Precision in Every Drop: The Potential of Refined Soybean Oil in Lipophilic Drugs

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:

Active Pharmaceutical Ingredient (API), in parenteral nutrition (e.g. large volume lipid emulsion)
Excipient, for the formulation of poorly soluble drugs

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.

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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