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“
Do you need more information or a sample of ADM excipients?