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Technical principle and selection guide for drug trace oxygen analyzer
Date: 2025-12-12Read: 42
In the production of oxygen sensitive drugs such as injections, biological products, and freeze-dried powder injections, trace amounts of oxygen (usually at the ppm level) are key factors leading to API degradation, color changes, and even the generation of toxic impurities.Pharmaceutical trace oxygen analyzerTherefore, it has become the core equipment for verifying the sealing and stability of drug packaging.
There are three main principles of mainstream technology:
Electrochemical method: Oxygen undergoes a reduction reaction at the cathode of the sensor, generating a current signal. The advantages are low cost and portability; The disadvantages are short lifespan (6-12 months), susceptibility to temperature and humidity interference, and the need for frequent calibration.
Fluorescence quenching method: Based on the quenching effect of oxygen molecules on specific fluorescent dyes, the oxygen concentration is inferred by detecting changes in fluorescence lifetime. Non consumable, fast response, suitable for online monitoring, but the probe cost is relatively high.
Tunable diode laser absorption spectroscopy (TDLAS): Utilizing the characteristic absorption peak of oxygen in the near-infrared band, high selectivity and high precision measurement (up to 0.1 ppm) can be achieved. No need to touch the sample, supports non-destructive testing.
Key considerations for selection:
Detection limit and range: Injections usually require a detection lower limit of ≤ 1 ppm;
Sampling methods: puncture type (for penicillin bottles and ampoules), non-invasive type (through transparent packaging), or online circulation pool;
Compliance: compliance with regulatory requirements such as USP<1207>and EP 3.2.9;
Automation level: High throughput QC laboratories should choose systems with robotic arms and LIMS interfaces;
Maintenance cost: Although the laser method requires high initial investment, the long-term operation and maintenance cost is lower.
It is recommended that pharmaceutical companies conduct a comprehensive evaluation based on product risk level, testing frequency, and budget. For critical sterile products, priority should be given to using TDLAS or fluorescence method equipment to ensure data reliability and audit tracking capabilities.