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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...