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HPLC/MS

HPLC/MS/MS ANALYSIS

OF

PHARMACEUTICALS

&
METABOLITES

ROCKY MOUNTAIN INSTRUMENTAL LABORATORIES

(cGLP PHARMACEUTICAL ANALYSIS)

  • TANDEM MASS SPECTROMETRY - MASS SPECTROMETRY (MS/MS) minimizes interferences due to other substances in the matrix.
  • Tandem MS/MS/LIT offers a revolution in the ability to identify drug metabolites and degradants by combining HPLC with quadrupoles with a linear ion trap (LIT). Our SciEx API-4000 Q Trap can help us to detect metabolites which are undetectable by other technologies, even our other SciEx triple quadrupole mass spectrometers.
  • DRUG & METABOLITE RESIDUE MEASUREMENTS IN TISSUE SAMPLES including cotinine, drugs of abuse, therapeutic drugs, paclitaxel (Taxol), doxorubicin, vancomycin, rapamycin, everolimus, and other antibiotics and anti-metabolites.
  • PEPTIDE SEQUENCING & STRUCTURE ELUCIDATION & CONFIRMATION
  • FT/IR MICROSCOPY
  • QUANTITATION OF NON-VOLATILE OR LABILE DRUGS
  • EXTREME SENSITIVITY (pmol) SENSITIVITY FOR PHARMACEUTICALS
  • METABOLITE & DECOMPOSITION PRODUCT IDENTIFICATION
  • PEPTIDE, PROTEIN, & DEGRADANT ANALYSES
  • OLIGONUCLEOTIDE MOLECULAR WEIGHT AND CONCENTRATION DETERMINATION
  • DETECTION & IDENTIFICATION OF IMPURITIES IN OLIGONUCLEOTIDES
  • CLINICAL BIOSAMPLE ANALYSIS FOR DRUGS & METABOLITES
  • PROCESS OPTIMIZATION IN BIOREACTORS
  • FLAVORS & FRAGRANCES IN COSMETICS & FOODS
  • NATURAL PRODUCTS, TOXINS, NITROSAMINES, AND CARBOHYDRATES.
  • REVERSE ENGINEERING OF PRODUCTS
  • POLYMER CHARACTERIZATION
  • THERAPEUTIC DRUG MONITORING (SIROLIMUS, TAXOL, DOXORUBICIN, etc.)
Using our SciEx HPLC/MS/MS and HPLC/MS instruments with electrospray (ESI), NanoSpray, and atmospheric pressure chemical ionization (APCI) techniques, RML can solve many of your most difficult analytical problems, even ones which once seemed to be quite intractable. The detection of Tetracyclines in animal tissues, the analysis of cyclic peptides in whole blood, and the identification and quantitation of nucleotide and nucleoside analogues at sub-nanogram per milliliter levels are routine. HPLC/MS/MS is able to provide such excellent sensitivity both because of its great raw sensitivity and the improved Signal to Noise (S/N) ratio inherent in tandem mass spectrometry. MS/MS also can be coupled to capillary electrophoresis, providing greater sensitivity along with structure confirmation and degradant detection for peptides and proteins. We also offer GC/MS/MS for the analysis of drugs, synthetic contaminants, metabolites, and degradants.

HPLC/MS/MS and HPLC/MS can identify oxidation and reduction, phosphorylation, as well as deamidation and isoaspartate formation, in peptides, proteins, and small molecules.

The technique also can detect and identify synthetic impurities in oligonucleotides and provide information to support biotechnology CMC sections in new drug applications. Additional information regarding regulatory affairs can be found at: FDA, European Union, PDA (Parenteral Drug Association).

RML also offers FT/IR and other techniques for detection of protein pharmaceutical degradation. Such testing often can identify helix-coil transitions or other conformational changes in proteins. For a short discussion of HPLC/MS/MS, please access Mass Spectrometry. Additional information is available on other pages (Biopolymers and Drug Stability).

We also provide GC/MS/MS analysis of pharmaceuticals for the presence of volatile organics, the identification and quantitation of contaminants and raw materials. This includes the identification of small molecules, such as sugars and steroids, which require derivatization. For a list of some of our analyses, please see the Analyte List.

Please call Dr. Robert Lantz or Dr. Patricia Sulik regarding analysis of your product.

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Updated: 29 July 2010