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Cremophor RH 40

Cremophor RH 40

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Published by: Md.ali-bin-saifullah on Sep 09, 2008
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05/17/2013

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Cremophor
®
RH 40
® = Registered trademark o BASF Aktiengesellschat
 For the pharmaceuticals industryCremophor RH 40 is a solubilizer or at-soluble vitamins, essentialoils and other hydrophobic pharmaceuticals. Particular eatures are
that it has very little odour and in aqueous solutions is almost tasteless.
 The use o Cremophor RH 40 grades in cosmetic preparations is thesubject o a separate leaet.
Excipients ctivesContract Manuacturing Value dded
Technical Inormation
May 2007Supersedes issue dated July 2005MEMP 030713e-06/Page 1 o 8
 
MEMP 030713e-06 May 2007Page 2 o8Cremophor RH 40
 
 Generic name
Polyoxyl 40 Hydrogenated Castor Oil (USP, current edition),Macrogolglycerol Hydroxystearate (Ph. Eur., current edition).
Chemical nature
Cremophor RH 40 is a nonionic solubilizer and emulsiying agent obtained byreacting 40 moles o ethylene oxide with 1 mole o hydrogenated castor oil. The main constituent o Cremophor RH 40 is glycerol polyethylene glycoloxystearate, which, together with atty acid glycerol polyglycol esters, orms thehydrophobic part o the product. The hydrophilic part consists o polyethyleneglycols and glycerol ethoxylate.
Properties
Cremophor RH 40 is a white to yellowish paste at 20°C. The HLB value liesbetween 14 and 16.Particular eatures are that it has very little odour and in aqueous solutions isalmost tasteless.
Specifcation
Congealing point1626°CSaponifcation value5060Hydroxyl value6075 Acid value
1lodine value
1Water content, K. Fischer
2%pH value o10% aqueous solution57Colour strength o 10% aqueous solution (Ph. Eur.)Yellow 6 max. Viscosity, Hoeppler, at 25 °C, 30% aqueous solution20–40 mPa · s Ash
0.25%Heavy metals
10 ppmUnless stated otherwise, the analytical methods have been taken romthe monographs “Macrogolglycerol Hydroxystearate” (Ph. Eur.) and “Polyoxyl40 Hydrogenated Castor Oil” (USP/NF). The product ulflls the requirements o these monographs.
Solubility
Cremophor RH 40 orms clear solutions in water, ethanol, 2-propanol,n-propanol, ethyl acetate, chloroorm, carbon tetrachloride, toluene and xylene.Solutions become cloudy as the temperature increases.Cremophor RH 40 can be mixed with all other Cremophors. At elevatedtemperatures it orms clear mixtures with atty acids and atty alcohols.
Stability
 
Pure Cremophor RH 40 is chemically very stable. Prolonged exposure to
elevated temperatures
can cause physical separation into a liquid and a solidphase on cooling but the product can be restored to its original form by homog-enization.
Cremophor RH 40 is stable in aqueous alcohol and purely aqueous solutions.However, it must be noted that strong bases or acids should not be added, asotherwise the ester components may be saponifed.Aqueous Cremophor RH 40 solutions can be sterilized by heating to120°C. Allowance must be made or the act that this can cause a slightdecrease in the pH value. The phases may also separate during sterilization, butthis can be remedied by agitating the solution while it is still hot.The preservatives normally used in the pharmaceuticals industry may be addedto the aqueous solutions. The requisite concentrations should be determined intests.Cremophor RH 40 is largely insensitive to water hardness.
MEMP 030713e-06 May 2007Page 3 o8Cremophor RH 40

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