Testing to the Chinese Pharmacopoeia 2025

As Western pharmaceutical companies increasingly target the ever-growing Chinese market, there is a growing demand for raw material and finished product testing in alignment with the Chinese Pharmacopoeia (ChP).  The latest edition became current in October 2025 and contains 159 new entries and 1101 revisions compared to the 2020 version. At Butterworth Laboratories, we possess extensive experience with this text and are well acquainted with its many and varied nuances.

Lost in Translation

The current edition of the ChP, the 12th, was released in 2025. However, an official English translation is yet to become available. It took around 3 years for an official translation of the ChP 2020 edition to be published, so it is likely to be some time yet before we see one. During this interim period, some of our clients adhere to the 11th edition (so test to the latest official English translation), while others create their own unofficial translation from the original Mandarin. It’s also feasible to obtain unofficial translations from third-party translation companies for specific monographs and general chapters. However, care needs to be taken when taking this route, as translation errors or interpretations may impact the analysis and, therefore, compliance, and all required information, such as reagent preparation and general texts, also needs to be translated.

Searching high and low

When using the ChP, the initial hurdle lies in locating the correct monograph. The text spans four volumes: the first focuses on traditional Chinese medicines, the second on active pharmaceutical ingredients (APIs), the third on biological products, and the fourth pertains to excipients. As an analytical chemistry company, our primary reference points are volumes 2 and 4. However, it’s worth noting that some materials can have monographs in both of these volumes, which are different or even two monographs in the same volume! While there is typically minimal difference between the monographs, confirmation is required to ensure the correct one is applied, depending on the substance’s origin and final use.

The devil is in the details

All pharmacopoeias exhibit distinct nuances and idiosyncrasies, and these are all too easy to miss without care and experience. For instance, the ChP defines ‘constant weight’ differently from the United States Pharmacopoeia (USP) and the European Pharmacopoeia (Ph. Eur.), so analysts need to be alert to such differences. The ChP also requires that gravimetric vessels be conditioned to a constant weight, which is not required in the Ph. Eur. and USP.

The same, only different

There is no formal harmonisation of the monographs in the ChP with other pharmacopoeias, although there are ongoing efforts to move in this direction. Many tests align closely, especially compared with the USP and the JP (Japanese Pharmacopoeia), although subtle differences often exist.

At Butterworth Laboratories, we have extensive experience testing a single material across multiple pharmacopoeias simultaneously. Our meticulous approach involves identifying tests that are identical across these compendia and those that diverge. By minimising redundant testing, we can optimise efficiency and control costs.

When working with ChP methods, it’s essential to exercise care. If you require testing using this compendium, please don’t hesitate to reach out. We’re here to assist you.