ANALYTICAL SERVICES

A laboratory at the intersection of communication and quality

Let the dedicated staff at Founders Science Group handle your analytical needs. From receipt of your sample to providing you with the finished report, our team has one focus: Quality. We provide a wide-range of industry standard testing and can also transfer in existing methods for client specific needs or work with your team to develop, validate and execute new methods.

Our clients come in all types: from established facilities looking for additional analytical support to virtual companies without access to their own laboratories.  If there is an analytical service that you do not see listed, please contact us. We are always bringing new equipment online and validating new methods for our clients.

USP TESTING & WET CHEMISTRY

While requests for USP testing are commonplace, we also can test to other regulatory governing bodies e.g. BP, EPA, JP. Below is a selection of tests that we provide at our facility.

Elemental Impurities USP<232><233>

Equipped with an ICP-OES, our lab will tackle your analytical needs for elemental impurities.

Spectroscopy USP<197>

With an extensive background of spectrophotometric testing, our lab can handle the standard FTIR methods <197K>, <197M>, <197F> as well as analysis via UATR attachment per <197E> and analysis via UV-VIS for <197U>.

Penetrability USP<381>

Let FSG help you comply with functionality testing for elastomeric closures. Being developed as new chapters in the USP, <382>, <1381>, <1382>, functionality testing for elastomeric closures is coming under increased scrutiny by the FDA.

Titrations USP<541>

Our staff has extensive experience in both conventional wet chemistry techniques and automated titration methods. Automatic titration using potentiometric, dE/dV endpoint can eliminate the need for visual endpoint determinations.

FSG can also develop titration methods for the expedient release of in-process materials reducing the time it takes to get drug product out the door.

Total Organic Carbon USP<643>

FSG is ready to provide TOC analysis whether you require testing of a single sample or validation for your cleaning program or water system.

 Osmolality USP<785>

Using our Fiske One Ten Osmometer, let our lab provide you with reliable osmolality measurements. Our equipment utilizes freezing point depression and requires a minimal amount of sample per determination.

Specific Gravity USP<841>

We can support your specific gravity needs whether you require testing via Method I or Method II—Our specific gravity determinations can be made via traditional means utilizing calibrated pycnometers or via automatic instrumental techniques with our calibrated density meter.

Viscosity USP<912>

Determinations are performed using Brookfield viscometers.  Stocked with various spindles and a helipath attachment for shear thinning formulations, FSG can evaluate materials across a wide viscosity range

Water Determination USP<921>

Providing analysis according to Method Ia, Direct Titration, FSG can support your titrimetric needs with analysis performed via Volumetric Karl Fischer Automatic Titration.

Water Testing

In addition to USP<643> and USP<785>, we can also perform the following water analysis:

  • Hardness ASTM D1126-02
  • Nitrate EPA 353.2 (for water quality)
  • Turbidity USP<855> (for water quality)
  • Conductivity USP<645>
  • pH USP<791>

FSG provides standardized water testing for the Pharmaceutical industry.  If you are looking for residential/well water testing, you can visit the MassDEP website for more information: MassDEP Drinking & Well Water Information.  MassDEP also has a list of cost-effective, certified laboratories for this testing, which can be found here: MassDEP Certified Laboratories.

METHOD DEVELOPMENT & VALIDATION

The HPLC experts at Founders Science Group are ready to bring decades of experience to your project. Our laboratory is equipped with new, state-of-the-art Agilent HPLCs and we are experienced with both reverse phase and normal phase development techniques. Don’t have what you need? We’ll make sure that we identify the appropriate accessories and bring them into service to meet your timeline.

 

Our team of experienced chemists are equipped with the knowledge to make your development work a success.  We keep in mind that methods need to be production-environment friendly, which means ease of use is key.  Optimization of your method includes:

  • Faster analysis time versus compendial methods.
  • Reduced consumable consumption (less waste)
  • More efficient and robust sample preparation and handling to reduce consumables used and lower your costs.
  • Improve analysis conditions to increase robustness.

With our attention to detail, development of your method will focus on improving the key parameters of validation: accuracy, linearity, precision, robustness and specificity without compromising detection (DL) and quantitation (QL) limits.

FINISHED PRODUCT SUPPORT

Founders Science Group provides the following services for our clients, all which are performed to the appropriate regulatory standards and/or per client’s specifications.

PRODUCT INVESTIGATION

There may be no topic that requires more experience than product investigations. Combining a step by step process-oriented approach, the staff at FSG can determine the root cause of an Out of Specification or Out of Trend, or when necessary, can serve as an independent outside investigator and make recommendations for Corrective and Preventative Actions.  Regardless of formulation type or the manufacturing process used, we can help to address critical issues or improve the process to reduce the total number of product complaints received.

PRODUCT PERFORMANCE & THE “PAWS”

Founders Science Group can assess performance testing on an array of packaging presentations with a focus on topical products in aerosols, airless pumps, jars and lotion pumps.  We can evaluate most parameters that may be critical to your product performance and organization or help identify critical characteristics to ensure quality finished products.

Founders has recently expanded capacity to meet new regulatory expectations regarding packaging for pharmaceutical use.  Our Product Actuation and Weighing Station, or PAWS, was developed with these new guidances in mind–the PAWS allows us to measure dispensing behavior, particularly for aerosols and airless pumps.  With this device we are able to collect data on:

  • Force required per actuation
  • Analysis of dosing (weight dispensed per actuation)
  • Number of pumps until the unit is primed
  • Number of pumps until the unit is empty
CALIBRATION AND MAPPING

Using equipment with NIST-traceability, Founders Science Group offers calibration and mapping for environmental chambers, freezers, refrigerators and other temperature and/or humidity controlling equipment. As part of this service, we work with the client to generate specific protocols to address your needs while considerate to industry-standard processes. We travel on-site for a pre-execution evaluation of the equipment to ensure that the protocols developed are appropriate for satisfying the desired objective. Upon completion of the service, we will provide your quality organization with a report and data packet capturing all actions performed.