Spesifikasi Reagen 2015 REVISI KE 2

(1)

ADDENDUM

II

SPESIFIKASI TEKNIS REAGEN

1

Acetonitril for

LC Synonim Massa molar Densitas Titik didih

Batasan ledakan

Assay

ACN, methyl cyanide 4L.05 g/mol

0.786 g/ml 81_.0

-

82,0 "C 3.0 - L7 o/o(V)

>_ _99,9yo

2. Ammonium chloride Synonim

Temperatur penyalaan Kelarutan di dalam air Titik leleh

Massa molar Densitas Bulk density Angka pH Tekanan uap

Sal ammoniac

>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)

1-.3 hPa (30 "C)

3

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)

Berat

Molekul

min 115,02 g/mol

Assay

>98%

pH

3,8-

4,4 ( pada suhu > 20'C)

Titik

leleh

19O

4 Ammonium nitrate Synonims

Formula Assay pH

Titik leleh

Pb

nitric acid ammonia

NH+NOs

>98%

4.5

-

6.0 ( _{pada suhu > 20"C}₎

169C

< 0,0005 % (< 5 ppm) 5 Asam p-toluen Sulfonat Synonims

For.mula Titik nyala

Berat molekul Titik didih

Kelarutan dalam

air

67A

gll

Toluena-4-asam sulfonat monohyd rate

CH3C6H4SO:H.HzO

(2)

Baku campuran Aflatoksin

81

:82:G1

:G2

(1:0,3:1':0,3)dengan

konsentrasi

2,6yglml

dalam metanol

100 kolom dan

l

set standar baku campuran Aflatoksin BL : 82 : G1 :G2 Afla Test HPLC Kit

alkylbenzyldimethyla m monium chloride 40 0c

0,98 g/cm3

5-6

Synonims

Titik leleh De n sita s

pH Benzalkonium Chloride

3)2 in HNO3 0,5

mol/l,

1000 mg/L

densitv

L,O!3 glcm3 (2ooc)

Cadmium standard

Methylidyne trichloride, Trichloromethane cHcl3

>99,8%

1,48 glmL at 25 "C(lit.) Synonims

Formula

Assay Densita s

Chloroform

Tertelusur pada SRM dari NIST dan PTB

Densltas

1,00 g/cm3

Dapar asetat (Buffer Solution Acetic Acid PH

Synonims

Ammonlum olprr

dibasic

Berat

molekul

L32,05 g/mol Bulk

densitY

800

-

10OO kg/m'

pH

7,6-8,2

Rn

rnonir*

biphosphate, ammonium phosphate di-Ammonium HYdrogen

Phospat

Na2HP04.7HzO

min 268,03 g/mol 8,7

-9,3

1,68 g/cm3 Formula

Berat molekul

pH

Densitas Disodium hydrogen

Phosphate HePtahYd rate

Lauryl sulfate sodium salt CrzHzsNaOaS

min 288,37 g/mol

204

-207

c

> 99,0 yo

Synonims Formula Berat molekul Titik leleh

Assay

Dodecylsulfat sodium

Salt

Ethyl alcohol CzHsOH

95,1

-

96,9 % (V _/V)

S 30 ppm 0,805

-

0,812 325 mgll S 2,5 l.U/ml Synonims

Formula

Assay

Keasa man/kebasaan Densitas

Residu penguaPan

Bacteria I endotoxins Etanol 96%

96

for HPLC Quantity/ Pak

(3)

Process volume (ml)

Pore size (;rm)

Material of contruction

wettability

Diameter

0,3

-

1,6

o,45

High density polyethylene Hydrophilic

25 (mm)

16 lron Standard Solution Tertelusur ke SRM dari NIST, Fe(NO:): dalam HNO3 0,5

mol/l,

1.000 mg/L Fe

77 Kalium Arsenic Synonims

Formula

Titik leleh

Berat molekul

Potassium arsenate monobasic KHzAsOa

27t

-

28t C

180,03

18 Kalium Periodate Synonims

Formula

Assay

Berat molekul Titik leleh

Halogen lain

Mn

Potassium periodate, KlOq

> 99,8 yo

230,00

s82c

s

o,ot

%

Slppm

periodic acid potassium

sat

19 Kertas Kromatogafi

20x20

cm, untuk uji Kualitatif Kromatografi kertas, grade 1, 1 box isi 100

lembar

20 Methanol LC grade Assay

Acidity Alkalinity

Kadar Air

> gg,g yo < 0,0002 meq/g

< 0,0002 meq/g <0,o2%

21 Mercury/ Hg Standard

solution

Mercury standard solution terlacak pada SRM dari NIST Hg (NO:)z dalam

HNO3 10 %,tO0O mgll Hg

Densitas

min 1,054 g/cm3

22 N-Butylamine Synonims

Formula

Assay

Berat molekul Titik didih

Densitas

1

-

aminobutane CHg(CHz)gNHz

99,5 yo 73,1.4 76

-78

C

0,74 g/ml

23 n-pentana Assay

Berat molekul Titik leleh

Densitas

>99,O% 72,r5 -130 0C 0,6

glml

24 Pe psi n Pepsin from porane gastric mucosa

pH

value

4,0

-

5,0

(4)

solubility

1.O e/L (20

pH _{indikator range}_O

-

_1,4,_{dengan bentuk strip}

@ 150 ml, 10x consentrate of pBS

Pack of 110 Circles,

di.r.t"i

Pack of 11,0

Circles, diameter 110 mm

Pack of 110 Circles,

diu,

Pack of 110

25 pH _{Universal lndicator}₀

-

1.4

26 Phospat Buffer Saline

27 _Qualitative

filter

_paper grade4, d=110mm 28 _Qualitative

filter

paper

grade42,d=110mm

29 _Qualitative

filter

paper

grade54O, d=L10mm 30 _Qualitative

filter

paper

gradel,

_d=1LOmm 31 _Qualitative

filter

paper

grade41, d=L10mm

Ltrcles, diameter 110 mm

Pack of 110 Warna Orange

Ukuran partikel 2-5 mm massa molar 60,08 g/ml bentuk padat, granule 32 Silica gel granule

33 silika gel 60 F254 TLC Alumunium Sheet (20x2o)

Atumunium sheet 60 F 254,25 TLC plates 20 x 20 cm

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-H exa n su lfon ate

5ynonims Berat molekul

Assay

Molecular weight Bentuk

pH

bulk density

sodium 1-hexanesulfonate monohyd rate 206,24

>gg,a%

1.42,04 g/mol granul

5,2-8

1400 kglm3

36 _{Sodium sulfat}a nhidrat

37 Syringe filter Hydrophobic PTFE 25 mm x 0,45 pm

Max operating

temperature

l-00oc

Max operating pressure 110 psi

Mem bra ne material polytetrafluorethylene Mtembrane _{material polytetrafluorethylene} Diameter pori

Lingkar luar Housing

Rt Volume

Application

Housing material Diameter pori

0,45 pm 25 mm

medical grade virgin polupropilene

< ₅₀prl (25 mm)

Chromatography including LC, GC, HpLC, dan UHpLC

Dissolution testing

General particulate removal HDPE

0,45 pm

(5)

Filtration

Area

3,9 cm2

Process

volume

_{100 mL}

Max operating

temperature

45 oC Max operating

pressure

100 psi

Non-steril

39 Tetra-n-butyl

Ammonium Hydrogen Sulfat

Formula Berat molekul pH

Bulk density Titik leleh

CroH:zNOqS 339,54 g/mol

1,

-2

650 kglm3

158

-

174 C

40 Tetraheptyl Ammonium Bromide

Formula

Assay

Berat molekul

CzaHsoBrN >99,0% 490,69 g

/

mol

41 Tetrametil Ammonium Hidroksida solution 10%

Densitas pH titik didih

1,00 g/cm

13 100c

3

Manado, 13 Maret 2014

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