Chlorhexidine Digluconate

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