Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Ingredient Name
- Ingredient Origin
- Pharma & Nutraceuticals Functions
- Technologies
Features & Benefits
- Labeling Claims
- Batch to Batch Consistency
As with many plant-based excipients, source variability could be a concern. Therefore, we manage the variability of our Refined Soybean Oil IV by closely working with source suppliers. Our 9-step purification process guarantees high quality and consistency of the final product for your formulations, from topical to intravenous applications.
Applications & Uses
- Applications
- Dosage Form
Regulatory & Compliance
- Certifications & Compliance
- Compliance with the Most Demanding Regulations
- Manufactured under cGMP according to the ICH-Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
- A 9-step purification process is applied to the starting material (crude soybean oil) to deliver a high-quality purified oil. Final steps of the process, including fine filtration and drum filling under nitrogen, are performed in an ISO 8 class cleanroom.
- Supported with Certificate of Suitability to the European Pharmacopeia (CEP) granted by the European Directorate for the Quality of Medicines & HealthCare (EDQM) certifying that the substance is suitably manufactured and controlled according to the current version of the monograph Soybean Oil, refined (1473).
- Supported with Drug Master File (DMF) type IV for excipients submitted to the U.S. Food and Drug Administration (FDA). DMF # 028 528.
Technical Details & Test Data
- Manufacturing Process Control
- Specific sourcing & control of the starting material
- Adjustment of purification process parameters
- Real-time process monitoring
- In-process control tests
- Out-of-trend monitoring
- Management of Contaminants & Natural 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
Packaging & Availability
- Packaging Type
- Packaging Information
ADM-SIO’s Refined Soybean Oil IV is available in 56.5 Kg or 200 Kg tight-head metal drums that are filled under nitrogen in an ISO 8-classified cleanroom.
Storage & Handling
- Stability
Stability studies performed according to the International Conference on Harmonization (ICH) Q1A Quality. Guideline show that Refined Soybean Oil IV is perfectly stable over a 36-month shelf life period.