Program Capabilities

The NMPL is an ISO/IEC 17025-accredited multi-disciplined drug based testing laboratory. The laboratory has a chemistry and microbiology section, each capable of testing for a wide range of chemical analytes and pathogenic/non-pathogenic microorganisms, respectively. In addition to the scientific analyses performed by NMPL, the laboratory staff also support domestic and foreign pre-approval, surveillance, and for-cause inspections. NMPL’s microbiologists have analyzed numerous parenteral drug products and have uncovered sterile products that were contaminated with various types of bacteria and/or fungi as well as identified drugs containing endotoxins. They have worked on many high-profile cases and have supported the Office of Criminal Investigations (OCI).

Specialized Capabilities

Microbiology

NMPL has a state-of-the-art Class 100 (ISO 5) Bio Clean Room Suite that consists of a gowning room, three analytical rooms, a unidirectional double-door autoclave, and a HEPA filtered pass-through. The Bio Clean Room Suite has a wide range of capabilities for sterility analysis on a variety of products (e.g., parenteral [injectable] drugs including antibiotics and biologicals; sterile ophthalmic preparations; sterile creams, ointments, and gels; medical devices; large- and small-volume (LVP and SVP) parenteral solutions), and other high priority products. Other Microbiological tests include: Microbiological Examination of Non-Sterile Products (Microbial Limits Test), Microbial Enumeration Test, Tests for Specified Microorganisms, Antimicrobial (Preservative) Effectiveness Test, Bacterial Endotoxin Testing, Environmental Sample Analysis, Microbiological Enumeration Tests for Nutritional and Dietary Supplements, Bioburden Tests, Particulate Matter Analysis, Genetic Sequencing, 16S rDNA Sequencing Container Closure Integrity Test (Leak Test) on LVP, SVP, ampules and vials.

Chemistry

This is a general-purpose chemistry lab dedicated to the analysis of various types of pharmaceutical products including tablets, capsules, gel-caps, liquids, suspensions, patches, combination products, sprays, etc.Lab capabilities include technologies such as HPLC, UPLC, UPLC/MS, mass spectroscopy, FTIR, FTIR-Raman, FTIR microscope, FTIR/GC, UV/VIS, GC/FID, GC/MSD, GC headspace, TGA, DSC, microscopy, dissolution, hardness testing, NMR, inhalants dose delivery testing (e.g., ACI/NGI/MDI), dye-ingress testing. These technologies allow our lab to use most USP methods to analyze pharmaceutical materials in addition to doing research within the NMPL lab.Our areas of expertise include the USP analysis of domestic drug products, imported drug products, screening of dietary supplements for contamination with drug substances, compounded drugs, USP CRADA (via a collaborative research agreement with USP), and consumer complaint samples. NMPL has acquired a Bruker Avance III HD 600 MHz NMR. This high-resolution instrument is capable of structural determinations, identification of unknown substances, reaction dynamics, and quantification for small organic molecules, inorganic complexes, and biomolecules. Its current project involves the detection and identification of over-sulfated chondroitin sulfate in heparin, but is used to support regulatory action, method development, and research throughout NMPL.