Refi ned Olive Oil IV...Refi ned Olive Oil IV Description Our Refi ned Olive Oil IV is a highly...
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Refined Olive Oil IV Description Our Refined Olive Oil IV is a highly purified olive oil intended for use in the manufacture of pharmaceutical products. It fully complies with general requirements of: · European Pharmacopoeia · US Pharmacopeia Application areas Refined Olive Oil IV can be used in human and veterinary applications as: · an active pharmaceutical ingredient, notably in parenteral nutrition (e.g. large volume lipid emulsion) · an excipient, particularly for the formulation of poorly soluble drugs Possible dosage forms: ∙ injectable ∙ oral ∙ topical Regulatory environment · Manufactured under c-GMP according to the ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. · Supported with CEP (certificate of suitability to the European Pharmacopoeia) granted by the EDQM (European Directorate for the Quality of Medicines & HealthCare) certifying that the substance is suitably controlled according to the current version of the monograph Olive Oil, refined <1456> · Supported with DMF (Drug Master File) type IV for excipients submitted to the US FDA (Food and Drug Administration)
Transcript of Refi ned Olive Oil IV...Refi ned Olive Oil IV Description Our Refi ned Olive Oil IV is a highly...
Refi ned Olive Oil IV
Description Our Refi ned Olive Oil IV is a highly purifi ed olive oil intended for use in the manufacture of pharmaceutical products. It fully complies with general requirements of:
· European Pharmacopoeia · US Pharmacopeia
Application areasRefi ned Olive Oil IV can be used in human and veterinary applications as:
· an active pharmaceutical ingredient, notably in parenteral nutrition (e.g. large volume lipid emulsion)
· an excipient, particularly for the formulation of poorly soluble drugs
Possible dosage forms:
∙ injectable ∙ oral ∙ topical
Regulatory environment · Manufactured under c-GMP according to the ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
· Supported with CEP (certi� cate of suitability to the European Pharmacopoeia) granted by the EDQM (European Directorate for the Quality of Medicines & HealthCare) certifying that the substance is suitably controlled according to the current version of the monograph Olive Oil, re� ned <1456>
· Supported with DMF (Drug Master File) type IV for excipients submitted to the US FDA (Food and Drug Administration)
Manufacturing process Control · Speci� c sourcing and control of the starting material · Adjustment of puri� cation process parameters · Real-time process monitoring · In-process control tests · « Out of trends » monitoring
The perfect control of our refi ning process enables to guarantee the best batch to batch consistency.
Stability studies performed according to the International Conference on Harmonization quality guideline ICH Q1A show that Refi ned Olive Oil IV is perfectly stable over a 36-month shelf life period.
PackagingRefi ned Olive Oil IV is available in 60L or 225L tight head metal drums.
High level expertise in quality, analytics and regulation
· Quality procedures system & management · Personnel training · Validated manufacturing process · Compendial analytical procedures · Control of critical steps and risk assessments · Regulatory support for fi le submission
Contaminants / Impurities
· Control of bacterial endotoxins
· Elemental impurities according to ICH Q3D
· Residual solvents: compliance with ICH Q3C and EP 5.4 requirements
· Absence of TSE/BSE risk
· Absence of mycotoxins and genotoxic impurities risk
To fi nd out how we can help you create innovative products, contact us today:
ADM - SIO2 Rue George Sand - Bat A78112 [email protected]+ 33 (0)1 74 08 03 00 + 33 (0)1 39 21 01 40www.admsio.com
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