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