Chlorhexidine Digluconate (20% w /v solution) NH NH NH NH Cl– –NH–C–NH–C–NH–(CH2)6–NH–C–NH–C–NH– –Cl · 2CH2(OH) [CH(OH)]4COOH R egulatory S tatus: CAN AD A EU ROP E (Co S # R1 -CEP 1 9 9 3 -0 0 9 Re v0 3 ) J AP AN N EW Z EAL AN D U SA STORAGE Sto r e a t r o o m te m p e r a tu r e (1 5 - 25ºC) p ro te c te d fro m lig h t in th e o rig in a l d ru m s p ro v id e d b y M e d ic h e m . If th e p r o d u c t fre e z e s , it m u s t b e re h o m o g e n iz e d b e fo re u s e , a ll th e p ro p e rtie s re m a in in g u n a lte re d a fte r m e ltin g . STAB IL ITY M e d ic h e m p e r fo r m s o n g o in g s ta b ility s tu d ie s o n Ch lo rh e x id in e s a lts to e n s u re c o n tin u o u s q u a lity th r o u g h o u t th e ir s h e lf life . Sta b ility d a ta g e n e ra te d d u rin g m o re th a n 20 y e a rs o f Ch lo rh e x id in e d ig lu c o n a te p ro d u c tio n h a v e b e e n u s e d to s e t a s h e lf life o f 3 y e a rs (m e ta l d ru m s ) a n d 2 y e a rs (H D P E d ru m s ). Sh e lf life c a n o n ly b e g u a ra n te e d if th e p ro d u c t is s to re d a s in d ic a te d a b o ve . P ACK IN G 1 0 0 0 K g IB C Co n ta in e r s . 50 a n d 20 0 K g H D P E d ru m s . 50 a n d 20 0 K g H D P E lin e d iro n d ru m s . TRAN SP ORT REGU L ATION S Cla s s ifie d a s n o n h a z a r d o u s s u b s ta n c e a c c o rd in g to tra n s p o rt re g u la tio n s . U pdated specification N am e: 1 ,1 ‘-h e x a m e th y le n e b is [5-( p-c h lo ro p h e n y l) b ig u a n id e ] d ig lu c o n a te 1 ,6-b is (N 5 - p- c h lo ro p h e n y l-N ‘d ig u a n id in o ) h e x a n e d ig lu c o n a te F o rm u la : C22 H 3 0 Cl2 N 1 0 · 2C6 H 1 2 O7 M o le c u la r w e ig h t 8 9 7.8 pH 5.5 - 7.0 CAS n u m b e r [1 8 4 72-51 -0 ] D e n s ity 1 .0 6 - 1 .0 7 g /m l Ap p e a ra n c e c le a r c o lo u rle s s o r a lm o s t c o lo u rle s s liq u id . Re la te d s u b s ta n c e s le s s th a n 2% As s a y 1 9 .0 - 21 .0 % w /v Ce rtific a te o f In N o v e m b e r 1 9 9 8 , Su ita b ility M e d ic h e m w a s th e firs t m a n u fa c tu re r o f Ch lo rh e x id in e d ig lu c o n a te to o b ta in th e Ce rtific a te o f Su ita b ility is s u e d b y th e Eu ro p e a n P h a rm a c o p o e ia . le s s th a n 0 .1 % p-Ch lo ro a n ilin e a ro u n d 1 0 p p m BPD Re s id u e o n ig n itio n M e d ic h e m h a s n o tifie d Ch lo rh e x id in e d ig lu c o n a te u n d e r th e B io c id e s P ro d u c t D ire c tiv e (B P D ). 07