Category: How It Works
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Importance of Cleaning Validation in Preventing Cross-Contamination
Let’s get the boring part out of the way first, then we can get to some chromatograms! Cleaning validation is demonstrating with objective evidence that a cleaning process can repeatably and reliably remove all traces of product and any cleaning agents from equipment after the manufacturer of the batch. The reason this is important is…
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Laboratory Error & Investigations
It is hard to believe, but every now and then people make mistakes. Analysts might not have had coffee in the morning or were up too late playing video games and make a mistake during laboratory testing. In the pharmaceutical industry, whenever out of specification (OOS) results are generated, there is a rigorous methodology utilized…
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Sampling & Testing
Last update: 25-Oct-2024. Peptide users should consider the effect of sample size on understanding overall safety profile of the product lot, especially as the community begins to pool funds to reduce the cost of testing to a nominal amount, often less than the cost of the vials themselves. Manufacturing Defects Happen Randomly All manufactured products…
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On Peptide Purity
Updated: 25-Oct-2024 While identity, quantity, and sterility are straightforward and critical, purity is not something that is being fully & correctly analyzed today and is providing a false sense of security to users in this space. In this article, we are going to explain why. What Users Think It Means When a user sees “99.58%…
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How to Read and Understand a Certificate of Analysis (COA)
Updated: 15-May-2024 WHAT IS A CERTIFICATE OF ANALYSIS? A certificate of analysis is a legal document from a laboratory that provides documented test results. TrustPointe Analytics provides certificates of analysis to confirm certain properties of the active compound in a particular sample, including things like identification and content. WHAT IS AN INDEPENDENT LABORATORY? An independent…
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Identification by Retention Time
Identification by Retention Time (RT) is one of the standard methods of identifying a drug per the United States Pharmacopeia. It relies on the uniqueness of a drug’s interaction with the stationary phase and mobile phase in HPLC testing. Like a snowflake, every molecule’s interaction with the HPLC system parameters will be unique to that…