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Analysis of Elemental Impurities in Pharmaceuticals: Trace Metal Identification & Control, Lecture notes of Biomedicine

The importance of analyzing elemental impurities in pharmaceuticals to ensure drug quality and patient safety. The sources of elemental impurities, regulatory guidelines, and analytical methods used for their detection. Cd formulation laboratory offers reliable and independent elemental impurities analysis services using various techniques such as icp-ms, icp-oes, ic, flaa, xrf, aas, and aes.

What you will learn

  • Which analytical methods are used for elemental impurities analysis in pharmaceuticals?
  • What are the regulatory guidelines for elemental impurities in pharmaceuticals?
  • What are the sources of elemental impurities in pharmaceuticals?

Typology: Lecture notes

2019/2020

Uploaded on 12/30/2021

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Elemental Impurities Analysis
The elemental impurities in drugs are trace metals that can be found in final products,
which may be harmful and must be controlled in the production process. The limits of
drug elemental impurities are determined by the regulatory agencies of the
corresponding countries/regions, such as the USP, ICH, Ph. Eur., ChP and JP. The
sources of elemental impurities include raw materials, production process, packaging
and container sealing system (CCS). They can interfere with the efficacy of drugs or
have a direct toxic effect on patients. Therefore, the elemental impurities analysis of
drugs is very important for drug quality control.
CD Formulation laboratory is cGMP-compliant and equipped with state of the art
analytical instruments. We have experienced analysis experts who can work with our
formulation and manufacturing team to provide you with drug elemental impurities
analysis services. Our elemental impurities analysis is performed in accordance with
pharmacopeia methods to give you reliable, independent data, which can help you to
make an appropriate risk assessment for your final drug products. In addition, we are
also able to develop and validate tailored methods of elemental impurities analysis
that will meet your specific needs.
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Elemental Impurities Analysis

The elemental impurities in drugs are trace metals that can be found in final products,

which may be harmful and must be controlled in the production process. The limits of

drug elemental impurities are determined by the regulatory agencies of the

corresponding countries/regions, such as the USP, ICH, Ph. Eur., ChP and JP. The

sources of elemental impurities include raw materials, production process, packaging

and container sealing system (CCS). They can interfere with the efficacy of drugs or

have a direct toxic effect on patients. Therefore, the elemental impurities analysis of

drugs is very important for drug quality control.

CD Formulation laboratory is cGMP-compliant and equipped with state of the art

analytical instruments. We have experienced analysis experts who can work with our

formulation and manufacturing team to provide you with drug elemental impurities

analysis services. Our elemental impurities analysis is performed in accordance with

pharmacopeia methods to give you reliable, independent data, which can help you to

make an appropriate risk assessment for your final drug products. In addition, we are

also able to develop and validate tailored methods of elemental impurities analysis

that will meet your specific needs.

Permitted Daily Exposures (PDE) for Elemental Impurities

A total of twenty-four elemental impurities are listed in the ICH Q3D guideline. The

PDE limits are shown in the table below:

Element Cd Pb As Hg Co V Ni Tl Au Pd Ir Os

Class 1 1 1 1 2A 2A 2A 2B 2B 2B 2B 2B

Oral PDE (μg/day)^5 5 15 30 50 100 200 8 100 100 100

Parenteral PDE (μg/day)

Inhalation PDE (μg/day)

Our Methods of Elemental Impurities Analysis

 Inductively Coupled Plasma – Mass Spectrometry (ICP-MS)

 Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES)

 Ion Chromatography (IC)

 Flame Atomic Absorption Spectroscopy (FLAA)

 X-ray Fluorescence (XRF)

 Atomic Absorption Spectrometry (AAS)

 Atomic Emission Spectrometry (AES)