Chlorhexidine Dihydrochloride

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