The Use of Ion Chromatography for Measuring Residual Ions in Drug Product

Aug 22 2019

Ion Chromatography (IC) is a liquid chromatographic method that’s used to separate and analyze ionic molecules. IC is a preferred method to analyze active pharmaceutical ingredients (APIs), excipients, degradation products, and/or impurities that contain inorganic and organic ions, polar substances, or chemically similar analytes. IC is becoming a more prevalent analytical tool in biopharma, and…

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Strategic Partnership Blog Series, Part 1: Benefits

Aug 20 2019

Why would I want to form a strategic partnership with a 3rd party lab? A long-standing client of mine from early in my career used to talk about two principles of a strong business relationship.  The first (with an obvious nod to Robert De Niro from Meet the Parents) was the “Circle of Trust”.  It’s…

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Key Tests and Equipment for Analytical E-Liquids Testing

Aug 16 2019

Small scale e-liquids manufacturers can sometimes have difficulty understanding the complex instrumentation and methods used for analytical testing. You may be wondering if you need to perform all of the analytical tests that are available or what exactly is required for compliance by different regulatory agencies. To help you understand some of the important methods…

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Pharma Formulation Services Blog Series, Part 2: Respect the Chemistry

Aug 15 2019

Sometimes you have no choice.  “You can have any color you want ‘so long as it is black.’”  “Ice cream sold here: vanilla.”  You get the idea. So it is with formulation.  A substance will demand certain treatment.  An API with the solubility of brick dust requires a dosage form to enhance solubility.  An API…

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FDA Issues Warning Letters for E-Liquid Products without Marketing Authorization

Aug 13 2019

On August 8, 2019, FDA issued warning letters for 44 flavored e-liquid and hookah tobacco products, notifying 4 companies that the cited products can’t be legally sold in the U.S. because they don’t have the required marketing authorization. In a recent press release about the enforcement of Electronic Nicotine Delivery System (ENDS) and hookah tobacco…

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Avomeen Hires New Biological Chemistry Project Director

Aug 8 2019

Khanh Ngo Courtney will help expand Avomeen’s large-molecule and protein therapeutics business Avomeen Analytical Services recently announced Khanh Ngo Courtney as its Biological Chemistry Project Director. Through this newly created position, Courtney will help grow Avomeen’s large-molecule and protein therapeutics business segment by partnering with biopharmaceutical clients who are navigating the large-molecule product development life…

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The Growing Need for Extractables & Leachables (E&L) Testing of Pharmaceutical Manufacturing Equipment

Aug 7 2019

As part of the drug approval process for the U.S. Food and Drug Administration (FDA), all drugs in development must undergo extractables & leachables (E&L) testing. In the past, the FDA emphasized oversight of E&L testing for drugs that came with both a high-risk route of administration and high risk of packaging and dosage form,…

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2019 FDA PMTA Guidance FAQs

Aug 6 2019

9 Common Questions About the FDA’s new PMTA Requirements With the new FDA PMTA guidance that was released in June 2019, we have received a myriad of questions regarding the guidance, regulatory pathways, and the testing required for a successful PMTA submission. So if you’re wondering about the FDA’s new PMTA requirements, here are the…

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USP 232/233 Elemental Impurities FAQs: Part 2

Jul 30 2019

New and existing NDAs and ANDAs for drug products are required to meet USP <232> and <233> for elemental impurities As of January 1, 2018, generic and branded drug products are required to meet FDA industry guidance regarding elemental impurities. The limits and procedures for the screening and quantification of potentially toxic metal impurities are…

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The Use of Bridging Studies in the PMTA

Jul 23 2019

In the initial PMTA guidance from the FDA published in August of 2016, no mention of bridging studies appeared in that version of the guidance. However, in the new the June 2019 final guidance for PMTA submissions, the FDA specifically refers to bridging studies. FDA widely mentions and accepts bridging studies for a wide range…

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