기시법 자료에 대한 양식이나 예시자료(샘플)이 있을가요?
제조업체에서 받는 시험자료는 번역해서 제출해야하나요?
답변부탁드립니다 감사합니다^^
Cosmetic (2014-04-01 07:52)
안녕하세요
기시법 자료 샘플을 아래와 같이 알려드립니다. 아래의 예문은 아데노신을 가지고 예시를 알려드리는 것입니다.
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Assay
Weigh 0.4 mg of product and add this to 20 mL of mobile phase and go through ultrasonic extraction. To this solution, add mobile phase to 50 mL and this becomes test solution. Separately, weigh 20 mg of standard and add mobile phase to 100 mL. Take 4 mL of this solution and add mobile phase to 100 mL and this becomes standard solution. Take 10 μL of test solution and 10 μL of standard solution and go through testing according to LC method under the following condition to get peak areas AT and AS.
Amount of adenosine (C10H13N5O4 X Ar/As X 1/50 ) (㎎)
= Amount of standard adenosine (㎎)
Conditions
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Detector: UV spectro (measured wavelength 260 nm)
Column: Fill a stainless pipe (inner diameter 4.6 mm, length 15 cm) with 5 μm of
octadecylsilylized silica gel (used for liquid chromatograph)
Mobile phase: acetonitrile 10mM+ potassium dihydrogen phosphate = mixed solution (5:94)
Rate of flow: 0.8mL/minute
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Cosmetic (2014-04-01 07:52) 
