Analytical Services

Particle Sciences employs a wide range of analytical services to tackle clients’ manufacturing and development challenges.

Analytical Method Development and Validation Services

A core strength of Particle Sciences is our ability to develop and validate methods to support even the most complex dosage forms. We routinely compile method validation packages that include complicated multi-step sample preparations, considering the recovery of active pharmaceutical ingredients (APIs), impurities, and/or the dissolution performance of your product.

Over the decades we have supported the development of hundreds of small and large molecules such as peptides, proteins and oligonucleotides. We work with a wide range of dosage forms in virtually every route of administration and indication. Our physical and chemical characterization labs are well-equipped and well-staffed to support these efforts.

Fully integrated project teams

Our analytical scientists are fully integrated into our project teams from the beginning allowing full visibility into our clients end goals and target product profiles. From this vantage point, the analytical team works with our formulation team to develop robust methods in a phase-appropriate manner as the project progresses.

Unrivaled expertise in complex dosage forms

Over the last five years we have executed over 50 GMP validation protocols for complex dosage forms.


Willingness to take on a wide variety of projects has allowed our chemists to build up a robust skill set to work with a range of products:

  • Small molecule APIs to biopharmaceuticals
  • Emulsions and nanosuspensions to elastomeric drug-eluting devices.

Integrated with formulation

Our method development and validation team works closely with our formulation teams to tailor methods to the desired end formulation.

Drug Release Testing Services

Particle Sciences provides a complete suite of drug release assays for various dosage forms, including injectable formulations, implantable devices, and ophthalmic drug products.

Our GMP/GLP facilities have a wide range of state-of-the-art instrumentation and experienced technical staff to perform in vitro method development, characterization, and routine and specialized drug release testing.

High-quality method development

A well-designed drug release method can accelerate formulation development by highlighting lead prototypes based on the desired release rate and a product’s critical quality attributes. Our analytical team can develop test methods from square one for a range of complex dosage forms, including IVRs, topical applications, and polymeric drug-eluting devices —from preliminary prototypes through commercial products.

Experience in drug release testing

We have been performing drug release testing to support client projects for over two decades.

Expertise in complex dosage forms

Over 80% of our drug release testing is performed on complex dosage forms. We have unique capabilities designed to meet the needs of virtually any route of administration, whether it be oral, implantable, parenteral, transdermal, etc.

Unique capabilities

Our scientists have access to a wide range of analytical equipment, from USP Apparatuses to non-compendial incubator shakers and in-house Flow-Through Cell Apparatus 4 for drug-device combination products.

Physical Characterization Services For Drug Products

Particle Sciences is a leader in physical characterization of drug products. We have been at the cutting edge of regulated solid state characterization for decades.

With growing frequency, regulators are requiring tight control over parameters such as particle or droplet size, viscoelastic properties, and the correlation of these properties to efficacy. Based on this understanding, Particle Sciences is positioned to address these regulatory challenges. Our facility operates under GLPs/GMPs, has highly potent API handling capabilities, and is FDA-registered and DEA-licensed for all schedules of controlled substances.

Well-equipped laboratory facilities

Particle Sciences’s physical characterization lab is a natural extension of our analytical capabilities. We support formulation development and monitor stability through particle size distribution (laser diffraction and dynamic light scattering), rheological analysis, and solid-state characterization. We have in-house expertise with HPLC, FTIR, DSC, TGA, LC/MS, Raman microscopy, and other methods that support evaluations of key properties such as crystallinity and solubility.

We are adept at working with complex dosage forms, ranging from intravitreal injectables to nanosuspensions to long-acting implantables. With decades of drug-device combination product development experience, we are uniquely positioned to perform mechanical property testing on products such as vaginal rings and subcutaneous implants.

Our data-driven approach allows us to develop a robust characterization plan for your product. Our experience with a broad range of APIs and drug products ensures that suitable methods are selected.

Additionally, to help control variations in raw materials that affect performance, our scientists can help:

  • Qualify suppliers
  • Develop and validate characterization methods

Integrated with formulation

Our physical characterization and formulation teams work together to support and expedite formulation development.

Unrivaled knowledge and expertise in particle size analysis

For decades, Particle Sciences has been at the forefront of regulated fine-particle and nanoparticle characterization.

Unique capabilities

Our equipment is extensive, including a XiGo Nanotools Acorn Area™, Malvern and Horiba particle size analyzers, a Brookfield viscometer, and state-of-the-art TA DHR rheometers, among others. We also have a wide breadth of techniques, such as FTIR spectroscopy, optical and Raman microscopy, and DSC/TGA.

Stability Indicating Method Development Services

Particle Sciences understands that detecting chemical, physical, or microbiological property changes in an active pharmaceutical ingredient (API) is crucial during drug development and commercialization. Our chemists have a comprehensive grasp of what comprises a robust method and strive to generate meaningful, accurate data to support your target product profile.

For over 20 years, we have been developing a wide range of dosage forms for nearly every route of administration. We have seen hundreds of small and large molecules, such as peptides, proteins, and oligonucleotides. As a result, we have built up a skill set and a knowledge base that only experience provides.

We can develop stability-indicating methods from inception and optimize client-provided methods’ performance to ensure compatibility with the developed formulation.

Fully integrated analytical services

At Particle Sciences, communication between the analytical services and formulation teams starts early in a project and occurs consistently as a project progresses, allowing us to develop methods that generate early prototype data and facilitate quicker and more streamlined product development.

We deliver methods suitable for downstream use as a project progresses toward later development stages. We aim to minimize the risk associated with any significant changes in methods that can make data comparison difficult, adding cost, time, and complexity to the product development cycle.

Our team ensures the delivery of accurate, high-quality analytical data and sound formulation characterization to support regulatory approval.

Unrivaled expertise in novel and complex dosage forms

Willingness to take on a wide variety of projects has allowed our chemists to build up a robust skill set to work with a range of products:

  • Small molecule APIs and biopharmaceuticals
  • Emulsions and nanosuspensions to elastomeric drug-eluting devices.

Development of validatable methods

Over the last five years, we have executed over 50 GMP validation protocols for complex dosage forms.

Wide range of analytical equipment

Our scientists have access to an array of chromatographic detectors such as PDA (photodiode array), to evaporative light scattering, refractive index, and mass spectrometry for a wide range of molecules.