From Seed to Solution: The Unrivaled Quality of ADM Refined Sesame Oil IV-1 in Pharma

ADM Refined Sesame Oil IV-1 is a highly purified sesame oil, fully compliant with the:

“European Pharmacopoeia (0433) 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 Excipient in Formulation of Lipophilic Drugs

Refined Sesame Oil IV-1 can be used in Human and Veterinary Applications such as:

Full Compliance with the Most Demanding Regulations

Manufactured under cGMP according to the Joint IPEC-PQG Good Manufacturing Practice Guidance for Pharmaceutical Excipients.

A 5-step purification process is applied to the starting material (refined sesame 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 Drug Master File (DMF) type IV for excipients submitted to the U.S. Food and Drug Administration (FDA). (DMF # 031 697)

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 Sesame Oil IV-1 by closely working with source suppliers. Our 5-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 Sesame Oil IV-1 is perfectly stable over a 36-month shelf life period.

See the full technical brochure on “ADM Refined Olive Oil IV” here

(click the picture to download the brochure)

Source: ADM technical brochure “ADM Refinded Sesame Oil IV-1“

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