What are Extractables and Leachables?
Regulatory agencies have become increasingly rigorous with regards to the detection, identification...
Execution and Reporting of a Photostability Study Protocol
The protocol design, execution, and reporting of the confirmatory photostability for API and...
Alcami Announces Extended Workbench Offering for Analytical Services
Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical...
Bringing the Light to Photostability in Three Parts
Part 1: Basic Requirements – Setting the Stage
Antibiotic Potency Testing: Diffusion (Cylinder-Plate) Method
Both the European Pharmacopoeia and the US Pharmacopeial Convention (USP) require testing of...
Elemental Impurities USP: The Risk-Based Approach
The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods...
Overview and Performance of the Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics
Several agencies within the U.S. Federal government are focused on reducing the prescription drug...
Blog: The Effect of Abuse-Deterrent Formulations on Opioid Abuse
In 2011, the White House published “Epidemic: Responding to America's Prescription Drug Abuse...
Elemental Impurities: Updated Regulatory Requirements
In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for...
News: Enhanced Laboratory Services in Wilmington, NC Headquarters
Wilmington, NC – June 20, 2016 – Alcami, a leading provider of custom development and manufacturing...
News: Alcami Invests in MicroSEQ® Rapid Microbial Identification System to Expand its Service Capabilities
Wilmington, NC – May 12, 2016 – Alcami, a leading provider of custom development and manufacturing...