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