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FARMAL® SS 2515 R EIP Index
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Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand |
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FARMAL® SS 2515 R Release Specification
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Shows the quality standards of a material according to a list of tests required |
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FARMAL® SS 2515 R TSE BSE
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TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy) |
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FARMAL® SS 2515 R Source of origin
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The country of origin of the excipient |
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FARMAL® SS 2515 R Regulatory Compliance
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Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status |
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FARMAL® SS 2515 R Non-GMO
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A declaration that the material is not derived from a Genetically Modified Organism (GMO) |
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FARMAL® SS 2515 R Heavy metal
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Reports the detection and estimation of the Heavy Metals |
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FARMAL® SS 2515 R Elemental impurities
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Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D |
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FARMAL® SS 2515 R Nitrosamine
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A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material |
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FARMAL® SS 2515 R Allergen
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Related to Regulation or specific allergens evaluated |
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FARMAL® SS 2515 R Gluten free
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The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm) |
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FARMAL® SS 2515 R Microanalytical
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Report which shows Microbial limit test results |
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FARMAL® SS 2515 R Residual solvent
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Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia |
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FARMAL® SS 2515 R GRAS
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GRAS: Generally Recognized as Safe |
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FARMAL® SS 2515 R Storage condition
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The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies |
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FARMAL® SS 2515 R Latex free
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Certifies that the material is not made with natural rubber latex, latex derivatives |
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FARMAL® SS 2515 R Genotoxic
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Declaration if the material is free from Genotoxic Impurities |
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FARMAL® SS 2515 R Country of origin
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It is the country of manufacture or production |
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FARMAL® SS 2515 R Aflatoxins
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Declaration that the material is free from Aflatoxins |
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FARMAL® SS 2515 R Melamine
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Declaration that confirm if the material is free of melamine contamination |
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FARMAL® SS 2515 R Halal
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Halal indicates that this product is permitted and fit for consumption according to Islamic law |
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FARMAL® SS 2515 R Kosher Declaration
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Certifies that this ingredient and the process of preparing it complies with orthodox kosher |
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Softgel Capsule