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