Chlorhexidine Dihydrochloride NH NH NH NH Cl– –NH–C–NH–C–NH–(CH2)6–NH–C–NH–C–NH– –Cl · 2HCI R egulatory S tatus: EU ROP E (CTD ) U SA STORAGE Sto r e a t r o o m te mp 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 ms p ro v id e d b y M e d ic h e m. STAB IL ITY M e d ic h e m p e r fo r ms 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 mo re th a n 20 y e a rs o f Ch lo rh e x id in e d ih y d ro c h lo rid e 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 5 y e a rs . 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 v e . P ACK IN G 3 0 a n d 50 K g H D P E d ru ms . So lu b ility (a t 20 ºC) le s s th a n 0 .0 6 % (w /v ) in w a te r p-Ch lo ro a n ilin e a ro u n d BPD M e d ic h e m h a s id e n tifie d Ch lo r h e x id in e d ih y d ro c h lo rid e u n d e r th e B io c id e s P r o d u c t D ir e c tiv e (B P D ). TRAN SP ORT REGU L ATION S Cla s s ifie d a s h a z a rd 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 (c la s s 9 , U N 3 0 7 7 ). U pdated specification N a me : 1 ,1 ‘-h e x a me 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 ih y d ro c h lo rid e 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 ih y d ro c h lo rid e F o rmu la : C22 H 3 0 Cl2 N 1 0 · 2H CI M o le c u la r w e ig h t 57 8 .4 CAS n u mb e r [3 6 9 7 -4 2-5] Ta p p e d b u lk d e n s ity 0 .2 - 0 .4 g /ml Ap p e a ra n c e w h ite p o w e r L o s s o n d ry in g le s s th a n 1 .0 % Re s id u e o n ig n itio n le s s th a n 0 .1 % P a rtic le s iz e Re la te d s u b s ta n c e s le s s th a n 1 .0 % As s a y 9 8 .0 - 1 0 1 .0 % Sta n d a rd D (v,0 .1 ) N M T 3 µm D (v,0 .5) N M T 6 µm D (v,0 .9 ) N M T 1 5 µm d (4 ,3 ) N M T 8 µm 100 ppm M ic ro n is e d D (v,0 .9 ) N M T 1 0 µm 09