Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical 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 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.
Applications & Uses
- Applications
- Dosage Form
Regulatory & Compliance
- Certifications & Compliance
- 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)
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 Sesame Oil IV-1 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
- Shelf Life
- 36 Months
- Stability
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.