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.
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
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.
Instrument | Advantages | Limitations |
ICP-MS | Multiple element analysis (74 elements) |
• 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
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.