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
PURITY® 21A MSDS
MSDS: Material Safety Data Sheet
PURITY® 21A Label
Displays the label graphic
PURITY® 21A TSE BSE
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
PURITY® 21A Non-GMO
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
PURITY® 21A GRAS
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 Country of origin
It is the country of manufacture or production
PURITY® 21A Aflatoxins
Declaration that the material is free from Aflatoxins
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
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