RP-HPLC detection method for recombinant human granulocyte colony stimulating factors

RP-HPLC detection method for recombinant human granulocyte colony stimulating factors

The invention relates to a reversed-phase high-performance liquid chromatography (RP-HPLC) for recombinant human granulocyte colony stimulating factors. A Vydac C4 column is adopted in the method, acetonitrile gradient elution is performed, and the temperature of the column is 60+/-3 DEG C. The C4 c...

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Hauptverfasser: FANG JINGJIN, LI HUI, SHEN LING, CHEN HAIHONG, GUO WANGMING
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Sprache:chi ; eng
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INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
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creator FANG JINGJIN
LI HUI
SHEN LING
CHEN HAIHONG
GUO WANGMING
description The invention relates to a reversed-phase high-performance liquid chromatography (RP-HPLC) for recombinant human granulocyte colony stimulating factors. A Vydac C4 column is adopted in the method, acetonitrile gradient elution is performed, and the temperature of the column is 60+/-3 DEG C. The C4 column used by the method is different from a C18 column used in the 2010 version of Chinese pharmacopoeia, and the detection sensitivity and the accuracy are higher. Although the C4 column is adopted in European pharmacopoeia, but the acetonitrile gradient range used by the C4 column is small, and the separation time is long, so the new method can measure the stability of the recombinant human granulocyte colony stimulating factors under different storage conditions more quickly and more accurately. The detection analysis method for the recombinant human granulocyte colony stimulating factors recorded by the conventional pharmacopoeia is improved, so that the method is more suitable for purity detection of an rhG-C
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subjects INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
title RP-HPLC detection method for recombinant human granulocyte colony stimulating factors
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