ROCKY MOUNTAIN INSTRUMENTAL LABORATORIES
(cGLP PHARMACEUTICAL ANALYSIS)
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.
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
QUANTITATION OF NON-VOLATILE OR LABILE
EXTREME SENSITIVITY (pmol) SENSITIVITY
METABOLITE & DECOMPOSITION PRODUCT
PEPTIDE, PROTEIN, & DEGRADANT ANALYSES
OLIGONUCLEOTIDE MOLECULAR WEIGHT AND CONCENTRATION DETERMINATION
DETECTION & IDENTIFICATION OF IMPURITIES
CLINICAL BIOSAMPLE ANALYSIS FOR DRUGS
PROCESS OPTIMIZATION IN BIOREACTORS
FLAVORS & FRAGRANCES IN COSMETICS
NATURAL PRODUCTS, TOXINS, NITROSAMINES,
REVERSE ENGINEERING OF PRODUCTS
THERAPEUTIC DRUG MONITORING (SIROLIMUS,
TAXOL, DOXORUBICIN, etc.)
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,
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
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
Please call Dr. Robert Lantz or Dr.
Patricia Sulik regarding analysis of your product.
ROCKY MOUNTAIN INSTRUMENTAL LABORATORIES,
108 CORONADO CT.
FT. COLLINS, CO 80525
LAST UPDATE: 17 APRIL 2012