(Kelso, Washington; November 10, 2010) - Columbia Analytical Services is pleased to announce its implementation of heavy metals testing that follows new recommendations released by the United States Pharmacopeia (USP). Columbia Analytical’s Pharmaceutical Division, a registered analytical laboratory providing current Good Manufacturing Practice (cGMP) compliant testing, abides by newly released instrumental methods guidelines for the detection of elemental impurities by Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS).

The USP recently proposed toxicological limits for elemental impurities to produce reliable data at detection levels that easily meet the elemental impurity limits. Experts at Columbia Analytical have extensive experience analyzing metals in a wide variety of matrices. Instrumental methods provided by Columbia Analytical accurately detect if metals meet or exceed those limits.

Columbia Analytical will be exhibiting at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, which will take place November 14-18, 2010, in New Orleans, Louisiana, at the Morial Convention Center, booth #2605.

“We are thrilled to join the thousands of scientists converging at the AAPS Annual Meeting this year, sharing their various perspectives and ideas, all with the goal in mind to improve overall health through advancing pharmaceutical sciences,” stated Jeff Grindstaff, Columbia Analytical laboratory director. “We are excited to showcase our capabilities, especially our wide-spread expertise in the detection of impurities in heavy metals.”

Columbia Analytical provides pharmaceutical testing and presents sound, accurate and reliable data, coupled with excellent customer service. In addition to its heavy metals testing, Columbia Analytical’s comprehensive range of capabilities includes monograph testing, method development and validation, engineering studies, process validation and stability testing.

About Columbia Analytical Services, Pharmaceutical Division
Columbia Analytical Services, Inc., Pharmaceutical Division is a registered contract testing laboratory providing cGMP-compliant testing to the raw material suppliers, CMOs, and product developers/sponsors of the pharmaceutical industry. To ensure regulatory compliance, Columbia Analytical is FDA inspected and registered, and DEA licensed. Columbia Analytical professional scientists have extensive experience in analytical chemistry and routinely provide method development and validation for pharmaceutical testing. For more information about Columbia Analytical Pharmaceutical Division, visit www.caspharma.com.

The CAS - Kelso laboratory is cGMP compliant and registered with the FDA. CAS’ comprehensive quality assurance and ethics programs ensure that data produced is scientifically sound, legally defensible, and accurately documented. To ensure that your analytical needs are met, your project is managed by one of our in-house project chemists. Our capabilities, expertise, and services include the following:

Monograph Testing – USP/NF, EP, JP, and BP monograph testing. This includes raw material and final product testing. An example of this includes Organic Volatile Impurities testing by USP <467>. CAS can also complete testing using client supplied methodology.

Method Development and Validation – Our professional scientists have extensive experience in analytical chemistry and can assist in method development and validation for pharmaceutical testing. Methods are validated to current ICH and USP guidelines.

Engineering Studies/Process Validation – Scientists at CAS are accustomed to non-routine testing and have the knowledge and resources to solve your analytical problems. Examples of this include analytical support for cleaning studies or manufacturing processes.

Stability Testing – CAS provides analytical support to your stability study testing. This may include assay testing, physical testing, and impurity and degradation product monitoring. This also includes development and validation of stability indicating assays.

CAS has extensive instrumental testing capabilities. CAS’ general analytical capabilities include the following: Karl Fischer, Gas Chromatography, Gas Chromatography/Mass Spectrometry, High- Performance Liquid Chromatography, Inductively Coupled Plasma/Mass Spectrometry, Inductively Coupled Plasma/ Atomic Emission Spectroscopy, Atomic Absorption, LC/MS/MS (currently being installed), and many general chemistry techniques.

Our services will help to keep your turn-around-times ahead of schedule, costs under budget, and most importantly meet cGMP quality and regulatory requirements.

Learn more about pharmaceutical testing…