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Method Development Best Practices for New APIs
Developing a reliable analytical method for a new active pharmaceutical ingredient (API) requires careful planning, scientific expertise, and a structured approach from the earliest stages of research. Every decision made during development influences data quality and long-term manufacturing
Going, Going, Gone… Or Not?
When you send material to PTL for analysis, do you need your samples back? Perhaps they are difficult to produce, expensive, or highly proprietary. While we are always happy to send back any untested samples, we can’t always
Deciphering USP <788>: Particulate Matter in Injections
Within the pharmaceutical, health care, and numerous other industries, ensuring a product meets the quality standards outlined by the FDA is paramount to ensuring safety and efficacy. In the case of injectable products, the United States Pharmacopeia (USP)