REFINED OLIVE OIL IV

Description

Refined Olive Oil is a pharmaceutical oil, suitable for use as API or excipient in human and veterinary applications in injectable, oral or topical dosage forms. It is obtained by refining of virgin olive oil, obtained by cold expression from the ripe fruit of Olea Europaea Linné, Refined Olive Oil fully complies with the European Pharmacopoeia monograph “Olive oil, refined”<1456> and USP-NF monograph “Olive Oil” including general chapters and is intended for use in the manufacture of parenteral preparations. Refined Olive Oil IV is manufactured under cGMP according to the ICH Q7 Good Manufacturing Practice (GMP) Guidance for APIs and regulatory supported with a certificate of suitability (CEP, No. R0-CEP 2015-167) and US DMF (type IV, # 034 152 & type II, # 035 559).

HIGH STABILITY GUARANTEE

Stability studies performed according to the International Conference on Harmonization (ICH) Q1A Quality Guideline show that Refined Olive Oil IV is perfectly stable over a 36-month shelf life period.

PACKAGING

ADM-SIO’s Refined Olive Oil IV is available in 56,5 Kg or 200 Kg tight-head metal drums that are filled under nitrogen in an ISO 8-classified cleanroom.