How to Identify Pharmaceutical Particulates and Residue

How to Identify Pharmaceutical Particulates and Residue

Image Credit: Jordi Labs

The regulatory compliance standards for modern pharmaceutical products are among the harshest in the world, demanding cutting-edge quality assurance and quality control procedures to ensure that dosage-form products are suitable for market circulation.

Among these procedures are analyzing the presence of residue and particulates and characterizing these contaminant elements to understand their genesis.

Identifying residues and particulates in pharmaceuticals is the first stage in determining the contaminant and removing the source of contamination.

Many analytical methods are used to determine impurities in dosage form pharmaceuticals, such as Fourier transform infrared (FTIR-) microscopy and scanning electron microscopy in combination with energy dispersive x-ray (SEM-EDX).

This article provides a detailed description of how each method is used for identifying and detecting residue and particulates in pharmaceuticals.

Outlining SEM-EDX for particulates and residue analysis

SEM-EDX is an effective microscopic technique employed to produce high-resolution 3D maps of the topography and elemental composition of a sample. This is acquired using a fine-tuned electron source that collides with the sample in high-vacuum conditions.

This energetic collision produces secondary and backscattered electronics, along with elementally characteristic x-rays. The strength of the reflected secondary electrons is commonly influenced by the sample’s surface topography.

Sensitive photo-detectors are utilized in an SEM-EDX microscope to gather both the emitted secondary electrons and x-rays to quantitatively produce complex imagery that shows the pharmaceutical sample’s physiochemical features.

With detection limits of between 1000 to 3000 parts per million (ppm) and magnifications of up to 50,000x, SEM-EDX can be employed to identify residue and particulates in both local impurities and broad phases.

Particulates and residue analysis with FTIR-microscopy

In FTIR-microscopy, the sample is isolated inside an interferometer supplied with a highly tuned source of infrared light. Incident IR waves are absorbed by the sample and the microscope captures the wavelength and intensity of this absorbed spectra to determine the functional groups existing in the sample.

Particulates and residue can be detected with this technique at very small localities, with a minimum IR spot size of 10 to 15 micrometers (µm).

Applying these techniques to pharmaceuticals

As a result of their high reliability and precision, these analytical techniques are crucial for pharmaceutical quality control and assurance. Scientists can identify physical and chemical differences at an extremely high resolution, enabling the characterization of contaminants using their unique elemental signatures.

The residues and particulates identified can then be employed to determine contamination sources in the production chain and eliminate the production of the same impurities in future batches.

As an example, Jordi Labs utilized FTIR-microscopy and SEM-EDX to recognize brown particles viewed in a bioreactor by employing their unique x-ray and infrared spectra.

Each technique established the main trace elements as nickel (Ni), oxygen (O), and iron (Fe) to quantitatively identify the contaminant as rust which demonstrated early degradation in the bioreactor.

Fluoropolymer gaskets and corroding metals are one of the main sources of residue and particulate contamination in pharmaceutical products. These sources lead to harmful small molecule substances being deposited into raw pharmaceutical ingredients.

These elements can produce serious health problems if they go undetected, and can lead to the loss of FDA approval.

Particulate and residue analysis with Jordi Labs

The analysis of particulate and residue contamination in pharmaceutical products is a specialism of Jordi Labs. The company offers a detailed service created to identify and detect contaminants in raw materials or end products to remove impurities from the supply chain and manufacturing process.

Contact Jordi Labs directly to talk to the team about a specific application.

About Jordi Labs

Jordi Labs provides the highest quality contract analytical services and polymer HPLC columns to some of the world’s leading consumer products, polymers, pharmaceutical and medical device manufacturers. Our team of PhD analytical chemists specialize in chemical identification. One of core competencies is Extractables & Leachables testing.

We are also worldwide leaders in;

  • Particulates & residue analysis
  • Good-bad comparisons
  • Method development/validation
  • Polymer analysis
  • Polymer failure

We also help companies from Fortune 500s to innovative startups with method development, preparative HPLC, training seminars, depositions and consulting. As a family company, we take pride in the production of all of our products and analytical service offerings. It is our goal to help our customers overcome their analytical challenges by providing excellent products and personal assistance from our highly-trained staff of PhD chemists


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Last updated: Oct 1, 2020 at 5:08 AM

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