REFINED SOYBEAN OIL IV

Description

Your Refined Soybean Oil Partner

Purified Pharmaceutical GMP Soybean Oil with DMF, EP/USP (Refined Soybean Oil IV) from ADM is compliant for use in various human and veterinary applications:

• As an Excipient in Injectable, Oral or Topical Applications
• As an Active Pharmaceutical Ingredient in Parenteral Nutrition

Refined Soybean Oil IV is derived from the seeds of Glycine max (L). Merr. (Glycine hispida (Moench) Maxim.) through extraction and refining of crude soybean oil. It complies with the European Pharmacopoeia monograph “Soya-bean oil, refined” <1473> and the USP-NF monograph “Soybean Oil,” including all relevant general chapters. Whether you are formulating pharmaceuticals for human or veterinary applications, you can trust that you are receiving a world-class solution.

 

API for Parenteral Nutrition and Excipient Solutions for Enhancing Lipophilic Drug Formulations

This oil offers unmatched quality for use as both an Active Pharmaceutical Ingredient (API for Parenteral Nutrition) and an excipient in the formulation of lipophilic drugs. As an API, it is ideal for parenteral nutrition, particularly in large volume lipid emulsions. As an excipient, it can enhance the formulation of poorly soluble drugs.

 

APPLICATIONS:

• Parenteral Nutrition
• Injectables
• Syrup
• Soft Gels

 

cGMP Manufacturing with ICH-Q7 Compliance, CEP certified and U.S. DMF

Refined Soybean Oil IV is manufactured under the stringent conditions of current Good Manufacturing Practices (cGMP) and in accordance with ICH-Q7 guidelines for Active Pharmaceutical Ingredients. The final purification stages, including fine filtration and drum filling under nitrogen, are conducted in a Class D-classified cleanroom for the utmost purity.

The oil is certified with a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM), guaranteeing its compliance with the European Pharmacopoeia’s monograph for refined soybean oil (1473), No. R1-CEP 2011-115. Additionally, a Drug Master File (DMF) type IV for excipients has been submitted to the U.S. Food and Drug Administration (FDA), with DMF #028 528, for a high-quality, pharma-grade vegetable oil.

 

Process Control and Batch Consistency

This GMP-certified vegetable oil undergoes a meticulous several-step purification process starting from crude soybean oil. By precisely controlling each stage, exceptional batch-to-batch consistency is achieved, which is crucial for pharmaceutical formulations.

High Stability Guarantee

Stability studies conducted in accordance with the International Conference on Harmonization (ICH) Q1A Quality Guideline attest to the enduring stability of Refined Soybean Oil IV over a 36-month shelf life period.

Packaging

Delivered in 56.5 Kg or 200 Kg tight-head metal drums, our product is filled under nitrogen in a Class D-classified cleanroom environment, ensuring its integrity from our facility to yours.