Eagle Australia – A Full Range of Analytical & Microbiological Testing

Did you know that Eagle Australia offers a full range of analytical and microbiological testing services for your compounded preparations?

For any testing requirements which are not offered in Sydney, your samples are shipped to our Houston lab at no additional cost to you.

The combination of services we provide in our two locations enable us to deliver a complete array of testing solutions for active pharmaceutical ingredients and compounded preparations in various dosage forms (see below).

Choose Eagle Australia as your contract laboratory, and you can rest assured that you have the most comprehensive service at your disposal.

LOT RELEASE TESTING

Our Sydney laboratory offers the highest quality in potency testing, and in addition our Houston lab extends our testing capability by providing:

• Potency Testing on additional dosage forms and actives
• Rapid ScanRDI® Sterility Testing (Results in 2 business days after arrival at our Houston lab)
• USP <71> Sterility Testing
• USP <85> Bacterial Endotoxin Test
• USP <61> Microbial Enumeration
• USP <62> Objectionable Organisms
• USP <51> Anti-Microbial Effectiveness
• USP <788> Particulate Count
• USP <1207> Container-Closure Integrity
• USP <621> Chromatography
• USP <541> Titrimetry
• USP <191> Identification Tests – General
• USP <197> Spectroscopic Identification Tests
• USP <857> Ultraviolet-visible (UV) Spectroscopy Identification
• USP <791> pH
• USP <731> Loss on Drying (Lod)
• USP <921> Water Determination – Karl Fischer
• USP <643> Total Organic Carbon
• USP <232> Elemental Impurities
• USP <841> Specific Gravity
• USP <645> Water Conductivity
• USP <905> Uniformity of Dosage Units
• And many more….

Potency Testing METHODS AND DOSAGE FORMS

We perform potency tests by using state of the art instrumentation and our labs employ several technologies for testing potency including but not limited to: HPLC, UHPLC, IC, UV/VIS, and Titrations.  Purity measurements and stability studies are performed using technologies in which methods can be proven to be stability indicating (e.g., HPLC).  We offer testing for the following dosage forms:

Take heart knowing that your products are handled by industry experts who understand all requirements related to the testing of compounded preparations.

METHOD DEVELOPMENT AND VALIDATION

Eagle has a dedicated team of highly qualified scientists who develop and validate analytical methods based on ICH, TGA, and USP guidelines as well as high-quality industry practices.  We develop and validate assay methods as well as stability indicating methods developed specifically for our customer’s finished dose drug formulations.  We offer method development and validation services using a wide range of technologies including: HPLC, ICP-OES, IC, FTIR, and UV-VIS Spectrophotometry.  Our detailed validation reports include the following parameters, when applicable: Specificity, Linearity, Range, Accuracy, Precision, Limit of Detection, Limit of Quantitation, Forced Degradation, and Robustness.

STABILITY STUDIES

A stability study is an analytical process that provides evidence on how the concentration and quality of a drug substance or drug product varies over a given time under the influence of a variety of environmental factors, such as temperature, humidity, and light. To justify an extended beyond-use-date (BUD) for compounded preparations, a science-based stability program should be designed, with data collected and analyzed over the course of the study.

Eagle provides stability studies through our in-house R&D lab with industry experts including Ph.D. Chemists who have served the compounding world for decades.

CONTACT US TODAY

Contact us today and discover how you can begin working with our team of world-renowned experts who have provided scientific guidance to the compounding industry since 2003. For more information you can reach our team at: 02 9316 1500, or email us at info@pccarx.com.au