Isopropyl Myristate

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Isopropyl Myristate

Assay (GC method): Not less than 90.0%


[Kadar (metode KG: tidak kurang dari 90,0%]
System suitability solution:
[Larutan kesesuaian sistem]:
Transfer 25.0mg of Isopropyl Myristate Standard and 2.5mg of Isopropyl Palmitate Standard,
accurately weighed, to a 5-ml volumetric flask, dissolve in, dilute with n-hexane to volume,
and mix well.
[Pindahkan 25,0mg baku isopropil miristat dan 2,5mg isopropil palmitat, timbang secara
seksama, masukkan ke dalam labu ukur 5mL, larutkan dalam n-heksan sampai batas
volume, dan aduk rata].
Test solution:
[larutan uji]:
Transfer 50.0mg of sample, accurated weighed, to a 10-ml volumetric flask, dissolve in,
dilute with n-hexane to volume, and mix well.
[Transfer 50,0mg sampel, timbang secara saksama, ke dalam labu ukur 10ml, larutkan
didalamnya, encerkan dengan n-heksan sampai batas volume, dan aduk rata.]

Procedure:
[Prosedur]:
Apparatus: Gas Chromatography (GC) with Flame - Ionization Detector.
[Peralatan: Kromatografi gas (KG) dengan detektor ionisasi api (FID)]
Operational parameters:
[Parameter operasional]:
Column : Agilent J & W G27 Column HP-5 0.25µm (0.32mm ID x 30m)
[Kolom]
Inlet : Temperature = 240°C; Split ratio = 10 : 1
[“Inlet”] [Suhu = 240°C; “Split ratio” = 10 : 1
Column temperature : Initial Temp. Temp. ramp Final Temp. Hold Time at Final
programs (°C) (°C)/min (°C) Temp. (min)
[Program suhu [Suhu awal [Kenaikan suhu [Suhu akhir [Jeda waktu pada
kolom] (°C)] (°C/menit)] (°C)] suhu akhir
(menit)]
150 - 150 1
150 6 230 11
(Make adjustments if necessary)
[buat pengaturan bila diperlukan]
Carrier gas: Nitrogen, flow rate: 1.5ml/min.
[Gas pembawa: Nitrogen, laju alir : 1,5ml/menit].
Detector : Flame Ionization Detector
[Detektor] [Detektor ionisasi api]
Temperature = 280°C
[Suhu = 280°C]
H2 flow rate = 40ml/min
[Laju alir H2 = 40ml/menit]
Air flow rate = 450ml/min
[Laju alir udara = 450ml/menit]
Makeup N2 flow rate = 20ml/min
[Laju alir “Makeup N2” = 20ml/menit]

Inject about 2µl of Solvent (n-hexane), System suitability solution, and Test solution into GC.
[Injeksikan sekitar 2 µl pelarut (n-heksan), larutan kesesuaian sistem 1, dan larutan uji
ke dalam KG].

Chromatographic system:
[Sistem kromatografi]:
Chromatograph the System suitability solution, and record the peak responses as directed
for Procedure:
[Kromatografikan larutan kesesuaian sistem, dan rekam respon puncak seperti yang
diuraikan untuk prosedur]:
1) The Relative retention times for Isopropyl myristate and Isopropyl palmitate are 1.0 and
1.3, respectively.
[Waktu retensi relatif untuk isopropil miristat dan isopropil palmitat masing-masing
adalah 1,0 dan 1,3.]
2) The resolution, R, between Isopropyl myristate and Isopropyl palmitate peaks is not less
than 6.0.
[Resolusi, R, antara puncak isopropil miristat dan isopropil palmitat tidak kurang
dari 6,0].
3) The tailing factor for Isopropyl myristate peak is not more than 2.0.
[Faktor “tailing” untuk puncak isopropyl miristat tidak lebih dari 2,0].
4) The relative Standards Deviation (RSD) for 6 replicate injections is not more than 2.0%.
[Simpangan baku relatif (RSD) untuk 6 replikasi injeksi tidak lebih dari 2,0%].

Calculation:
[Perhitungan]:
Calculate the percentage of the Isopropyl Myristate (C 17H34O2) in the portion of test solution
taken:
[Hitung persentase isopropil Miristat (C17H34O2) dalam larutan uji dengan rumus]:

(rU/rT) × 100
in which:
[di mana];
rU is the peak response of isopropyl myristate.
[rU adalah respon puncak isopropil miristat].
rT is the sum of all the peaks.
[rT adalah jumlah keseluruhan puncak].

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