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Technical Information
Isotretinoin
January 2004
Supersedes edition dated November 2002

crystalline Ph.
Eur./USP
Product No. 018933
Isotretinoin
Synonyms
Structural formula
Description
Pure crystalline isotretinoin is a yellow-orange powder whose faint odour resembles that of vitamin A. It melts at around 175 °C.
Solubility
The crystalline product is soluble in chloroform and methylene chloride; it is sparingly soluble in ethanol, 2-propanol and polyethylene glycol (e. g. Lutrol® E 400) and very sparingly soluble in water. Its solubility in soy bean oil is less than 1 mg/100 ml. Specifi cations
er wise stated, the ana lyt i cal meth ods have been taken from the USP/Ph. Eur. mono graphs “Iso tret i noin”. The crys tal line prod uct meets the require ments of these mono graphs. In case of BASF meth ods, they are val i dated. ter File (DMFs) has been sub mit ted to the Food and Drug Admin is tra tion (FDA) of the United States of Amer ica for Iso tret i noin (DMF-No. 4676).
A Drug Mas ter File has also been sub mit ted to the Cana dian Health Pro tec tion Branch for Iso tret i noin (DMF-No. 9669) for cor re spond ing prod uct reg is tra tions. A Euro pean DMF has been sub mit ted, too. Stabil ity
The prod uct is not sta bi lized. It is stable for 36 months if the orig i nal con tain ers are unopened. In com mon with vita min A and its esters, Iso tret i noin has a lim ited stabil ity, so that it must be pro cessed in the absence of light and air.
Particle size distribution
The applied technique is laser light diffraction method (Malvern Master Sizer) in an aqueous suspension.
Appli ca tion
As an active ingre di ent in prep ar a tions for oral and top i cal use in der ma tol ogy, espe cially in acne ther apy. Only per ox ide-free aux il iar ies should be used for pro cess ing. No adju vant that tends to form per ox ide can be con sid ered. The addi tion of an anti ox i dant, e. g. butyl hy drox y to luene is rec om mended. Pack ag ing Alu
min ium cans with PE-inner bag of 10 g, 100 g, 500 g and 5 kg capac ity. The prod uct is fi lled under argon.
Should be kept below 25 °C. Opened pack ages should be fl ushed with nitro gen, tightly closed again and used up as quickly as pos sible. Impor tant note
“It is unlaw ful to sell or offer for sale a dan ger ous sub stance with out indi cat ing in accor dance with § 3 a Sec tion 1 the dan ger relat ing to the sub stance”. Iso tret i noin is affected and is marked with num ber [13].
Iso tret i noin [13] is described in the lit er a ture as terat o genic. Man u fac tur ers of iso tret i noin prep ar a tions must there fore inform the user and the phy si cian that such prep ar a tions must not be taken dur ing preg nancy. Con sid er a tion should be given to com bin ing the prod uct with a con tra cep tive.
In view of the high ther a peu tic effi cacy, cer tain care must be exer cised in pro cess ing. Con tact with and inha la tion of dusts must be avoided.
Product number
Isotretinoin, crystalline (13-cis-retinoic acid, crystalline):18933/1/81 The information submitted in this publication is based on our current knowledge and experience. In view of the many factors that may affect processing and application, these data do not relieve processors of the responsibility of carrying out their own tests and experiments; neither do they imply any legally binding assurance of certain properties or of suit-ability for a specifi c purpose. It is the responsibility of those to whom we supply our products to ensure that any proprietary rights and existing laws and legislation are observed.
BASF AktiengesellschaftFine Chemicals Division67056 LudwigshafenGermany

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