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Heavy Metal Testing

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Heavy Metal Testing

In daily life, various types of pharmaceuticals can meet people's needs for treatment or health care. However, in pharmaceutical development, the pharmaceutical may contain some heavy metals. The heavy metal impurities in the pharmaceutical will not only affect the stability of the pharmaceutical, but also cause certain harm to the user and affect the safety of the pharmaceutical. Therefore, in pharmaceutical analysis and testing, how to effectively test the heavy metals in pharmaceuticals is very important to protect human health. T,C&A Lab runs strictly in accordance with GMP and GLP standards to meet the relevant requirements of compliance, quality, efficiency, etc. We can test heavy metals according to US Pharmacopeia's Chapter <232> and <233>. Welcome to contact our experts for consultation.

Which products need to comply with the new regulations?

  • Finished medicine
  • Health products
  • Medical equipment
  • Excipients
  • Biological medicine
  • Active pharmaceutical ingredients (APIs)

Pharmaceuticals heavy metal detection items and limits

ElementsDaily Dose (μg/day)ElementsDaily Dose (μg/day)
Cadmium (Cd)5Rhodium (Rh)100
Mercury (Hg)10Ruthenium (Ru)100
Inorganic arsenic (As)15Chromium (Cr)250
Inorganic lead (Pd)15Molybdenum (Mo)250
Iridium (Ir)100Nickel (Ni)250
Osmium (Os)100Vanadium (V)250
Palladium (Pd)100Copper (Cu)2500
Platinum (Pt)100  

The highly toxic elements (As, Cd, Hg and Pb) are controlled at much lower levels than other analytes and must be detected in all samples.

Our testing methods include but are not limited to

Different pharmaceuticals require different detection methods, so the most appropriate detection method needs to be selected according to the pharmaceutical.

There are also burning detection methods for the detection of heavy metals. For example, when testing heavy metals in pharmaceuticals such as ethanol and dilute acid, because the solution cannot be directly configured, so the burning method is also a very important method. In this method, the sample is destroyed first, and the bound heavy metals are dissociated from it before detection.

Instruments and data

Heavy Metal Testing 1
Heavy Metal Testing 2
Heavy Metal Testing 3

Reference

  1. Suresh, K.; et al. Comprehensive Sampling and Sample Preparation. Analytical Techniques for Scientists. 2012 (3), 743-782.

Note: the service is for research use only and not intended for any clinical use.

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