Metals
UNI-PURE® GA P100 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
UNI-PURE® GA P100 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
UNI-PURE® GA P100 Allergen
Related to Regulation or specific allergens evaluated
UNI-PURE® GA P100 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® GA P100 Microanalytical
Report which shows Microbial limit test results
UNI-PURE® GA P100 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
UNI-PURE® GA P100 GRAS
GRAS: Generally Recognized as Safe
UNI-PURE® GA P100 Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
UNI-PURE® GA P100 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
UNI-PURE® GA P100 Genotoxic free
Declaration if the material is free from Genotoxic Impurities
UNI-PURE® GA P100 Viral microbiological
Viral safety information
UNI-PURE® GA P100 Melamine
Declaration that confirm if the material is free of melamine contamination
UNI-PURE® GA P100 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® GA P100 Stability
To show that the stability meets the excipient specification
UNI-PURE® GA P100 Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
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Softgel Capsule