REFINED SOYBEAN OIL IV

Description

Refined Soybean 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 from seeds of Glycine max (L). Merr. (Glycine hispida (Moench) Maxim.) by extraction of crude soybean oil followed by a refining process. Refined Soybean Oil IV fully complies with the European Pharmacopoeia monograph “Soya-bean oil, refined”<1473> and USP-NF monograph “Soybean Oil” including general chapters and is intended for use in the manufacture of parenteral preparations. Refined Soybean Oil IV is manufactured under cGMP according to the ICH Q7 Good Manufacturing Practice (GMP) Guidance for APIs and is regulatory supported with a certificate of suitability (CEP, No. R1-CEP 2011-115) and US DMF (type IV, # 028 528 & type II, # 035 560).

HIGH STABILITY GUARANTEE

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

PACKAGING

ADM-SIO’s Refined Soybean 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.