Q1/Q2 (Q3) Deformulation
Avomeen specializes in deformulation and can quickly provide thorough and exacting data.
Our talented staff have years of experience and know-how to isolate and identify all constituents of complex formulations. We have experience with component fractionation and separation tools and techniques such as micro-extraction, solid-phase extraction, crystallization, distillation, and pyrolysis, and our laboratories are fitted with a suite of instrumentation including a state-of-the-art mass spectrometry lab, and numerous chromatographic as well as solid state analysis tools.
The reasons our clients require deformulation are manifold:
- Comprehensive Q1/Q2(Q3) deformulation to produce a generic product that exactly matches a Reference Listed Drug
- To understand a competitive formulation
- To determine if patents have been infringed or trade secrets stolen
- To be able to modify a commercial product for a new market
Deformulation is as much an art as it is a science. Avomeen’s know-how spans a diverse spectrum of fractionation/separation techniques to render complex samples suitable for accurate analysis. Routine tools to fractionate and clean samples for analysis include liquid-liquid extraction, solid phase extraction, microtomy, chemical derivatization, and enzymatic treatment.
For critical applications such as prescription drugs, regulations mandate accuracy of no less than +/- 5% quantitation of each constituent in the formula.
Avomeen’s state of the art laboratories are equipped with a comprehensive array of analytical tools. High throughput analysis tools such as HPLC and Gas Chromatography (GC) are supported by multiple instruments. We have esoteric as well as common detection modes. For HPLC these include not only UV/Visible and Photodiode Array detection but also Pulsed Amperometric, Fluorescent, various Light Scattering modes, and mass spectrometric (MS). For GC these include not only Flame Ionization but also TID and TCD, Headspace, Pyrolysis, and MS. Avomeen’s MS capabilities in particular are exceptional.
For less routine analyses, we have a variety of tools and techniques that include dissolution testing equipment, thermometric analysis, and electron microscopy.
With recent expansion, Avomeen has brought online protein expertise and implemented Q-TOF, capillary electrophoresis, and other tools to deformulate in support of protein “biosimilar” products, diagnostic reagents, and other life sciences formulations.
Historical success stories include complete deformulation of solid, semi-solid, and liquid compositions, specialty coatings and adhesives, protein therapeutics, and in vitro diagnostic products.
With Avomeen’s other comprehensive pharmaceutical development services, we are your contract service provider of choice to bring through development novel and competitive pharmaceutical compositions.
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