Trace Metals Analysis in Pharmaceuticals

Medicilon’s process analytical sciences group provides support for research, development, and commercial production.

At Medicilon, the importance of analytical support in pharmaceutical development and manufacturing is well understood. We provide our clients with analytical method development and all other services required to support their regulatory needs.

Services Offered

• Analytical Method Development, Qualification and Validation For

  • Assay

  • Related Compounds

  • Water Content

  • Chiral Analysis

  • Residual Solvents

  • Trace Metals Analysis

• IPC and Release Testing

• Impurity Isolation and Structure Elucidation

• Reference Standard Qualification

• Stability Studies

• PGI Method Development, Validation and Testing

• Specification and Other Regulatory Filing Documentation Preparation

We have the following key instrumentation to support our analytical activities.

• Chromatography: UPLC, HPLC, LC-MS, GC, GC-HS

• Solid State Characterization: DSC, TGA, XRPD, PSD, Polarized Light Microscopy

• Elemental Analysis: ICP-OES

• Identification: NMR, FT-IR

• General Testing: KF, UV-Vis, Polarimeter

Medicilon’s scientists are highly skilled in the accurate quantification of trace metals in challenging matrices.  Our expertise in this area, combined with an array of modern technologies and detailed knowledge of regulatory issues in the pharmaceutical sector, makes Medicilon your ideal partner.

Trace Metals Analysis by ICPMS is also an excellent way to determine residual catalysts, such as palladium and platinum, in process intermediates and final

products. As an addition to trace metal analysis, we also offer full compendial API and excipient testing to the EP, BP, JP, and USP compendial.

In order to develop the best approach, the Metals Team begins by determining whether the application requires validated or non-validated methods. A fully validated approach may require multiple methods, depending on the material and metals. A critical step in determining the most appropriate analytical approach is to address the following key criteria:

• Define need for a general screening method vs. specific elements of interest

• Establish material specification limits as applicable

• Evaluate material solubility

The following table will help determine the instrumentation that best meets testing needs and provide general instrument performance guidelines, which may vary by method. For example, sensitivity limits are dependent on sample digestion approach, sample mass and instrument wavelength.

Trace Metals Analysis Methods

• Isotope analysis

• Quick sample throughput 

• ~1 to 0.001 ppb analytical detection limit range 

• Test trace and ultra trace analyte concentrations 

• Large number of sample analyses 

• Linear Range > 108 

• Quick turnaround time

• Method development increased time >

• Limited solids in sample 

• Potential element interferences 

• Requires > 5 mL sample

•ICP-OES

• Multiple element analysis (74 elements) 

• Quick sample throughput 

• ~100 to 0.1 ppb radial view analytical detection limit range 

• ~10 to 0.01 ppb axial view analytical detection limit range 

• Large number of sample analyses 

• Linear Range > 105 

• Quick turnaround time

Method development increased time 

• Potential element interferences 

• Requires > 5 mL sample

• Flame AA

• Short analysis time (~68 elements) 

•  ~100 to 1 ppb analytical detection limit range 

•  Large number of sample analyses 

•  Linear Range > 103 

•  Short method development time

• Single element analysis 

• Increased analyst testing time (cannot be left unattended) 

• Requires > 5 mL sample

•GFAA

• Increased sensitivity than Flame AA 

Multiple element analysis (>50 elements) 

~1 to 0.001 ppb analytical detection limit range 

Linear Range > 102 

Limited element interferences

• Single element analysis 

Increased analysis time than Flame AA 

Limited detection range 

Method development increased time 

Requires ~1 mL to 2 mL of sample

CVAA

• Greater sensitivity

Limited element interferences 

Quick analysis time

• Only applicable to Mercury

Trace Metals Analysis Applications

• Full Metals Screening – Quantitative and Qualitative

• Heavy Metals to USP 232/233

• Monograph Testing

• Drug Substance Testing

• Finished Product Testing

• Raw Materials Testing

• Stability Testing

• Container Closure and Packaging Testing

• Silicone Oil Leachables Testing

• Target Metals Analysis

• Metal Speciation

• Finish Product Release Testing

Email : marketing@medicilon.com
Tel : +86 021 58591500

Tips : Above is part of Trace Metals Analysis in Pharmaceuticals, trace metal analysis, metal analysis methods. You can also CONTACT US with any question or enquiry you may have. We will be happy to discuss your needs in detail and design an appropriate plan of action.