Testing to the Chinese Pharmacopeia (ChP)

As Western pharmaceutical companies increasingly target the Chinese market, there is a growing demand for raw materials testing in accordance with the Chinese Pharmacopeia (ChP).  At Butterworth Laboratories, we possess extensive experience with this text and are well-acquainted with its nuances.

The current edition, the 11th, was released in July 2020.  However, the official English translation became available only in March 2023, resulting in a noticeable lag—similar to a delay with previous editions. During this interim period, some of our clients adhered to the 10th edition (based on the latest official translation), while others created their own unofficial translations.  Obtaining unofficial translations from third-party companies for specific monographs and general chapters is also possible.  However, care must be taken when taking this route, as translation errors may impact the analysis.  All required information, such as reagent preparation and general texts, must also be translated. New editions are released every five years, so we can expect a similar challenge in 2025 and will have to wait until the official English translation becomes available.

When using the ChP, the initial hurdle lies in locating the requisite monograph.  The ChP 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 may have monographs in both volumes!  While there is typically minimal divergence between these monographs, confirmation is required to ensure the correct one is applied, depending on the final use of the substance.

Each pharmacopoeia exhibits distinct nuances and idiosyncrasies.  For instance, the ChP defines ‘constant weight’ differently from the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph Eur), so analysts need to be alert to such differences.

One significant challenge in ChP testing arises from the difficulty of obtaining ChP reference materials.  Unfortunately, these materials are unavailable in the UK or Europe, and our attempts to establish contact with the ChP have proven unsuccessful.  Consequently, we use suitable alternatives and collaborate closely with our clients to ensure consensus regarding the reference materials that are used.

There is no formal harmonisation of monographs in the ChP with other pharmacopoeia; however, many tests are aligned, especially compared to the USP and JP (Japanese Pharmacopoeia).  However, subtle differences often exist.  We have extensive experience testing materials against the ChP, USP, European Pharmacopoeia (Ph Eur), and JP at Butterworth Laboratories.  We check and identify identical tests across these compendia to optimise efficiency and control costs.

All of which shows, that 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.

Tim Goddard – Laboratory Manager – General & Inorganic