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Praktikum Teknologi Sediaan Steril
Praktikum Teknologi Sediaan Steril
Ampul
010 : Langua belakang homa
E+ anol 1000
Aqua p i . ad I ML
= IML + 0 , 10 mL
= 1 , 1000 Mr
volume 10 ampul =
[ (n +2) Xv + (2x3))
= (12 x 1 , 1000/ ML + 6 ML
= 19 , 2000 mL
-
Fenobarbital Ha =130mg/mL x 19 , 2000 mc =
1496mg = 2 , 4969
-
Etanol =10% x 19 , 2000 mr = 1 , 92 mL
-
PropilenGlikol = 68% x 19 , 2000 mc = 13 , 0560mL
-
Aqua p . i = 19 , 2000 m2 -
(2 , 496 + 1 , 92 + 13 , 0560/ Mr = 1 , 7280mL
* Tonisitas
E Fenobarbital Ha = 0 . 24
E Etanol = 0 , 65
EP GlIKO. = 0 , 43
-
volume = (10 , 24 x 2 , 496) + (0 , 65x 1 , 92) + 10 , 43x13 , 0560)) XIII,
= 829 , 0050 ML
pengusian ↓
Keseragaman volume
PU
QC Sterilitas
nejerninan
neseragaman volume
IPC - PH
-
Pengujian nejerninan
neseragaman volume
pirogenitas
PH
QC sterilitas
nejerninan
neseragaman volume
pirogenitas
OTM
Formulasi : Timolol Male at , 50/0
0
Naz EDTA , 05 %
0
Nach aS
Aqua p : .
ad5ML
* Dibrat 2 OTM ad 5 ML
= (2x5m() + 30 % /2X5mL)
= 13 ML
-
Timolol Maleat = 0 ,5 % x 13 ML = 0 , 0659= 65mg
-
Benzal . Klorida = 0 , 025 % X 13 ML = 0 , 003259 =
3 , 25 my
opengenceran :
Benzal Klorida =
long
Aqua p i . = 13 ML
Benzal ce yg diambil = 3
. 25mg 4 , 23 ML
x 13ML
=
10 mg
-
NazEDTA =0 , 05010 X 13 ML = 0 , 0065 g = 6,5 mg
o Pengenceran :
·
NAcEDTA=lOMG
·
Aqua p i . = 13 ML
10 mg
-
Aqua p i .
=
13 m2 -
(0 , 0659 + 0 , 003259 + 0 , 00659) = 12 , 93 M
* Tonisitas
E Timolol M = 0 , 13
E Benzal Cl = 0 , 16
E NazEDTA = 0 , 23
-v = ((WXE)Timolo/M+(WXE(Benzalce + (WXE) NazEDTA) X 111 , 11
= 1 , 16 ML
% 0 Tonicitas OOO o
MLX0
:
, 900 =
-
NaC = 0 , 82 % x 13 M1 = 0 , 10069 = 106 , 6 my
IPC PH
nejerninan
Pengusian
neseragaman volume
PU
QC Sterilitas
nejerninan
Keseragaman volume
o Rumus Tonisitas (Jinatan dinetahui #(
·
10 Tonisitas = 17 X2
BM
o Rentang PH+UbUh=7-9
Rentang PH Mata = 7-8 . 5
Aseptis (LAF)
o cara verja
1) Disiaphan alat dan bahan
o Pemanasan di oven
o
AUTONICE
o Direndam alnonol
(LAF)
131 Dilanunan usi &C
14) Diberi etinet dan label la dimasuuuan nedalam nemasan
.