Next Breath is a specialty company of Aptar Pharma and a full-service cGMP compliant laboratory located in Baltimore, Maryland. It specializes in analytical testing of a range of drug delivery systems from early stage to commercialization. It is also an intellectual leader in the field of inhalation and nasal spray development, testing, and regulatory strategy.
Industry interest in extractables and leachables testing has grown significantly in the last few years. And, on 19 October 2021, Next breath will host a live educational webinar on Extractables & Leachables for injectable formulations. The webinar has two timings one is at 1330 hrs IST, and the second is at 2000 hrs IST.
Next Breath webinar will include safety thresholds for injectable products
In this webinar, they will explain what studies need to be performed for FDA submissions, an integral part of the regulatory approval process. They will also address the current PQRI (Product Quality Research Institute) safety thresholds for injectable products.
The event will include the discussion on equipment pros and cons for the assessment and development of methods to analyze non-volatile (LC/UV/MS), semi-volatile (direct-inject GC/MS), and volatile (headspace GC/MS) compounds. The company will also share its expertise and capabilities in designing and executing E&L studies.