I was recently enlightened by a friend who informed me of how modern day technology will completely eradicate waiting in line at the pharmacy. New York based Zipdrug delivers prescription drugs in an hour. Users can enter their prescription order, payment, and insurance information into Zipdrug’s mobile app. Zipdrug employees pick up the medicine and drop it off to the patient at their home. If you think that’s mind-blowing, wait until you hear about San Francisco, CA based QuiQui. They have the same mission but use drones to drop off your medications. Yes, drones.
It’s pretty clear that modern day technology is going to ensure fast, high-quality, and reliable prescription drug delivery service. Fortunately, this general trend towards modernization also extends to the process of ensuring drug safety and quality. The U.S. Pharmacopeial Convention (USP) sets drug (including food ingredients and dietary supplements) standards for products sold in the United States. These standards cover guidelines for drug identity, strength, quality, purity, packaging and labeling information.
In 2011, the USP launched the Monograph Modernization Initiative which would update existing monographs (written standards) and general chapters for drug substances, drug products and excipients. I recently had the opportunity to interview Dr. Jeffrey Rohrer, Director of Applications Development at Thermo Fisher Scientific based in Sunnyvale, CA about this initiative. Dr. Rohrer’s lab has developed IC applications for pharmaceutical products that are candidates to modernize methods in existing USP monographs.
Q: Why is the USP Monograph Modernization Initiative such a big deal?
A: Are we not in the 21st century? Modern times call for modern methods! Seriously, in my opinion this is about having more accurate, reliable, and safer procedures that are often faster. This initiative will ensure that modern assays are considered, validated, and approved for the analysis of pharmaceuticals. Older assays tend to use classical, wet chemistry procedures which are more labor intensive and expose chemists to hazardous reagents. Some older methods also lack specificity. Specific methods help reduce the problem of fraudulent pharmaceuticals.
Q: Based on your experience of developing IC methods, which types of analysis is IC used for?
A: Ion chromatography can be used for counterion determinations, measuring excipients in drug products, performing impurity analysis in drug substances and in some cases even assay of the drug substance.
Q: What are the unique benefits of IC for pharmaceutical analysis?
A: I’d say there are three key benefits. The first benefit is that you can simultaneously measure multiple ions in a single injection. For example, in Application Note 1090: IC Assay for Lithium, Sodium, and Calcium in Lithium Carbonate, we demonstrate the simultaneous determination of lithium, sodium, ammonium, potassium, magnesium and calcium using the Dionex IonPac¢ CS16 column.
The second benefit is derived from using a feature called automated Eluent Generation (EG¢) on Reagent-Free IC (RFIC¢) systems. RFIC systems elecytrolytically create mobile phases for the IC separation which improves both intra- and inter-lab reproducibility by eliminating errors associated with manual mobile phase preparation. For example, Application Note 164: Assay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chrom… describes a method which uses an electrolytic eluent generator to automatically produce an isocratic KOH eluent. The separation of phosphate and citrate is achieved in less than 10 minutes using a hydroxide selective Dionex¢ IonPac¢ AS11 column. A third but related benefit is the reduction in waste disposal costs because IC eluents do not contain hazardous organic solvents.
Q: Has IC been approved as a technique by the USP?
A: The USP does not actually approve techniques per say, but IC is an allowed technique for Identification Tests (USP General Chapter<191>), and is used for determining citrate and phosphate in drug products (USP General Chapter <345>) and for sialic acid monitoring (USP General Chapter <129>). IC is also used in a number of USP drug substance and drug product monographs.
Q: This was really informative. Just wondering¦.how do you feel about drones delivering medications?
A: Personally, I don’t want drones delivering anything.
If you are curious to learn more about using IC for pharmaceutical analysis, please register for an upcoming educational webcast on this very topic here. For a list of pharmaceutical applications, I’d recommend visiting a dedicated Pharma & Biopharma Learning Center. You’ll also be able to watch informative whiteboard videos on how IC works and the benefits of automated Eluent Generation in your free time. I’m sure you have plenty more now that drones will soon be dropping off all of our meds!