Cremophor ® ELP

® = Registered trademark of BASF Aktiengesellschaft

Solu­bi­li­ser for the pharmaceu­ti­cal i­ndu­stry

Techni­cal Informati­on

May 2007Su­persedes i­ssu­e dated November 2005

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Exci­pi­ents

cti­ves

Contract Manu­factu­ri­ng

Valu­e dded

Cremophor ELP, a purified grade of Cremophor EL was specially developed for sensi­tive active ingredients, as the higher purity was found to improve their stability.

Chemi­cal natu­re Like Cremophor EL, Cremophor ELP is a nonionic solubiliser made by reacting castor oil with ethylene oxide in a molar ratio of 1 : 35. This is followed by a purification process.

Descri­pti­on Unlike Cremophor® EL, Cremophor ELP is a white to yellowish paste or cloudy liq­uid. It has to fulfill more exacting req­uirements with regard to water content, potassium ions and free fatty acids, particularly ricinoleic, oleic and palmitic acids. On heating, the last solid constituents melt at 26 °C to yield a clear oily liq­uid with a weak but characteristic odour. The HLB value lies between 12 and 14. The critical micelle concentration (CMC) lies at approx. 0.02%.

 Pharmacopœi­as Cremophor ELP meets the req­uirements of the current Ph.Eur. Monograph, “Macrogolglycerol Ricinoleate”. It also conforms to the latest monograph, “Polyoxyl 35 Castor Oil”.

Solu­bi­li­ty Cremophor ELP forms clear solutions in water and also dissolves in a wide range of organic solvents, such as ethanol, n­propanol, isopropanol, ethyl ace­tate, chloroform, carbon tetrachloride, trichloroethylene, toluene and xylene.

Speci­fi­cati­on Appearance White to slightly yellowish pasteIdentification ConformsAlkalinity ConformsSaponification value 65–70Acid value 2.0 Hydroxyl value 65–78 Iodine value 25–35Water 0.5%pH (10% in water) 5.0 – 7.0Ethylene oxide 1 1,4­dioxane 10 ppmClarity (10 % in water) Conforms Colour (10 % in water) max. BY6

Density (25 °C) 1.05–1.06 g/mlViscosity (25 °C) 600–750 mPa · sSulphated ash (USP­NF) 0.2 %Ash (Ph.Eur.) 0.2 %Heavy metals 10 ppmPotassium 15 ppmFree fatty acids (C12–C18) (GC) 1.0%Ricinoleic acid (HPLC) 0.2%Oleic acid (HPLC) 0.1%Palmitic acid (HPLC) 0.1%

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Residual solvents (Ph. Eur. 5.4):

Only the Class ll solvents, ethylene glycol, and 1,4­dioxane, and Class III solvents are likely to be present. Residual ethylene glycol is below the Option 1 limit of 620 ppm. Residual 1,4 dioxane is below the Option 1 limit of 380 ppm and is separ­ately specified. Residual Class III solvents are below 0.5%.

Microbiological Status (Cat. 2 + 3 a)

Conforms

Unless otherwise indicated, the methods used to determine the figures q­uotedabove are those given in the Ph.Eur. monograph, “Macrogolglycerol Ricinoleate” and USP­NF monograph, “Polyoxyl 35 Castor Oil”.

ppli­cati­ons One possible field of application that can be considered for Cremophor ELP is in parenteral dosage forms. Thus Cremophor ELP is suitable for particularly demanding formulations, which prove not to achieve the desired stability when Cremophor EL is used. For other injectables, we recommend Solutol® HS 15 as a solubiliser. For further information, please see the Technical Data Sheets for Cremophor EL and Solutol HS 15.

Toxi­cology No toxicological studies have been carried out on Cremophor ELP itself. Please refer to the toxicological findings for Cremophor EL.

PBG-Nu­mber 10205104

PRD-Nu­mber 30035162

Pack­agi­ng 60­kg removable­head steel drum with a Lupolen® inliner with its own lid.

Storage Cremophor ELP should be stored in tightly closed containers protected from light. Prolonged storage is not recommended unless the containers are completely full.

 Shelf li­fe Cremophor® ELP is stable for at least 24 months if stored in the unopened original containers at room temperature (max. 25 °C).

Safety Data Sheet A Safety Data Sheet is available for Cremophor ELP.

Note The data contained in this publication are based on our current knowledge and experience. In view of the many factors that may affect processing and application of our product, these data do not relieve processors from carrying out their own investigations and tests; neither do these data imply any guarantee of certain properties, nor the suitability of the product for a specific purpose. Any descriptions, drawings, photographs, data, proportions, weights etc. given herein may change without prior information and do not constitute the agreed contractual q­uality of the product. It is the responsibility of the recipient of our products to ensure that any proprietary rights and existing laws and legislation are observed. May 2007

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BSF k­ti­engesellschaftFine Chemicals Division ­ Pharma Solutions ­ 67117 Limburgerhof ­ www.pharma­solutions.basf.com

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