Study on determination of polysorbate 20 in PEG - rhIFN - β -1a Injection
Author(s): SUN Ying, ZHAO Wencai, ZHANG Guimin
Pages: 399-400,411
Year: 2016 Issue: 7
Journal: Qilu Pharmaceutical Affairs
Keyword: RhIFN - β - 1a; Polysorbate 20; Determination; Spectrophotometry;
Abstract: Objective To establish an improved method for the determination of polysorbate 20 in Polyglycolated Re-combinant Human Interferon β - 1a(PEG - rhIFN - β - a)Injections. Methods The tested samples were reactead with chloroform and sulfur cyanogens cobalt ammonium,after standing at room temperature,the content of polysorbate 20 was de-termined by spectrophotometer at 620 nm wavelength. Results The results showed that the measured value of polysorbate 20 was consistent with the added value in the tested samples,the recovery was 98% ~ 102% and the RSD was less than 2. 0% . Conclusion The method was convenient,accurate,can be used to quantitative detect polysorbate 20 content in PEG- rhIFN - β - 1a Injection and other formulations.
Pages: 399-400,411
Year: 2016 Issue: 7
Journal: Qilu Pharmaceutical Affairs
Keyword: RhIFN - β - 1a; Polysorbate 20; Determination; Spectrophotometry;
Abstract: Objective To establish an improved method for the determination of polysorbate 20 in Polyglycolated Re-combinant Human Interferon β - 1a(PEG - rhIFN - β - a)Injections. Methods The tested samples were reactead with chloroform and sulfur cyanogens cobalt ammonium,after standing at room temperature,the content of polysorbate 20 was de-termined by spectrophotometer at 620 nm wavelength. Results The results showed that the measured value of polysorbate 20 was consistent with the added value in the tested samples,the recovery was 98% ~ 102% and the RSD was less than 2. 0% . Conclusion The method was convenient,accurate,can be used to quantitative detect polysorbate 20 content in PEG- rhIFN - β - 1a Injection and other formulations.
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