NEWS & EVENTS

Alcami Presenting Beyond Elemental Impurities: New Applications of ICP-MS Webinar

Join Alcami on December 9

You're invited to take part in a live webinar on Wednesday, December 9 from 11:00 am to 12:00 pm EST. During this webinar, scientific experts will highlight several newer applications of ICP-MS in the pharmaceutical industry that capitalize on the technique’s versatility outside of the scope of elemental impurities.
Sign Up Here

Topics: Events News & Events Webinars Elemental Impurities icp-ms

eBook: Elemental Impurities

The US Pharmacopeia (USP) retired the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> with an instrument-based approach on January 1, 2018. Though the existing wet chemistry methods have been in effect for nearly 100 years, the methods were non-specific and frequently failed to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients. 

Throughout this guidebook, Alcami scientists will discuss heavy metal regulations, moving to a risk-based approach, the role of risk assessment in the manufacturing process, goals and accountability, and agency-accepted testing and filing strategy for elemental impurities. 

Topics: Elemental Impurities Analytical Development White Paper / eBook

Agency-Accepted Testing and Filing Strategy for Elemental Impurities

The new elemental impurities regulations stress the importance of controlling all sources of elemental impurities in drug products. The regulations also impact all upcoming and current commercial drug products for human use. To comply with these regulations, it is critical to have an efficient, cost-effective, and agency-accepted approach.

Elemental impurities can contaminate or leach into a drug product from multiple sources (i.e. drug substance, excipients, water, equipment, and container closure systems), therefore, it is no longer acceptable to monitor the inlet raw materials only. A conservative risk-based approach is recommended, which should address all potential sources of elemental impurities. If it can be demonstrated that the elemental impurities present in the drug product are under control (less than the control threshold for three lots), then analysis at release is not needed. 

Topics: Regulatory Compliance Elemental Impurities Analytical Testing Analytical Development Blogs

ON-DEMAND WEBINAR: Elemental Impurities

Join Alcami and the Division of Pharmacy Professional Development at UW-Madison for a webinar: Successful Application of the New Elemental Impurities Regulation.

The recent changes to the elemental impurities regulation guidelines increase the level of control necessary in testing for heavy metals in pharmaceutical and biotherapeutic products. The use of inductively coupled plasma (ICP) instrumentation is considered the ideal method to determine elemental impurities present in drug products and raw materials. This approach has been proven to be accurate, sensitive, linear, and satisfactory to include in filing reports.

Topics: Regulatory Compliance Webinars Elemental Impurities

Elemental Impurities: The Risk-Based Approach

The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> by January 2018. Although the existing wet chemistry methods have been in effect for nearly 100 years, the methods are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients. The USP requires Plasma Spectrometry (ICP-MS or ICP-OES) as the technique to screen and/or accurately quantitate the presence of any elemental impurities of interest.  From a compliance perspective, the new guidance for elemental impurities (USP<232>and ICH Q3D) only applies to the drug product.  There are currently two strategies to meet the requirements for elemental impurities, with the first being a risk-based approach.

Topics: Regulatory Compliance Elemental Impurities

Elemental Impurities: Updated Regulatory Requirements

In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for Elemental Impurities, which replaced wet chemistry "heavy metals" limit test, such as USP <231>, with new analytical technology, specifically inductively coupled plasma (ICP) - based technologies, and mandated conformance to new and specific limits for individual elements. This action by the ICH triggered prompt reactions by the U.S. Food and Drug Administration (FDA), United States Pharmacopeia (USP) and European Pharmacopeia (EP) to harmonize with the ICH requirements.

Topics: Regulatory Compliance Elemental Impurities