Precision in Every Drop: The Potential of Refined Soybean Oil in Lipophilic Drugs
![ADM SIO Refined Soybean Oil](https://www.pharmaexcipients.com/wp-content/uploads/2024/03/ADM-SIO-Refined-Soybean-Oil.jpg)
ADM´s Refined Soybean Oil IV is a highly purified soybean oil fully compliant with the:
“European Pharmacopoeia (1473) and United States Pharmacopeia/National Formulary (USP/ NF) monographs and general notices”
intended for use in the manufacturing of pharmaceutical products.
Unmatched Quality for Use as API or Excipient in Formulation of Lipophilic Drugs
Refined Sesame Oil IV-1 can be used in Human and Veterinary Applications such as:
![ADM SIO Refined Soybean Oil](https://www.pharmaexcipients.com/wp-content/uploads/2024/03/Unmatched-Quality-for-Use-as-API-or-Excipient-in-1024x120.jpg)
Active Pharmaceutical Ingredient (API), in parenteral nutrition (e.g. large volume lipid emulsion)
Excipient, for the formulation of poorly soluble drugs
![ADM REFINED SOYBEAN OIL IV](https://www.pharmaexcipients.com/wp-content/uploads/2024/03/ADM-REFINED-SOYBEAN-OIL-IV-1024x358.jpg)
Full 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 Pharmacopoeia (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). No. R1-CEP 2011-115.
Supported with Drug Master File (DMF) type IV for excipients submitted to the U.S. Food and Drug Administration (FDA). DMF # 028 528.
![ADM Refined Soybean Oil](https://www.pharmaexcipients.com/wp-content/uploads/2024/03/ADM-Refined-Soybean-Oil-1024x302.jpg)
Process Control for High-Quality Pharmaceutical Ingredients
The precise control of our refining process enables us to guarantee the best batch-to-batch consistency.
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.
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
HIGH STABILITY GUARANTEE
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.
See the full technical brochure on “ADM Refined Soybean Oil IV” here
(click the picture to download the brochure)
Source: ADM technical brochure “ADM Refined Soybean Oil IV“
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