(cGMP Stability Testing Meeting ICH Guidelines)
ICH Stability Testing is an integral part of Avomeen’s contract pharma services and supports clinical trials, IND, NDA, and aNDA applications. Our depth of knowledge and industry experience takes the stress out of completing regulatory submissions and post approval studies. Avomeen’s stability chambers are equiped with a back-up generator and are individually monitored/alarmed to insure that they maintain the proper environmental conditions including temperature, lighting, and humidity. We will help you develop a customized project that will meet your regulatory needs and can run projects under ICH, VICH, and specialized non-standard conditions.
Avomeen Offers cGMP Stability Testing for:
FDA-Registered, DEA-Licensed (Class I-V), cGMP-Compliant, and ISO 17025-Accredited
Pharmaceuticals & Medical Device Stability Testing:
Avomeen’s Stability Laboratory Can Answer Questions Including:
During the stability testing process our skilled chemists will take pulls at regular intervals over time in order to verify the samples are meeting their requirements according to their protocol. We utilize state-of-the-art instrumentation within our segmented laboratories which allows our chemists to perform elemental analyses, gas separation, liquid separation, microscopy, molecular characterization, to identify thermal/mechanical properties, and more. This type of testing develops crucial data on how pharmaceuticals and other products vary over time while under the influence of different environmental conditions including temperature, humidity, and photostability. This allows a products shelf life to be determined, as well as the establishment of recommendations on storage conditions and re-testing intervals.
Call on Avomeen’s experienced staff to perform FDA release testing for your products, including the following cGMP stability analyses:
Analytical stability programs for a drug substance or drug product can also be used for the characterization of impurities and degradations, in line with dissolution studies, and to determine the products hardness, its residual solvents, disintegration, and friability. Testing can be performed under ambient temperature, accelerated conditions, intermediate conditions, and long-term storage conditions.
Contact Avomeen to Arrange a Free Initial Consultation With One of Our Ph.D. Chemists