Bioanalytical Services

Bioanalytical Services:

  1. Small Molecules
  2. Large Molecules
  3. Discovery/Preclinical
  4. Controlled substances
  5. Biomarkers
  6. Assays

LC-MS/MS Capabilities
 
LC-MS is a valuable tool for the characterization of chemical degradants and impurities. By understanding the structures and sources of these related substances during early development, there is sufficient time to improve various processes, including API manufacturing, formulation and product process development. Depending upon the complexity of the molecule HDH Pharma may perform additional analyses, either because the number of potential related substances exceeds the number of peaks (multiple co-eluting peaks) or because reasonable structures cannot be proposed based on the collected data.

  1. Method development — whether you just have powder or a basic method
  2. Non-GLP discovery analyses — getting good results fast, for internal use
  3. Method validation consistent with EMEA and FDA guidances
  4. Method transfer capabilities — cloning your method to our lab without change, regardless of LC-MS platform in your lab
  5. High throughput regulated sample analyses for preclinical and clinical studies

The equipment base includes: 

Equipment and Facilities
 
All of our instruments are new or refurbished to factory specs from major manufactures, chosen for their ability to generate quality results. 
  1. API6500, API5500, API5000 API4000 and API3000 series with triple quard, and Q-trap systems
  2. Agilent 1100, 1200 series HPLC systems
  3. Agilent 5977A GC/MS, fitted with a 7697A headspace apparatus
  4. UV/Vis spectrophotometers
  5. FT/IR spectrometers
  6. Karl Fisher, Optical Roatation and Elemental Analysis
HDH Pahrma, Inc. is located in the heart of the Research Triangle Park life sciences cluster, along with biotechnology and pharmaceutical companies, academic research institutions and teaching hospitals. The facility is designed for translational development activities and is well-suited for the development of a wide range of compound types and safety classifications, ranging from parenterals for biotherapeutics to oral dosage forms for small and large molecules.

All environmental chambers including freezers, stability chambers and refrigerators are supplied with backup power utilizing a natural gas powered generator. Centralized oil-free compressed air has been plumbed to supply the nitrogen generators built by Sciex into the mass spec tables. Within the facility, a centralized nitrogen generator serves lines for routine sample evaporation under an inert atmosphere, thus minimizing the potential for air oxidation of all analytes. All lab areas are continuously video monitored to assure smooth, uninterrupted, safe and secure operations. Instruments are served by a secure central server for storing and protecting all experimental data.

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