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OCTENIDINE HYDROCHLORIDE (Octenidin Hidroklorit)

OCTENIDINE HYDROCHLORIDE

CAS Number: 70775-75-6

 

 

 

 

OCTENIDINE HYDROCHLORIDE;Octenidine (dihydrochloride);UNII-U84956NU4B;Octenidine HCl;Win-414642;Win 41464-2;AC1L1AKV;CHEMBL36342,SCHEMBL126065;Octenidine hydrochloride (USAN);HY-B2170A;DTXSID90221025;U84956NU4B;71251-02-0 (Parent);EINECS 274-861-8;MFCD01938808;CS-6224;KS-000002K2;AN-37614;O0388;D05222;1-Octanamine,N,N'-(1,10-decanediyldi-1(4H)-pyridinyl-4-ylidene)bis-, hydrochloride (1:2);N,N'-(1,10-Decanediyldi-1(4H)-pyridinyl-4-ylidene)bis(1-octanamine) dihydrochloride;N-octyl-1-[10-(4-octylimino-1-pyridyl)decyl]pyridin-4-imine dihydrochloride;N-octyl-1-[10-(4-octyliminopyridin-1-yl)decyl]pyridin-4-imine dihydrochloride;TENIDINE HYDROCHLORIDE;DIHYDROGEN N-(1-{10-[4-(OCTYLIMINO)PYRIDIN-1-YL]DECYL}PYRIDIN-4-YLIDENE)OCTAN-1-AMINE DICHLORIDE;DR003398;LP107310;1-Octanamine,N,N'-(1,10-decanediyldi-1(4H)- pyridinyl-4-ylidene bis-,dihydrochloride;;1-octanamine, N,N'-(1,10-decanediyldi-1(4H)-pyridinyl-4-ylidene)bis-, dihydrochloride;octenidine hydrochloride;N-octyl-1-[10-(4-octyliminopyridin-1-yl)decyl]pyridin-4-imine;dihydrochloride;Octenidine Dihydrochloride >98.0%(HPLC)(N);N,N'-(1,1'-(decane-1,10-diyl)bis(pyridin-1(1H)-yl-4(1H)-ylidene))bis(octan-1-amine) dihydrochloride ;Internal standard, Internal standard Octenidine, HPLC-MS method validation, HPLC-MS method validation Octenidine, LC-MS-MS method validation, LC-MS-MS method validation Octenidine, Deuterated internal standard, Deuterated internal standard Octenidine, Deuterated Octenidine, Deuterium labeled Octenidine, Quantitative bioanalytical methods, Quantitative bioanalytical methods Octenidine, Blood samples Octenidine, Blood concentrations, Heavy drugs, Analysis, Analysis Octenidine, Clinical diagnostic, Clinical diagnostic Octenidine, Dosing Octenidine, Analytical method development, Internal standard method; Octenidine : API Standards;Octenidine : Stable Isotopes;Octenidine : Metabolites;Octenidine : Impurities;Octenidine : Glucuronides;1,1',4,4'-Tetrahydro-N,N'-dioctyl-;1,1'-decametylenedi-(4-pyridylideneamine);1,1'-Decametylenbis[1,4-dihydro-4-(octylimino) pyridin] (IUPAC);1,1'-Decametylenebis[1,4-dihydro-4-(octylimino) pyridine] (WHO);Octenidine (OS: BAN);Octénidine (OS: DCF);Win 41464 (IS: SterlingWinthr);Octenidine Hydrochloride (OS: BANM, USAN);Win 41464-2 (IS: SterlingWinthr);Stellisan;Octenisept ;Octenimed;Oseptin;Linoseptic; Echinococcus granulosus, in vitro effect, octenidine hydrochloride; Antimicrobial, chlorhexidine, irrigation, octenidine;WIN 41,464-6 | OCTENIDINE SACCHARIN | WIN 41464-2 | OCTENIDINE | OCTENIDINE HYDROCHLORIDE | Octenidine;Octenidine dihydrochloride
;1,1'-(1,10-Decandiyl)bis(N-octyl-4(1H)-pyridinimin)dihydrochlorid [German] [ACD/IUPAC Name];1,1'-(1,10-Decanediyl)bis(N-octyl-4(1H)-pyridinimine) dihydrochloride [ACD/IUPAC Name];1,1'-(1,10-Décanediyl)bis(N-octyl-4(1H)-pyridinimine), dichlorhydrate [French] [ACD/IUPAC Name];1,1'-Decamethylenebis(1,4-dihydro-4-(octylimino)pyridine) dihydrochloride;1,1'-Decane-1,10-diylbis[4-(octylamino)pyridinium] dichloride;1-Octanamine, N,N'-(1,10-decanediyldi-1-pyridinyl-4-ylidene)bis-, hydrochloride (1:2) [ACD/Index Name];265-020-6 [EINECS];274-861-8 [EINECS];70775-75-6 [RN];N,N'-(Decane-1,10-diyldipyridin-1-yl-4-ylidene)dioctan-1-amine dihydrochloride;N,N'-(decane-1,10-diyldipyridin-1-yl-4-ylidene)dioctan-1-aminium dichloride pyridinium, 1,1'-(1,10-decanediyl)bis[4-(octylamino)-, chloride (1:2);UNII:U84956NU4B;Win 41464-2;[70775-75-6];1,1'-(1,10-Decanediyl)bis(4-(octylamino)pyridinium) dichloride;1,1'-(Decane-1,10-diyl)bis(4-(octylamino)pyridin-1-ium) chloride;1,1'-(Decane-1,10-diyl)bis(4-(octylamino)pyridinium) dichloride;1,1'-(decane-1,10-diyl)bis[4-(octylamino)pyridinium] dichloride;1,10-Bis(4-(octylamino)-1-pyridinium)decane dichloride;1-[6-(4-iminio-N-octyl-pyridin-1(4H)-yl)-decyl]pyridin-4(1H)-iminium-N'-octyl- dichloride;1-Octanamine, N,N'-(1,10-decanediyldi-1(4H)-pyridinyl-4-ylidene)bis-, dihydrochloride;4-(OCTYLAMINO)-1-{10-[4-(OCTYLAMINO)PYRIDIN-1-IUM-1-YL]DECYL};PYRIDIN-1-IUM DICHLORIDE;71251-02-0 [RN];DIHYDROGEN N-(1-{10-[4-(OCTYLIMINO)PYRIDIN-1-YL]DECYL};PYRIDIN-4-YLIDENE)OCTAN-1-AMINE DICHLORIDE;MFCD01938808 [MDL number];MFCD29050406;N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride;N,N'-[Decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene]bis(octylammonium) dichloride;N-octyl-1-[10-[4-(octylamino)pyridin-1-ium-1-yl]decyl]pyridin-1-ium-4-amine dichloride;octenidine hydrochloride;Pyridinium, 1,1'-(1,10-decanediyl)bis(4-(octylamino)-, dichloride;UNII-U84956NU4B;1-Octanamine, N,N'-(1,10-decanediyldi-1(4H)-pyridinyl-4-ylidene)bis-, dihydrochloride;N,N'-(1,10-Decanediyldi-1(4H)-pyridinyl-4-ylidene)bis-1-octanamine Hydrochloride; Neo Kodan; Octeniderm; Octenidine Hydrochloride; Win 41464-2;(R)-Ostarine;(R)-Ostarine;11-Oxo Fluticasone Propionate;2-Oxo-3-hydroxy-LSD (0.1 mg/ml);4-tert-Octylphenol Monoethoxylate;5-Oxo-Zaleplon;Clidinium Bromide;Codeine Phosphate Hemihydrate;Desmethylchlorphenamine Maleate;Desmethylchlorphenamine Maleate 1.0 mg/ml in Methanol (as free base);N-Oleoyl Dopamine solution in ethanol;N-Oleoyl Taurine solution in DMSO;N-Oleoyl-L-Serine solution in ethanol;O-1602 solution in methyl acetate;O-2545 (hydrochloride);Octacaine Hydrochloride;Octaphonium Chloride;Octaverine Hydrochloride;Octenidine Dihydrochloride;Octinoxate;Octocrylene;Octyl Gallate;Ofloxacin;Ohmefentanyl;Olanzapine;;1-octanamine, N,N'-(1,10-decanediyldi-1(4H)-pyridinyl-4-ylidene)bis-, dihydrochloride;octenidine hydrochloride;N-octyl-1-[10-(4-octyliminopyridin-1-yl)decyl]pyridin-4 imine;dihydrochlorideN,N'-(1,10-Decanediyldi-1(4H)-pyridinyl-;4-ylidene)bis(1octanaminedihydrochloride;Octenidine dihydrochloride;1,1′-(1,10-Decandiyl)bis(N-octyl-4(1H)-pyridinimin)dihydrochlorid [German] [ACD/IUPAC Name];1,1′-(1,10-Decanediyl)bis(N-octyl-4(1H)-pyridinimine) dihydrochloride [ACD/IUPAC Name];1,1′-(1,10-Décanediyl)bis(N-octyl-4(1H)-pyridinimine), dichlorhydrate [French] [ACD/IUPAC Name];1,1′-Decamethylenebis(1,4-dihydro-4-(octylimino)pyridine) dihydrochloride;1,1′-Decane-1,10-diylbis[4-(octylamino)pyridinium] dichloride;1-Octanamine, N,N'-(1,10-decanediyldi-1-pyridinyl-4-ylidene)bis-, hydrochloride (1:2) [ACD/Index Name];265-020-6 [EINECS];274-861-8 [EINECS];70775-75-6 [RN];N,N'-(Decane-1,10-diyldipyridin-1-yl-4-ylidene)dioctan-1-amine dihydrochloride;N,N'-(decane-1,10-diyldipyridin-1-yl-4-ylidene)dioctan-1-aminium dichloride pyridinium, 1,1′-(1,10-decanediyl)bis[4-(octylamino)-, chloride (1:2);Win 41464-2;[70775-75-6];1,1′-(1,10-Decanediyl)bis(4-(octylamino)pyridinium) dichloride;1,1′-(Decane-1,10-diyl)bis(4-(octylamino)pyridin-1-ium) chloride;1,1′-(Decane-1,10-diyl)bis(4-(octylamino)pyridinium) dichloride;1,1′-(decane-1,10-diyl)bis[4-(octylamino)pyridinium] dichloride;1,10-Bis(4-(octylamino)-1-pyridinium)decane dichloride;1-[6-(4-iminio-N-octyl-pyridin-1(4H)-yl)-decyl]pyridin-4(1H)-iminium-N'-octyl- dichloride;1-Octanamine, N,N'-(1,10-decanediyldi-1(4H)-pyridinyl-4-ylidene)bis-, dihydrochloride;4-(OCTYLAMINO)-1-{10-[4-(OCTYLAMINO)PYRIDIN-1-IUM-1-YL]DECYL}PYRIDIN-1-IUM DICHLORIDE;71251-02-0 [RN]DIHYDROGEN N-(1-{10-[4-(OCTYLIMINO)PYRIDIN-1-YL]DECYL}PYRIDIN-4-YLIDENE)OCTAN-1-AMINE DICHLORIDE;MFCD01938808 [MDL number];MFCD29050406;N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bi(octylammonium) dichloride;N,N'-[Decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene]bis(octylammonium) dichloride;N-octyl-1-[10-[4-(octylamino)pyridin-1-ium-1-yl]decyl]pyridin-1-ium-4-amine dichloride;Octenidine dihydrochloride 98%;octenidine hydrochloride Pyridinium, 1,1′-(1,10-decanediyl)bis(4-(octylamino)-, dichloride;UNII:U84956NU4B;UNII-U84956NU4B;sensidin® DO;Octenidine hydrochloride suppliers; Octenidine hydrochloride msds;Octenidine hydrochloride uses;Octenidine hydrochloride price;Octenidine hydrochloride lotion;Octenidine hydrochloride solution;Octenidine hydrochloride wiki;Octenidine hydrochloride solubility;oseptin antisepitik;osebtin antiseptik; oseptin çözeltisi;oseptin losyon; OSEPTIN;OSEPTİN;OSEPTİK;OSEPTİN ANTİSEPTİK;OSEPTIN ANTISEPTIK; OCTEDINE HYDROCHLORIDE; OCTEDİNE HDROCHLORIDE; OCTENIDE HYDROCHLORIDE.

 

 

 

 

 

OCTENİDİN HİDROKLORİT

Octenidin dihidroklorür (oktenidin), 20 yıl önce cilt, müköz membran ve yara antisepsisi için kullanılmıştır. Oktenidin dihidroklorür (N, N '- (1,1-0-Decandiild-1 (4-H) -piridinil-4iliden) bis 1-oktanamin) -dihidroklorür - CAS No 70775-75-6), tüm memeli gıda üretim türlerinde deri ve mukozal dezenfeksiyon için kullanılan ve kısa süreli destekleyici antiseptik yaranın antiseptik bir ajandır.

Octenidine hydrochloride CAS no.70775-75-6 API, farmasötik endüstrisine aktif farmasötik katkı maddesi.Oktenidin dihidroklorür cilt mukoza zarları ve yaraları için etkili bir antiseptik bileşiktir.
Octenidin dihidroklorür cilt, müköz membran ve yara antisepsi için% 0.1-2.0 konsantrasyonlarda kullanılan katyonik bir yüzey aktif madde ve bis- (dihidropiridinil) -dekan türevidir. Octenidin dihidroklorür, Octenidin dihidroklorür eyleminde kuaterner amonyum bileşiklerine benzer ancak, daha geniş bir etki yelpazesine sahiptir. Oktenidin şu an kıta Avrupa'sında su ya da alkol bazlı cilt, mukoza ve yara antiseptiklerinde kuats ya da klorheksidin yerine geçer. Sulu formülasyonlarda Octenidin dihidroklorür, genellikle 2-fenoksietanol ilavesiyle güçlendirilir. Oktenidin dihidroklorür, deri ve mukozal dezenfeksiyon için tüm memeli gıda üreten türlerde ve kutanöz kullanım için% 0.1 sulu solüsyon olarak kısa süreli destekleyici antiseptik yara tedavisinde kullanılmak üzere tasarlanmıştır . Oktenidin dihidroklorür (N, N '- (1,10-Decandiild-1 (4-H) -piridinil-4iliden) bis (1-oktanamin) -dihidroklorür - CAS No 70775-75-6) cilt ve mukozal dezenfeksiyon için tüm memeli gıda üreten türlerde ve kutanöz kullanım için% 0.1 sulu solüsyon olarak kısa süreli destekleyici antiseptik yara tedavisinde kullanın.
Octenidin dihidroklorür, in vitro geniş bir yelpazede bakteri ve bazı mantarlara karşı antiseptik aktivite gösterir. Oktenidin dihidroklorür için en düşük MIC değeri (1 ppm) Staphylococcus aurerus için gözlenmiştir. Oktenidin dihidroklorür MRSA suşları için diğer incelenenlerden daha düşük bir MIC değeri gösterdi
antiseptikler.

Yapılan çalışmaların çoğunda, oktenidin dihidroklorür potansiyel genotoksik etkileri tek bir madde olarak değerlendirildi. Buna ek olarak,% 0.1 oktenidin dihidroklorür içeren sabit bir kombinasyon ürünü de bazı genotoksisite analizlerinde test edildi. Temel genotoksisite çalışmaları GLP'ye göre yapılmıştır.

 

Octenidin dihidroklorür, S9 varlığında ve yokluğunda, Salmonella suşları TA 98, TA 100, TA 1535, TA 1537, TA 1538 ve TA102'deki Ames testlerinde 5 µg / plakaya kadar test konsantrasyonları kullanılarak negatif bulunmuştur. 5 µg / plaka ve daha yüksek konsantrasyonlarda oktenidin dihidroklorür bakteriler için zehirlidir.

 

Octenidin dihidroklorür, bakterilerdeki gen mutasyonlarına karşı genotoksik bir potansiyel göstermedi.

Octenidin dihidroklorür, kültürlenmiş Çin hamster yumurtalık hücrelerinde veya insan lenfositlerinde, S9 aktivasyonu olsun veya olmasın, kromozomal sapmaları indüklemedi. Oktenidin dihidrokloridin genotoksisitesi L5178Y hücrelerinde Mouse Lymphoma TK lokus tahlilinde in vitro araştırılmıştır. Oktenidin dihidroklorür EMA / CVMP / 7000219/2009 Sayfa 4/11 sonuçları için Avrupa halkı MRL değerlendirme raporu (EPMAR) negatifti. Özetlemek gerekirse, in vitro memeli hücre testlerinde oktenidin dihidroklorürün genotoksik potansiyeline dair bir kanıt bulunmamaktadır.

 

32 mg / kg'lık tek bir oral dozda erkek ve dişi farelerde in vivo memeli kemik iliği eritrosit mikronukleus tahlilinde oktenidin dihidroklorür genotoksik aktivite göstermedi. Ana testteki doz,

Yüksek dozlarda kemik iliğinde toksik etkilerin görüldüğü ön toksisite testi.

Sonuç olarak, oktenidin dihidroklorürün genotoksisitesi yeterince incelenmiş ve kanıt ağırlığı, oktenidin dihidroklorürün genotoksik olmadığı sonucuna varmak için yeterlidir.

 

Octenidin dihidroklorür, in vitro geniş bir yelpazede bakteri ve bazı mantarlara karşı antiseptik aktivite gösterir. Oktenidin dihidroklorür için en düşük MIC değeri (1 ppm) Staphylococcus aurerus için gözlenmiştir. Octenidin dihidroklorür MRSA suşları için diğer antiseptiklerden daha düşük bir MIC değeri gösterdi. Cynomolgus maymunun el ve ayaklarında oktenidin dihidroklorürün ciltli olarak uygulanması, ikamet mikroflorasını deride düşürdü. Bu azalma, yoğunlaşma ve başvuru sayısına bağlıydı.

İkincil farmakodinamikler veya farmakodinamik ilaç etkileşimleri hakkında herhangi bir çalışma sunulmamıştır.

Oktenidin hihidroklorür gibi katyonik maddelerin anyonik maddelerle reaksiyona girmesi ve böylece antiseptik etkiyi bozması gerçeğine rağmen. Bununla birlikte, ikincil farmakodinamik ve ilaç etkileşimi araştırmalarının eksikliği, literatürde mikrop öldürücü etkiler dışında farmakodinamik etkiler hakkında hiçbir bilgi bulunmadığından ve oktenidin dihidroklorür ile yapılan farmakokinetik çalışmalarda, kutanöz uygulama sonrasında sistemik bir maruziyetin düşük olduğunu belirttiği için haklı kabul edilmiştir.

 

OCTENİDİN HİDROKLORİTİN KİMYASAL VE FİZİKSEL ÖZELLİKLERİ

Moleküler yapı: C33H.64Cl₂N4
Görünüm: Beyaz ila Sarımsı Katı
Erime Noktası:> 207ºC (dec.)
Mol. Ağırlık: 623,83
Depolama: Higroskopik, Buzdolabı, inert atmosfer altında
Çözünürlük: DMSO (Hafif), Metanol (Hafif)
Kararlılık: Mevcut Veri Yok
Kategori: Aminler, Heterosiklikler, İlaçler, Ara ürünler ve İnsanlar
Kaynama Noktası: Mevcut Veri Yok

 

OCTENİDİN HİDROKLORİTİNİN UYGULANMASI

Octenidin antiseptiktir (topikal). Octenidin katyonik bir yüzey aktif cismi ve bis (dihidropiridinil) -dekan türevidir.
Octenidin dihidroklorür cilt, müköz membranlar ve yaralar, ilaçlar için modern antiseptik olarak kullanılır
Biyolojik Rol (ler)
Octenidin dihidroklorür farmakolojik rolü olarak biyolojik rollere sahiptir
Kimyasal Rol (ler)
Octenidin dihidroklorür, Brønsted asit, yüzey aktif madde olarak kimyasal rollere sahiptir
Kimyasal Varlık
Octenidin dihidroklorür hidroklorür, piridinler, sekonder amin olarak kimyasal varlıklara sahiptir.

 


OCTENİDİN HİDROKLORİTİN DEPOLANMASI

10 ° C ile 35 ° C arasındaki sıcaklıklarda ışığı ve nemi koruyan hava geçirmez kaplarda saklayın. Raf ömrü uygun koşullarda depolandığında üretim tarihinden itibaren 24 aydır.

 

 

 

 

 

 

 

 

 

OCTENIDINE HYDROCHLORIDE

Octenidine dihydrochloride (octenidine) was introduced for skin, mucous membrane and wound antisepsis more than 20 years ago.Octenidine dihydrochloride (N,N'-(1,1 0-Decandiyldi-1 (4-H)-pyridynyl-4yliden)bis(1-octanamine)-dihydrochloride - CAS No 70775-75-6) is an antiseptic agent intended for use in all mammalian foodproducing species for skin and mucosal disinfection and short-term supportive antiseptic wound
treatment as a 0.1% aqueous solution for cutaneous use. Hydatid disease is still endemic in many devoloping countries and continues to be an important causeof morbidity. The objective of this study was to determine the in vitro scolicidal effects of octenidine hydrochloride in different concentrations using different exposure times. After hydatid cyst liquid was left to precipitate for 1 h to obtain cystic sand, various concentrations of octenidine (undiluted, 1% and 0.1% diluted) were added to concentrated hydatid cyst sediments for 5, 10, 15, 20, 25, 30, 45, and 60 min, and scolicidal effects of octenidine were compared with 20% saline and control group for the same times. It was found that undiluted octenidine had a strong scolicidal effect at 15 min compared to saline at 20%. One percent octenidine had a scolicidal effect at 30 min. However, 0.1% octenidine did not have enough scolicidal effect in 1 h. It was concluded that undiluted and 1% diluted octenidine might be used for scolicidal purpose in the treatment of hydatid disease. Octenidine hydrochloride CAS no.70775-75-6, API, active pharmaceutical ingredients, intermediates, with documentation and certification, DMF, FDA, US Drug Master Files. We offer as per requirements of RND/ Development quantities or commercials, Buy high quality source with supportive technical package.

Octenidine hydrochloride CAS no.70775-75-6 API, active pharmaceutical ingredient to the pharmaceutical industry. Our Octenidine hydrochloride CAS no. 70775-75-6 is manufactured by cGMP compliant facility. Welcome to contact us for further details including current DMF status for the product . We look forward to assisting you with your research and development projects.Octenidine dihydrochloride is an effective antiseptic compound for skin mucous membranes and wounds.
Octenidine dihydrochloride is a cationic surfactant and bis-(dihydropyridinyl)-decane derivative used in concentrations of 0.1-2.0% for skin, mucous membrane and wound antisepsis. Octenidine dihydrochloride is similar in Octenidine dihydrochloride action to quaternary ammonium compounds, but is of somewhat broader spectrum of activity. Octenidine is currently increasingly used in continental Europe as a substitute for quats or chlorhexidine in water- or alcohol-based skin, mucosa and wound antiseptics. In aqueous formulations, Octenidine dihydrochloride is often potentiated with addition of 2-phenoxyethanol.Octenidine dihydrochloride is intended for use in all mammalian food producing species for skin and mucosal disinfection and short-term supportive antiseptic wound treatment as a 0.1% aqueous solution for cutaneous use. Octenidine dihydrochloride (N,N'-(1,1 0-Decandiyldi-1 (4-H)-pyridynyl-4yliden)bis(1-octanamine)-dihydrochloride - CAS No 70775-75-6) is an antiseptic agent intended for use in all mammalian food producing species for skin and mucosal disinfection and short-term supportive antiseptic wound treatment as a 0.1% aqueous solution for cutaneous use.
Octenidine dihydrochloride shows antiseptic activity against a wide range of bacteria and some fungus in vitro. The lowest MIC value (1 ppm) for octenidine dihydrochloride was observed for Staphylococcus aurerus. Octenidine dihydrochloride showed a lower MIC value for the MRSA strains than other studied
antiseptics.

 

CHEMICAL AND PHYSICAL PROPERTIES OF OCTENIDINE HYDROCHLORIDE

Molecular form.: C₃₆H₆₄Cl₂N₄
Appearance: White to Off-White Solid
Melting Point: >207ºC (dec.)
Mol. Weight: 623.83
Storage: Hygroscopic, Refrigerator, under inert atmosphere
Solubility: DMSO (Slightly), Methanol (Slightly)
Stability: No Data Available
Category: Amines, Heterocycles, Pharmaceuticals, Intermediates & Fine Chemicals
Boiling Point: No Data Available

 

APPLICATION OF OCTENIDINE HYDROCHLORIDE

Octenidine is an antiseptic (topical). Octenidine is a cationic surfactant and bis (dihydropyridinyl)-decane derivative.
Octenidine dihydrochloride is used as modern antiseptic for skin, mucous membranes and wounds, drug
Biological Role(s)
Octenidine dihydrochloride has biological roles as pharmacological role
Chemical Role(s)
Octenidine dihydrochloride has chemical roles as Brønsted acid, surfactant
Chemical Entity
Octenidine dihydrochloride has chemical entities as hydrochloride, pyridines, secondary amine.

 

Octenidine dihydrochloride (N,N'-(1,1 0-Decandiyldi-1 (4-H)-pyridynyl-4yliden)bis(1-octanamine)-dihydrochloride - CAS No 70775-75-6) is an antiseptic agent intended for use in all mammalian food producing species for skin and mucosal disinfection and short-term supportive antiseptic wound treatment as a 0.1% aqueous solution for cutaneous use.

Octenidine dihydrochloride has been used as an antiseptic agent in human medicine.

 

Substance name: Octenidine dihydrochloride

Therapeutic class: Anti-infective agents/Antiseptics

Target species: All mammalian food producing species

Intended therapeutic indication: Skin and mucosal disinfection and short-term antiseptic wound

treatment

Route(s) of administration: Cutaneous

 

Octenidine dihydrochloride is intended for use in all mammalian food producing species for skin and mucosal disinfection and short-term supportive antiseptic wound treatment as a 0.1% aqueous solution for cutaneous use.

Based on the original and complementary data in the dossier, the Committee for Medicinal Products for Veterinary Use recommended on 8 February 2011 the establishment of maximum residue limits for octenidine dihydrochloride in all mammalian food producing species.

On 12 July 2011 the European Commission requested a reconsideration of the opinion of 8 February 2011 to review the possibility of extrapolation to poultry, eggs and honey.

On 15 September 2011 the Committee for Medicinal Products for Veterinary Use considered the Commission's request, reviewed the considerations with regard to extrapolations and confirmed the recommendation for the establishment of maximum residue limits for octenidine dihydrochloride in all mammalian food producing species.

In most of the performed studies octenidine dihydrochloride was evaluated for potential genotoxic effects as a single agent. In addition, a fixed combination product containing 0.1% octenidine dihydrochloride, was also tested in some genotoxicity assays. Pivotal genotoxicity studies were performed according to GLP.

 

Octenidine dihydrochloride, in the presence and absence of S9, was negative in Ames tests in Salmonella strains TA 98, TA 100, TA 1535, TA 1537, TA 1538 and TA102 using test concentrations up to 5 µg/plate. At concentrations of 5 µg/plate and higher, octenidine dihydrochloride was toxic to the bacteria. Octenidine dihydrochloride showed no genotoxic potential with respect to gene mutations in bacteria.

 

Octenidine dihydrochloride did not induce chromosomal aberrations in cultured Chinese hamster ovary cells or in human lymphocytes, with or without S9 activation. The genotoxicity of octenidine dihydrochloride was investigated in vitro in the Mouse Lymphoma TK locus assay in L5178Y cells

results were negative. To summarise, there is no evidence of genotoxic potential of octenidine dihydrochloride in the in vitro mammalian cell tests.

In an in vivo mammalian bone marrow erythrocyte micronucleus assay in male and female mice with a single oral dose of 32 mg/kg, octenidine dihydrochloride did not show genotoxic activity. The dose in the main test was based on a preliminary toxicity test in which toxic effects on the bone marrow were seen at high doses.

In conclusion, the genotoxicity of octenidine dihydrochloride has been adequately studied and the weight of evidence is sufficient to conclude that octenidine dihydrochloride is not genotoxic.

 

Octenidine dihydrochloride shows antiseptic activity against a wide range of bacteria and some fungus in vitro. The lowest MIC value (1 ppm) for octenidine dihydrochloride was observed for Staphylococcus aurerus. Octenidine dihydrochloride showed a lower MIC value for the MRSA strains than other studied antiseptics. Cutaneous application of octenidine dihydrochloride on hands and feet of cynomolgus monkey reduced resident microflora on the skin. This reduction was dependent on concentration and number of applications.

 

No studies on secondary pharmacodynamics or pharmacodynamic drug interactions were submitted.

This is despite the fact that cationic substances, like octenidine hihydrochloride, might react with anionic substances and thus impair the antiseptic effect. However, the lack of secondary pharmacodynamic and drug interaction studies was considered justified as no information on Pharmacodynamic effects other than microbicidal effects can be found in the literature and pharmacokinetic studies with octenidine dihydrochloride indicate a low systemic exposure after cutaneous application.

 


STORAGE OF OCTENIDINE HYDROCHLORIDE

Store in airtight containers, protected from light and moisture, between temperatures of 10°C to 35°C. Shelf life is 24 months from date of manufacture when stored in proper conditions.

 

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