With years of experience testing excipients and a broad portfolio of analytical techniques, Alliance Technologies, a full service, FDA registered and audited contract laboratory with DEA licensing, is well equipped to identify or characterize pharmaceutical formulations when a problem arises, quality is at stake, or intellectual property is questioned. Applications involving pharmaceuticals have included NIR identification tests, TOC cleanout validation testing, microspectroscopy for contaminant ID, HPLC or GC assay of API, characterization of excipients, FTIR ID of actives, and more.
Changes to USP organic volatile impurities (OVI) resulted in the current specification on residual solvents – USP <467>. Having participated in the revision process for this specification, Alliance Technologies’ scientists have the expertise to assay your product for residual process solvents or other impurities whether you are seeking regulatory compliance, patent protection, or quality control data.
Contact Alliance Technologies for testing your pharmaceutical or nutraceutical formula. Alliance Technologies maintains an active GLP/cGMP quality system, assuring you that our pharmaceutical analysis is done correctly and documented for regulatory compliance.
Pharmaceutical Analysis Services Case Studies:
- Residual Solvents & Product Contamination For health and safety concerns and regulatory compliance, residual solvents found in pharmaceuticals, cosmetics, and other consumer goods must be controlled and identified. Alliance Technologies has helped a number of clients identify or quantify residual solvents in their products. Methyl methacrylate (MMA) has been banned in 39 states for its irritating and sensitizing effects and has been declared ...Read more >>
- Chemical Identification for … Patent Infringement Investigation An intellectual property firm working on a case of possible patent infringement provided “blind” samples of stucco to Alliance Technologies for compositional analysis. They provided no guidance on the patent claims or composition, asking Alliance simply to conduct comprehensive analysis and comparison within a specified budget. To resolve this IP case, Alliance: Reviewed typical stucco compositions ...Read more >>
- Product Deformulation & Reverse Engineering With years of experience testing many different kinds of products for chemical composition, Alliance Technologies is capable of assisting with product deformulation or reverse engineering. Finding and applying the right analytical method to your particular product is challenging and only a few laboratories are equipped to handle these kinds of requests. Case studies: A Fortune 100 computer and electronics ...Read more >>
For more information on our services or a technical consultation, contact Alliance. If you have already received a quote and would like to submit your sample, please fill out our online sample submission form.