Micro-source detection official website - drug quality research, impurity research, structural confirmation, biological drug analysis, methodological development and verification
Sodium bisulfite is a compound widely used in all walks of life, initially used as a reducing agent, bleaching agent and so on in the light industry, chemical synthesis and other fields, and later gradually used as an antioxidant and preservative in the pharmaceutical and food industries. In the pharmaceutical industry, sodium bisulfite is mainly added to injections, tablets, etc. as antioxidants.
In the pharmaceutical industry, impurities in raw materials have unpredictable hidden dangers to the quality of products, so the purity of raw materials often has higher requirements. At present, the industrial production of sodium bisulfite is generally based on wet process, that is, synthetic precipitation from supersaturated solution. In order to explore the possible impurities and sources in sodium bisulfite, the anions in the sample can be detected and analyzed by ion chromatography.
Ion chromatography has high sensitivity, simple operation, fast, accurate and reliable detection results, etc., and is more and more widely used in drug analysis and impurity identification. Micro source detection has advanced ion chromatograph Dionex ICS500+, and has developed a rapid detection scheme for a variety of anions in the anti-oxygen agent sodium bisulfite, under the following specific detection conditions:
Analysis conditions:
Instrument model: Thermo Fisher Scientific Dionex ICS5000+
Anion exchange column: Dionex AS17-CRFIC 4mm*250mm, 4um
Eluent: KOH solution
Detector: Reject conductivity detector
Rejection current: 40mA
Column temperature: 30 °C
Flow rate: 1mL/min
Injection volume: 25 μL
To prevent oxidation of the sulfites, a solution of acetaldehyde is used for protection. The linearity, system applicability, precision, quantitative limit and detection limit of each anion were investigated, and the sodium bisulfite produced by an enterprise was tested. After investigation, the linear correlation coefficients of each ion are greater than 0.999, the resolution is greater than 1.5, and the remaining indicators also meet the acceptable standards.
Figure 1 below is the spectrum of each anion in the control, each ion has a good degree of separation, Figure 2 is the sample detection spectrum, you can see the presence of acetaldehyde, sulfite, sulfate in the sample, no other anionic impurities.
Figure 1: Control ion chromatogram
Figure 2: Sample ion chromatogram