Latest ArticlesWeight (filling) variation is an important critical quality attribute for pharmaceutical preparations, and is one of the critical aspects for the uniformity of dosage unit testing. In the ICH tripartite pharmacopoeias (USP, EP and JP), the harmonized general chapter on uniformity of dosage units (ICH Q4B Annex 6), utilizing a unified attribute and variable sampling plan. In General Requirements for Preparations of Chinese Pharmacopoeia, the Weight (Filling) Variation test has always used an attribute sampling plan, and there are differences with the Weight (Filling) Variation test in the ICH general chapter on uniformity of dosage units in terms of the preparation scope, sampling plan, and acceptance criteria. After the harmonization process with ICH Q4B, the newly added general chapter 〈0940 Uniformity of Dosage Units〉 was incorporated in Chinese Pharmacopoeia 2025 edition. In this paper, the harmonization consideration including the preparation scope, sampling plan and acceptance criteria was reviewed and interpreted in detail for Weight (Filling) Variation test described both in 〈General Requirements for Preparations〉 and in 〈0940 Uniformity of Dosage Units〉. The harmonization with ICH can further improve China's drug regulatory capacity and facilitate drug quality control to align with international standards.
The disintegration test is a critical method and means for controlling the critical quality attributes of solid dosage forms. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) harmonized the disintegration test methods of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP), resulting in the ICH Q4B Guideline Annex 5, which allows for mutual recognition within the ICH region. The 〈0921 Disintegration Test〉 in the 2025 edition of the Chinese Pharmacopoeia (ChP) has been harmonized with ICH Q4B Annex 5 (R1), achieving consistency with respect to apparatus and general procedure; acceptance criteria according to ICH and CHP are described in parallel; and the requirements for specific dosage forms as per the 2020 edition were retained. Additionally, the framework of 〈0921 Disintegration Test〉 has been revised to align with the ICH guideline, ensuring harmonization with international standards. This revision not only considers the historical inheritance of the Chinese Pharmacopoeia and the practical needs of China's pharmaceutical industry but also achieves international harmonization. This article provides a detailed comparison of the differences in apparatus and procedure between 〈0921 Disintegration Test〉 in the Chinese Pharmacopoeia and ICH Q4B Annex 5 (R1). Research on the harmonization of disintegration test methods across the ICH tripartite regions (EP, USP, JP) was carried out, including the comparison of disintegration test results, investigation of statistical data simulation for acceptance criteria, and the interpretation of the background, approach, and considerations behind the harmonization of 〈0921 Disintegration Test〉 with ICH. The aim is to enhance the understanding of the revisions to the 〈0921 Disintegration Test〉 in the 2025 edition and provide supportive reference for both the pharmaceutical industry and regulatory authorities.
Zongertinib is a novel human epidermal growth factor receptor 2 (HER2) selective tyrosine kinase inhibitor. In August 2025, zongertinib was approved by the US FDA for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain mutations and who have received prior systemic therapy. Clinical studies have shown that zongertinib has good efficacy and a manageable safety profile. Common adverse reactions of zongertinib include diarrhea, hepatotoxicity, and rash, etc.
The WHO launched the regulatory system strengthening program for medical products in 2014, aiming to encourage the enhancement of medical product regulatory levels in countries and promote the coordinated development of regulatory capabilities globally. This initiative encompasses guidelines on quality management systems, good regulatory practices, good trust practices, and a global regulatory capacity framework. Its core tools are the global benchmarking tool (GBT) for regulatory system assessment and the WHO-listed authorities (WLA) framework built upon the GBT. Understanding the assessment requirements of the GBT and WLA can not only provide ideas for improving China's drug regulatory system but also serve as a reference for aligning regulatory work with international standards. This paper systematically introduces the assessment dimensions and key requirements of the GBT and WLA in order to explore their intrinsic relationship with relevant guiding principles.
Patient-derived explants (PDEs) still lack a unified definition. Based on a comprehensive review of multiple studies, they are defined herein as "thin slices of tissue obtained from living tissues using tissue slicing techniques that retain cellular activity, intact tissue composition, and cellular distribution characteristics”. PDEs have been in existence for many years, but they have not yet been widely used in new drug research or clinical translational studies. Efforts to improve the culture system of PDEs and integrate more analytical techniques with the PDEs have enabled the detection of more markers using fewer tissues. As an undeconstructed ex vivo model, PDEs preserve the original tissue cell types, cellular distribution, and cellular activity and feature a high establishment rate and a short detection cycle, making them suitable for drug sensitivity testing and mechanism-related studies. In particular, they show great potential in tumour-related drug sensitivity assays and immunological studies. Therefore, PDEs represent powerful ex vivo models for disease research and new drug development.
Ion chromatography, an important branch of liquid chromatography, has been widely used in the field of analytical chemistry due to its advantages including rapidity, sensitivity, good selectivity, and the ability to simultaneously determine multiple components. This paper comprehensively summarizes the technical principles, development history, detection methods and pretreatment techniques of ion chromatography (IC), with emphasis on its application in pharmaceutical analysis, particularly in the quality control of aminoglycoside antibiotics, with the aim of providing a comprehensive summary for future research and application.
The rapid and sustained antidepressant effects of brexanolone and zuranolone represent a breakthrough in the treatment of postpartum depression (PPD) fueling in-depth research into the antidepressant mechanisms of gamma-aminobutyric acid type A receptor (GABAAR) modulators. This article systematically reviews 14 clinical trials, and evaluates the clinical advantages and potential limitations of brexanolone and zuranolone though post-hoc analysis, providing valuable insights for clinical application. Additionally, based on recent mechanistic studies of brexanolone and its analogs, three hypotheses are proposed to explain their rapid and lasting antidepressant effects: the neuroendocrine hypothesis, neural oscillation hypothesis, and neurotrophic factor hypothesis, offering novel directions for development of drugs for PPD.
To establish a qualitative analytical method for the chemical constituents in the root and vine of Actinidia chinensis Planch, and to systematically compare the similarities and differences between them.
LC-MS was performed in negative ion mode to acquire high-resolution mass-to-charge ratios and ion intensity data of the samples from the root and vine of Actinidia chinensis Planch. Principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were applied to the preprocessed dataset to rapidly identify differential components between the two samples.
The chemical compositions of root and vine were similar, primarily consisting of triterpenoids, flavonoids and phenylpropanoids, but with certain differences in content. Multivariate analysis identified 31 differential components. The root showed higher contents of triterpenoids (e.g., asiatic acid) and flavonoids (e.g., catechin) than the vine, while five differential compounds, including fraxin and aesculetin, were relatively more abundant in the vine.
This study clarifies the similarities and differences in chemical composition between the root and vine of Actinidia chinensis Planch. The admixture of vine into the root was found to compromise its quality. This study provides significant implications for ensuring the quality of root of Actinidia chinensis Planch., guiding clinical medication, and facilitating the medicinal development of both root and vine resources.
To establish a supercritical fluid chromatography (SFC) method for the determination of chiral purity of palonosetron hydrochloride using two columns in series, and to determine the isomers in palonosetron hydrochloride bulk drug and injections.
Two columns, DAICEL CHIRALPAK AD-3 (150 mm×3.0 mm, SFC, 3 μm) and DAICEL CHIRALPAK IG-3 (150 mm×3.0 mm, SFC, 3 μm), were in series. The column temperature was at 37 ℃, the mobile phase was composed of CO2 and a mixture of anhydrous ethanol, acetonitrile, and diethylamine at a ratio of 55∶45, the back pressure was at 12 MPa, the flow rate was 1.2 mL·min-1, the injection volume was 20 μL, and the detection wavelength was at 240 nm.
The R,S isomer, R,R enantiomer, S,R isomer, and palonosetron were eluted sequentially within 10 min with resolutions of 1.7, 2.3, and 1.5, respectively. All four compounds exhibited good linearity between peak area and concentration in the range from 0.20 to 10.0 μg·mL-1, with r all greater than 0.999 5. The detection limits (S/N=3) of the three isomers were all 0.10 μg·mL-1; and the quantitation limits (S/N=10) were all 0.20 μg·mL-1. The average recoveries of the three isomers in the bulk drug and injections ranged from 97.8% to 101.3%, with relative standard deviations (RSDs) ranged from 0.3% to 1.5% (n=9). Except for one batch of bulk drug in which no chiral impurity was detected, the R,S isomer was detected in all the other five batches, with contents ranging from 0.03% to 0.12%.
The developed SFC method can separate palonosetron and its three isomers in a short analysis time, and the use of two columns in series improves the separation efficiency, especially the resolution between the S,R isomer and palonosetron. The method is accurate, reliable, and can be used as an effective means for chiral purity determination and quality control of palonosetron hydrochloride bulk drug and related preparations.
To study the impurities in domestic piroxicam gel.
An HPLC method was established to study the impurities in piroxican gel. Waters XBridge C18 (250 mm×4.6 mm, 5 μm) column was used with gradient elution of mobile phase consisting of 0.5% of glacial acetic acid in water (adjust with ammonium hydroxide to a pH of 6.2) and acetonitrile. The flow rate was 1.0 mL·min-1, and the UV detection wavelength was 265 nm. Q-TOF technique was used to identify the structures of the main impurities in positive/negative ion modes with ESI as the ion resource.
Piroxicam peak was well separated from each impurity peak. A total of 4 major impurities (≥0.1%) were detected in 17 batches of domestic piroxicam gel: i.e., 2-hydroxy-benzoic acid 2-[bis(2-hydroxyethyl)amino] ethyl ester, 2-hydroxypropyl-4-hydroxybenzoate, 1-hydroxypropyl-2-yl-4-hydroxybenzoate, and 2-methyl-4-methoxy-N-(2-pyridyl)-2H-1,2-benzothiazin-3-formamide-1,1-dioxide, which were for the first time reported in piroxicam gel.
The established HPLC method can be used for impurity detection of piroxicam gel. Impurities in domestic piroxicam gel mainly come from raw materials and excipient ethyl hydroxybenzoate. The production process should be optimized to improve the quality.
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