Analytical Testing

  • Overview
  • Extractables and Leachables Testing
  • Oligonucleotide Analysis
  • Preclinical Support Services
  • Benefits of Analytical Testing
  • Why Work With NSF?
Scientists conducting analytical testing

NSF Health Sciences' pharmaceutical testing provides accurate, reliable, timely and cost-efficient contract analytical solutions. Our laboratory operates under full GLP and GMP compliance.

We are FDA registered and inspected and DEA licensed to handle, store and test controlled substances (Schedules I through V). NSF utilizes the following analytical technologies and techniques:

  • HS-GC/MS
  • ICP/MS
  • UV-Vis
  • FTIR
  • Osmolarity
  • Wet chemistry

Our services include:

  • Extractables and leachables testing for pharmaceutical packaging
  • Extractables and leachables testing for medical devices
  • Clinical and non-clinical bioanalysis
  • Oligonucleotide analysis
  • Biocompatibility testing
  • Toxicological risk assessments.

The NSF Health Sciences team is a key industry partner helping to solve some of the more complicated analytical challenges that companies face today. Our team is dedicated to establishing the trust, integrity and results required to build lasting client relationships.

For more information, contact us at or +1 860.940.6550.

Extractables and Leachables Testing

Extractables and leachables analysis can be determined for all types of pharmaceutical packaging, medical devices including combination and implant devices, single-use system components and manufacturing line components.

Volatile, semi-volatile, non-volatile and inorganic extractables and leachables can be released or migrate from drug product container closure systems, devices and manufacturing lines. It is an FDA requirement to identify and quantify these contaminants in drug products at release and on stability. Examples of these extractables and leachables include:

  • Monomers and plasticizers
  • Antioxidants and other additives
  • Coatings and mold release agents
  • Inks and adhesives

Our experts use the latest GC/MS, LC/MS/MS, LC/CAD and ICP/MS technologies to identify extractables and leachables. We develop and validate accurate and precise methods using HPLC, GC and ICP.

We monitor parameters such as, potency, pH, discoloration and degradation to determine extractable and leachable-induced changes that may adversely affect the quality of the product.

Oligonucleotide Analysis

NSF Health Sciences has extensive experience in methods development, validation and analysis of oligonucleotides and aptamers.

We develop stability indicating methods to analyze for parent compound, truncated species and metabolites using both HPLC/UV and HPLC/MS. We have provided plasma and tissue analysis for many pre-clinical and clinical oligonucleotide and aptamer studies. Our experience includes PEGylated and lipidated compounds.

Our key oligonucleotide services include:

  • Method development and validation
  • Analysis of animal and human biological samples
  • Stability indicating methods for parent, truncated species and metabolites
  • Complete pre-clinical and clinical program support

Preclinical Support Services

Study Design, Consultation and Monitoring

We provide expert toxicology solutions through consultation, study design testing and site monitoring to ensure a seamless transition of projects through IND-enabling studies and into clinical trials.

Our services also include complete toxicological risk assessment, including DEREK analysis as needed, to provide a comprehensive report that is directly suitable for regulatory submission.

Bioanalytical Methods Development, Validation and Sample Analysis

We provide bioanalytical methods development, validation and sample analysis in our FDA-GLP registered facility in Bristol, CT.

We support all types of preclinical studies from early discovery (ADME, PK, TK) through long-term chronic in all species. The NSF bioanalysis group has many years of methods development experience in complex matrices such as brain, spleen, spinal cord and vaginal tissue, in addition to the traditional matrices of blood, plasma and urine.

Sample data is processed and reported using Watson LIMS software. All reports are delivered as “ready to file” documents. We also offer full API characterization as well as formulation concentration and stability analysis.

Preclinical Study Design, Support and Monitoring

  • Complete design and support for IND-enabling study package
  • Site auditing and monitoring
  • Formulation development and analysis
  • Toxicology and pharmacokinetic reporting

Clinical and Preclinical Bioanalysis

  • Method development and validation
  • Plasma, blood, serum, synovial fluid, urine and feces
  • Tissues: Liver, kidney, spleen, brain, spinal cord, heart, eye, muscle, dermis
  • Species: Non-human primate, rodent, canine, porcine, bovine and human
  • Validation according to FDA guidance

Sample Analysis

  • Small and large molecules, oligonucleotides and aptamers
  • Liquid-liquid extraction, solid phase extraction, protein precipitation, digestion
  • UPLC/MS/MS, Waters UNIFI software
  • Watson LIMS

Benefits of Analytical Testing

Analytical testing equipment and scientist

Pharmaceutical Packaging

Well-documented incidents of contaminants leaching from containers and packaging have brought heightened awareness of the health risks posed by extractables and leachables in the manufacture of pharmaceutical container systems and product packaging.  NSF Health Sciences helps manufacturers evaluate packaging early in the drug development process to avoid costly delays in delivery of the finished product. We can evaluate:

  • Orally inhaled and nasal products (OINDP)
  • Parenteral and ophthalmic drug products (PODP)
  • Pre-filled syringes
  • Infusion bags
  • Tubes (creams and ointments)
  • Bottles, vials and stoppers

Single-Use Systems and Manufacturing Equipment

The disposable biomanufacturing industry has grown exponentially and continues to revolutionize how biotherapeutics are manufactured. The last few years have seen a rapid shift in single-use systems. We provide best practices for extractables and leachables for single-use technology in biopharmaceutical manufacturing for products such as:

  • Reactor bags
  • Holding reservoirs
  • Filters
  • Tubing, transfer and filling lines
  • Valves
  • Connectors

Medical Devices

NSF Health Sciences’ expertise in extractables and leachables helps manufacturers of medical devices meet U.S. and global market access requirements for products such as:

  • Infusion pumps
  • Catheters
  • Implantables and drug-filled implantables
  • Transdermal delivery systems
  • Ocular implants
  • Mesh products (implanted or dermal)

Biocompatibility Testing

NSF Health Sciences partners with American Preclinical Services (APS) to provide custom biocompatibility testing, interventional and surgical large animal research, and toxicology and pathology services:

  • ISO 10993
  • USP Class VI (<87> and <88>)

Toxicological Risk Assessment

NSF Health Sciences develops clinical study methodologies with expertise in FDA, ICH, ISO, EMEA, Prop 65 and EPA guidelines. We can provide:

  • DEREK qSAR analysis
  • Expert risk assessment evaluation
  • Study design support

Why Work With NSF?

Analytical testing equipment

NSF’s competencies include:

  • Method development and validation
  • Extractables and leachables testing for pharmaceutical packaging and medical devices
  • Biocompatibility testing
  • Oligonucleotide analysis
  • Clinical and non-clinical bioanalysis
  • Stability testing
  • Toxicology risk assessments

Working with NSF Health Sciences brings you:

  • A focused business model allowing concentrated analytical efforts to manage complex challenges and provide a complete and compliant data package
  • Recognized in-house industry experts who provide unmatched subject matter expertise to mitigate any complications
  • Extensive laboratory capabilities in the United States
  • Capabilities to offer study design, testing, consulting, training and agency representation
  • Project management focused on keeping all stakeholders informed throughout the entire project lifecycle
  • A single point of contact to coordinate all activities

Our scientists and technical experts come from a diverse background of experiences gained in all sizes of pharma and biotech companies. Led by a highly qualified and experienced senior team, you can be confident in our abilities to bring the correct technical expert to the discussion faster than any of our competitors. We offer a full range of GMP and GLP analytical solutions.

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