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Cremophor ELP

Cremophor EL is a nonionic solubiliser made by reacting castor oil with ethylene oxide in a molar ratio of 1 : 35. The higher purity was found to improve the stability of sensitive active ingredients. Cremophor ELP forms clear solutions in water and dissolves in a wide range of organic solvents.

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2K views4 pages

Cremophor ELP

Cremophor EL is a nonionic solubiliser made by reacting castor oil with ethylene oxide in a molar ratio of 1 : 35. The higher purity was found to improve the stability of sensitive active ingredients. Cremophor ELP forms clear solutions in water and dissolves in a wide range of organic solvents.

Uploaded by

Md.ali-bin-saifullah
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Technical Information Cremophor ® ELP

May 2007
Supersedes issue dated November 2005

MEMP 030712e-05/Page 1 of 4

® = Registered trademark of Solu­bi­liser for the phar­ma­ceu­ti­cal indus­try


BASF Aktiengesellschaft

Excipients
s
Contract Manufacturing
Value Added
MEMP 030712e-05 May 2007 Page  of 4 Cremophor ELP

Cremophor ELP, a pur­i­fied grade of Cremophor EL was spe­cially devel­oped for sen­si­
tive ­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, n-prop­a­nol, iso­prop­a­nol, ethyl ace­
tate, chlo­ro­form, car­bon tet­ra­chlo­ride, tri­chlo­ro­eth­y­lene, ­toluene and ­xylene.

Spec­ifi­ca­tion Appear­ance White to ­slightly yel­low­ish paste


Iden­tifi­ca­tion Con­forms
Alka­lin­ity Con­forms
Sapon­ifi­ca­tion value 65–70
Acid value  2.0
­Hydroxyl value 65–78
­Iodine value 25–35
Water  0.5%
pH (10% in water) 5.0 – 7.0
Eth­y­lene oxide  1
1,4-diox­ane  10 ppm
Clar­ity (10 % in water) Con­forms
­Colour (10 % in water) max. BY6
Den­sity (25 °C) 1.05–1.06 g/ml
Vis­cos­ity (25 °C) 600–750 mPa · s
Sul­phated ash (USP-NF)  0.2 %
Ash (Ph.Eur.)  0.2 %
Heavy met­als  10 ppm
Potas­sium  15 ppm
Free fatty acids (C12–C18) (GC)  1.0%
Ricin­o­leic acid (HPLC)  0.2%
Oleic acid (HPLC)  0.1%
Pal­mitic acid (HPLC)  0.1%
MEMP 030712e-05 May 2007 Page  of 4 Cremophor ELP

Resid­ual sol­vents Only the Class ll sol­vents, eth­y­lene gly­col, and


(Ph. Eur. 5.4): 1,4-diox­ane, 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 sep­ar­
ately spec­i­fied.
Resid­ual Class III sol­vents are below 0.5%.
Micro­bi­o­log­i­cal Status Con­forms
(Cat. 2 + 3 a)

Unless oth­er­wise indi­cated, the meth­ods used to deter­mine the fig­ures


­quotedabove are those given in the Ph.Eur. mono­graph, “Macrogolglycerol
Ricinoleate” and USP-NF mono­graph, “Poly­oxyl 35 Cas­tor Oil”.

Appli­ca­tions 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 60-kg remov­able-head 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
MEMP 030712e-05 May 2007 Page  of 4 Cremophor ELP

BASF Aktiengesellschaft
Fine Chemicals Division - Pharma Solutions - 67117 Limburgerhof - www.pharma-solutions.basf.com

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