Spesifikasi Reagen 2015 REVISI KE 2
ADDENDUM II
SPESIFIKASI TEKNIS REAGEN
1
Acetonitril for
LC
ACN, methyl cyanide
Synonim
Massa molar
Densitas
Titik didih
Batasan ledakan
4L.05 g/mol
0.786 g/ml
81_.0 - 82,0 "C
3.0 - L7 o/o(V)
>_ 99,9 yo
Assay
2.
Ammonium chloride
Synonim
Sal ammoniac
Temperatur penyalaan
Kelarutan di dalam air
Titik leleh
Massa molar
>400 "c
372 e/l (20 "C)
335 "C (menyublim)
53.49 g/mol
L.52 g/cm3 (20 "C)
500 kglm3
4.5 - 5.5 (50 g/1, HzO, 20 "C)
Densitas
Bulk density
Angka pH
Tekanan uap
3
1-.3 hPa (30 "C)
Ammonium dihydrogen
phosphat
AmmoniunT biphosphate, Ammenium phosphote
Synonyms
monobasic, Primary ommonium phosphote,
M ono a m m o n i u m o'rtho ph o s p h ote
Formula
H6NOaP (NH4H2PO4)
Molekul
Assay
pH
Berat
Titik
4
Ammonium nitrate
leleh
3,8- 4,4 ( pada suhu > 20'C)
nitric acid ammonia
Synonims
Formula
NH+NOs
Assay
pH
4.5
>98%
-
6.0 ( pada suhu > 20"C
)
Synonims
169C
< 0,0005 % (< 5 ppm)
Toluena-4-asam sulfonat monohyd rate
For.mula
CH3C6H4SO:H.HzO
Titik nyala
Berat molekul
Titik didih
Kelarutan dalam
180C
L90,22 g/ml
Pb
5
>98%
19O
Titik leleh
Asam p-toluen Sulfonat
min 115,02 g/mol
air
t40c
67A
gll
PENGADAAN REAGEN T.A 201.5
Baku campuran Aflatoksin
Afla Test HPLC Kit
Benzalkonium Chloride
dalam
81 :82:G1 :G2 (1:0,3:1':0,3)dengan konsentrasi 2,6yglml
metanol
: G1 :G2
100 kolom dan l set standar baku campuran Aflatoksin BL : 82
alkylbenzyldimethyla m monium chloride
Synonims
Titik leleh
De
n
sita s
pH
40
0c
0,98 g/cm3
5-6
3)2
Cadmium standard
densitv
Synonims
Formula
Chloroform
Assay
Densita
s
L,O!3 glcm3 (2ooc)
Methylidyne trichloride, Trichloromethane
cHcl3
>99,8%
1,48 glmL at 25 "C(lit.)
Tertelusur pada SRM dari NIST dan
Dapar asetat (Buffer
in HNO3 0,5 mol/l, 1000 mg/L
PTB
Densltas
1,00 g/cm3
di-Ammonium HYdrogen
Synonims
ammonium phosphate
olprr
Rn rnonir* biphosphate,
Ammonlum
Phospat
dibasic
Solution Acetic Acid
PH
molekul
Bulk densitY
pH
Berat
Disodium hydrogen
Phosphate HePtahYd rate
Dodecylsulfat sodium
Salt
Na2HP04.7HzO
Berat molekul
pH
min 268,03 g/mol
8,7 -9,3
Densitas
1,68 g/cm3
Synonims
Formula
Lauryl sulfate sodium salt
PTFE
CrzHzsNaOaS
Titik leleh
min 288,37 g/mol
204 -207 c
Assay
> 99,0
Synonims
Formula
Ethyl alcohol
Assay
95,1
Keasa
Filter 0,459m HYdroPhilic
7,6-8,2
Formula
Berat molekul
Etanol 96%
L32,05 g/mol
800 - 10OO kg/m'
man/kebasaan
yo
CzHsOH
- 96,9 % (V /V)
S 30 ppm
Densitas
Residu penguaPan
0,805
Bacteria I endotoxins
S 2,5
Quantity/ Pak
Application
Fittins lnlet
96
-
0,812
325 mgll
l.U/ml
sample preParation for HPLC
Easv loading funnel
PENGADAAN REAGEN T.A 2015
Process volume (ml)
Pore size (;rm)
0,3 - 1,6
o,45
High density polyethylene
Material of contruction
wettability
16
lron Standard Solution
77
Kalium Arsenic
Hydrophilic
Diameter
25 (mm)
Tertelusur ke SRM dari NIST, Fe(NO:): dalam HNO3 0,5 mol/l, 1.000 mg/L
Fe
18
Kalium Periodate
19
Kertas Kromatogafi
20
Methanol
Synonims
Formula
Titik leleh
Potassium arsenate monobasic
Berat molekul
180,03
KHzAsOa
27t
- 28t C
Potassium periodate, periodic acid potassium
Synonims
Formula
KlOq
Assay
> 99,8
Berat molekul
230,00
Titik leleh
Halogen lain
Mn
s o,ot
sat
yo
s82c
%
Slppm
20x20 cm, untuk uji Kualitatif Kromatografi kertas, grade 1, 1 box isi 100
lembar
LC
grade
> gg,g
Assay
yo
Acidity
21
Mercury/ Hg Standard
solution
22
N-Butylamine
< 0,0002 meq/g
Alkalinity
< 0,0002 meq/g
Kadar Air
99,O%
Berat molekul
72,r5
-130 0C
0,6 glml
Densitas
Pe psi n
1
Assay
Titik leleh
24
-
Synonims
Formula
Pepsin
pH
from porane gastric mucosa
value
density
bulk
4,0 - 5,0
380 - 420 kg/m'
PENGADAAN REAGEN T.A 2015
solubility
25
pH Universal lndicator 0
-
Phospat Buffer Saline
27
Qualitative filter paper
29
30
31
pH indikator range
O
-
1.4
26
28
e/L (20
1,4, dengan bentuk strip
1.O
grade4, d=110mm
Qualitative filter paper
grade42,d=110mm
Qua litative filter paper
grade54O, d=L10mm
Qualitative filter paper
gradel, d=1LOmm
Qualitative filter paper
grade41, d=L10mm
@ 150 ml, 10x consentrate of pBS
Pack
of 110
Circles,
Pack
of
di.r.t"i
11,0
Circles, diameter 110 mm
Pack of 110
Circles, diu,
Pack of 110
Ltrcles, diameter 110 mm
Pack
of 110
32
Silica gel granule
33
silika gel 60 F254 TLC
Alumunium Sheet
(20x2o)
34
silika gel 60 F254 50 TLC
Alumunium Sheet
(10x20)
TLC Silica gel 60 F 254, ukuran 1,0 x 20 cm, pack SO/pack
35
Sodium 1-
5ynonims
Berat molekul
sodium 1-hexanesulfonate monohyd rate
206,24
Assay
>gg,a%
Molecular weight
Bentuk
1.42,04 g/mol
granul
pH
5,2-8
H
36
exa
n
su
lfon ate
Sodium sulfat a nhidrat
Warna Orange
Ukuran partikel 2-5 mm
massa molar 60,08 g/ml
bentuk padat, granule
Atumunium sheet 60 F 254,25 TLC plates 20 x 20 cm
bulk density
37
1400 kglm3
Mtembrane material polytetrafluorethylene
Syringe filter
Hydrophobic
PTFE
25 mm x 0,45 pm
Diameter pori
Lingkar luar
0,45 pm
25 mm
medical grade virgin polupropilene
< 50 prl (25 mm)
Housing
Rt Volume
Max operating
temperature
Max operating pressure
38
Syringe
filter Hydrophilic
PTFE
25 mm x 0,45
l-00oc
110 psi
Mem bra ne material polytetrafluorethylene
Application
um
Housing material
Diameter pori
Lingkar luar
Hold-up volume
Chromatography including LC, GC, HpLC, dan UHpLC
Dissolution testing
General particulate removal
HDPE
0,45 pm
25 mm
99,0%
Berat molekul
Densitas
490,69 g
/
C
mol
3
1,00 g/cm
pH
13
titik didih
100c
Manado, 13 Maret 2014
Mengetahul,
Komitmen
NlP, 19650829 199302 2 001
PENGADAAN REAGEN T.A 2015
SPESIFIKASI TEKNIS REAGEN
1
Acetonitril for
LC
ACN, methyl cyanide
Synonim
Massa molar
Densitas
Titik didih
Batasan ledakan
4L.05 g/mol
0.786 g/ml
81_.0 - 82,0 "C
3.0 - L7 o/o(V)
>_ 99,9 yo
Assay
2.
Ammonium chloride
Synonim
Sal ammoniac
Temperatur penyalaan
Kelarutan di dalam air
Titik leleh
Massa molar
>400 "c
372 e/l (20 "C)
335 "C (menyublim)
53.49 g/mol
L.52 g/cm3 (20 "C)
500 kglm3
4.5 - 5.5 (50 g/1, HzO, 20 "C)
Densitas
Bulk density
Angka pH
Tekanan uap
3
1-.3 hPa (30 "C)
Ammonium dihydrogen
phosphat
AmmoniunT biphosphate, Ammenium phosphote
Synonyms
monobasic, Primary ommonium phosphote,
M ono a m m o n i u m o'rtho ph o s p h ote
Formula
H6NOaP (NH4H2PO4)
Molekul
Assay
pH
Berat
Titik
4
Ammonium nitrate
leleh
3,8- 4,4 ( pada suhu > 20'C)
nitric acid ammonia
Synonims
Formula
NH+NOs
Assay
pH
4.5
>98%
-
6.0 ( pada suhu > 20"C
)
Synonims
169C
< 0,0005 % (< 5 ppm)
Toluena-4-asam sulfonat monohyd rate
For.mula
CH3C6H4SO:H.HzO
Titik nyala
Berat molekul
Titik didih
Kelarutan dalam
180C
L90,22 g/ml
Pb
5
>98%
19O
Titik leleh
Asam p-toluen Sulfonat
min 115,02 g/mol
air
t40c
67A
gll
PENGADAAN REAGEN T.A 201.5
Baku campuran Aflatoksin
Afla Test HPLC Kit
Benzalkonium Chloride
dalam
81 :82:G1 :G2 (1:0,3:1':0,3)dengan konsentrasi 2,6yglml
metanol
: G1 :G2
100 kolom dan l set standar baku campuran Aflatoksin BL : 82
alkylbenzyldimethyla m monium chloride
Synonims
Titik leleh
De
n
sita s
pH
40
0c
0,98 g/cm3
5-6
3)2
Cadmium standard
densitv
Synonims
Formula
Chloroform
Assay
Densita
s
L,O!3 glcm3 (2ooc)
Methylidyne trichloride, Trichloromethane
cHcl3
>99,8%
1,48 glmL at 25 "C(lit.)
Tertelusur pada SRM dari NIST dan
Dapar asetat (Buffer
in HNO3 0,5 mol/l, 1000 mg/L
PTB
Densltas
1,00 g/cm3
di-Ammonium HYdrogen
Synonims
ammonium phosphate
olprr
Rn rnonir* biphosphate,
Ammonlum
Phospat
dibasic
Solution Acetic Acid
PH
molekul
Bulk densitY
pH
Berat
Disodium hydrogen
Phosphate HePtahYd rate
Dodecylsulfat sodium
Salt
Na2HP04.7HzO
Berat molekul
pH
min 268,03 g/mol
8,7 -9,3
Densitas
1,68 g/cm3
Synonims
Formula
Lauryl sulfate sodium salt
PTFE
CrzHzsNaOaS
Titik leleh
min 288,37 g/mol
204 -207 c
Assay
> 99,0
Synonims
Formula
Ethyl alcohol
Assay
95,1
Keasa
Filter 0,459m HYdroPhilic
7,6-8,2
Formula
Berat molekul
Etanol 96%
L32,05 g/mol
800 - 10OO kg/m'
man/kebasaan
yo
CzHsOH
- 96,9 % (V /V)
S 30 ppm
Densitas
Residu penguaPan
0,805
Bacteria I endotoxins
S 2,5
Quantity/ Pak
Application
Fittins lnlet
96
-
0,812
325 mgll
l.U/ml
sample preParation for HPLC
Easv loading funnel
PENGADAAN REAGEN T.A 2015
Process volume (ml)
Pore size (;rm)
0,3 - 1,6
o,45
High density polyethylene
Material of contruction
wettability
16
lron Standard Solution
77
Kalium Arsenic
Hydrophilic
Diameter
25 (mm)
Tertelusur ke SRM dari NIST, Fe(NO:): dalam HNO3 0,5 mol/l, 1.000 mg/L
Fe
18
Kalium Periodate
19
Kertas Kromatogafi
20
Methanol
Synonims
Formula
Titik leleh
Potassium arsenate monobasic
Berat molekul
180,03
KHzAsOa
27t
- 28t C
Potassium periodate, periodic acid potassium
Synonims
Formula
KlOq
Assay
> 99,8
Berat molekul
230,00
Titik leleh
Halogen lain
Mn
s o,ot
sat
yo
s82c
%
Slppm
20x20 cm, untuk uji Kualitatif Kromatografi kertas, grade 1, 1 box isi 100
lembar
LC
grade
> gg,g
Assay
yo
Acidity
21
Mercury/ Hg Standard
solution
22
N-Butylamine
< 0,0002 meq/g
Alkalinity
< 0,0002 meq/g
Kadar Air
99,O%
Berat molekul
72,r5
-130 0C
0,6 glml
Densitas
Pe psi n
1
Assay
Titik leleh
24
-
Synonims
Formula
Pepsin
pH
from porane gastric mucosa
value
density
bulk
4,0 - 5,0
380 - 420 kg/m'
PENGADAAN REAGEN T.A 2015
solubility
25
pH Universal lndicator 0
-
Phospat Buffer Saline
27
Qualitative filter paper
29
30
31
pH indikator range
O
-
1.4
26
28
e/L (20
1,4, dengan bentuk strip
1.O
grade4, d=110mm
Qualitative filter paper
grade42,d=110mm
Qua litative filter paper
grade54O, d=L10mm
Qualitative filter paper
gradel, d=1LOmm
Qualitative filter paper
grade41, d=L10mm
@ 150 ml, 10x consentrate of pBS
Pack
of 110
Circles,
Pack
of
di.r.t"i
11,0
Circles, diameter 110 mm
Pack of 110
Circles, diu,
Pack of 110
Ltrcles, diameter 110 mm
Pack
of 110
32
Silica gel granule
33
silika gel 60 F254 TLC
Alumunium Sheet
(20x2o)
34
silika gel 60 F254 50 TLC
Alumunium Sheet
(10x20)
TLC Silica gel 60 F 254, ukuran 1,0 x 20 cm, pack SO/pack
35
Sodium 1-
5ynonims
Berat molekul
sodium 1-hexanesulfonate monohyd rate
206,24
Assay
>gg,a%
Molecular weight
Bentuk
1.42,04 g/mol
granul
pH
5,2-8
H
36
exa
n
su
lfon ate
Sodium sulfat a nhidrat
Warna Orange
Ukuran partikel 2-5 mm
massa molar 60,08 g/ml
bentuk padat, granule
Atumunium sheet 60 F 254,25 TLC plates 20 x 20 cm
bulk density
37
1400 kglm3
Mtembrane material polytetrafluorethylene
Syringe filter
Hydrophobic
PTFE
25 mm x 0,45 pm
Diameter pori
Lingkar luar
0,45 pm
25 mm
medical grade virgin polupropilene
< 50 prl (25 mm)
Housing
Rt Volume
Max operating
temperature
Max operating pressure
38
Syringe
filter Hydrophilic
PTFE
25 mm x 0,45
l-00oc
110 psi
Mem bra ne material polytetrafluorethylene
Application
um
Housing material
Diameter pori
Lingkar luar
Hold-up volume
Chromatography including LC, GC, HpLC, dan UHpLC
Dissolution testing
General particulate removal
HDPE
0,45 pm
25 mm
99,0%
Berat molekul
Densitas
490,69 g
/
C
mol
3
1,00 g/cm
pH
13
titik didih
100c
Manado, 13 Maret 2014
Mengetahul,
Komitmen
NlP, 19650829 199302 2 001
PENGADAAN REAGEN T.A 2015