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REFINED OLIVE OIL IV

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Description

Your Refined Olive Oil Partner

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

  • As an API for Parenteral Nutrition
  • As an Excipient in Injectable, Oral or Topical Application

Refined Olive Oil IV is produced under cGMP according to ICH-Q7 through the process of virgin olive oil, which is extracted by cold pressing ripe fruit from the Olea Europaea Linné tree and exceeds the strict standards from both the European Pharmacopoeia monograph “Olive oil, refined” <1456> and USP-NF monograph “Olive Oil”. Whether you’re formulating pharmaceuticals for human or veterinary applications, rest assured, you’re receiving unmatched quality and access to a best-in-class solution.

 

Use as an API for parenteral nutrition or Excipient in Formulation of Lipophilic Drugs

Refined Olive Oil IV isn’t just any oil—it’s a versatile ingredient ready to serve as an Active Pharmaceutical Ingredient (API for parenteral nutrition) or excipient in the formulation of lipophilic drugs.

 

Refined Olive Oil IV_icons

APPLICATIONS:

  • Parenteral Nutrition
  • Injectables
  • Syrup
  • Soft Gels

 

Full Compliance with the Most Demanding Regulations

As a cGMP-certified vegetable oil, it complies closely to the ICH-Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, with each step of our process ensuring full quality. Additionally, with certifications like the Certificate of Suitability to the European Pharmacopoeia (CEP) — endorsed by regulatory bodies such as the European Directorate for the Quality of Medicines & Healthcare (EDQM), Drug Master File (DMF) type IV and the U.S. Food and U.S. Drug Administration (FDA)—you can trust in the integrity of this pharma-grade vegetable oil.

 

Process Control for High-Quality Pharmaceutical Ingredients

In the world of pharmaceuticals, consistency is key. By managing source variability and employing a several-step purification process, we guarantee a consistent, high-quality product—batch after batch.

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 Olive 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.

Additional information

Manufacturer

ADM

Quality

EP, USP

Cas-No

8001-25-0

Compendial Name

Olive Oil

Function

Solvent

Documents and Links

Product Information - ADM SIO Refined Olive Oil IV

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