Analytical Methods

10
Feb
Concept For Compliance For Services On Virtual Screen

The Importance of Sampling Plans for Uniformity of Dosage Testing

Numerous health authorities have cited companies for inadequate sampling plans of finished drug products. A recent 483 issued to a finished drug‑product firm specifically mentions the firm’s lack of a scientifically sound statistical sampling plan during production of all strengths of its drug product.  The FDA also mentions that this firm uses content uniformity results […]

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06
Feb
Abstract Molecular Structure

Revisiting the “Novelty” of Novel Excipients

February 3, 2020 was the last day to comment on the Food and Drug Administration’s (FDA) notice in the Federal Register on the Novel Excipient Review Program Proposal; Request for Information and Comments (here), which we reported on in a previous blog post (here).  In this notice, the FDA had proposed a pilot program related […]

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05
Feb
Researcher adding liquid from test tube with fire symbol, warning sign, danger

The “Unwelcome Guest” Spares Metformin

Recently, FDA has posted (here) that Metformin, from several sources, tested by FDA showed that the levels of N-nitroso-dimethylamine (NDMA) in the drug are below the levels of detection (here).  Great news!  NDMA belongs to the nitrosamine family, and is one of the well-known animal carcinogens and a suspected human carcinogen.  The nitrosamines, including NDMA, […]

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28
May

USP Chapter Spectroscopy Identification Tests – Controlling Your Identities!

This post was co-authored by Thu Truong, J.D., Senior Associate, Science and Technology Group, and Ron George, Ph.D, Director, Science and Technology Group Prior to USP 42 – NF 37 (effective April 30, 2019), USP Chapter <197>, Spectroscopy Identification Tests, stated, “The IR absorption spectrum of a substance, compared with that obtained concomitantly for the […]

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03
Jan

ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation – A Step towards Modernizing to Current Standards and Technology?

Recently, the ICH has communicated the intention to develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures (here), where ultimately both documents may be combined into one document. This is welcome news as ICH Q2(R1) is long overdue for revision (current […]

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