Capillary electromigration techniques have become important tools for the analysis of
pharmaceutical drugs. The present review updates on recent developments of the analysis …

The last decade has seen continued development and refinement of guidance related to
mutagenic impurities (MIs); culminating in June 2014 with the publication of ICH M7. This …

As an important chemical raw material, hydrazine brings convenience to people's lives and
provides opportunities for human development. However, the misuse or leakage of …

对药品杂质谱的控制是保证药品安全有效的重要措施, 也是提升国产药品质量的关键环节.
自2010 年提出实施杂质谱控制的基本策略以来, 经近十年持续的努力, 国内已经形成了一个比较 …

Major issues in the pharmaceutical industry involve efficient risk management and control
strategies of potential genotoxic impurities (PGIs). As a result, the development of an …

Over-the-counter medications (OTCMs) are frequently recommended as a first-line treatment
for common ailments, diseases, and illnesses. Oral liquid dosage forms are advantageous …

Nitrobenzaldehyde is the synthetic raw material and an important photodegradation product
of chloramphenicol. With a structural “alert” of human genotoxic potential and reported …

Genotoxic impurities (GTIs) occurred in drugs, and food and environment pose a threat to
human health. Accurate and sensitive evaluation of GTIs is of significance. Ames assay is …

Camphorsulfonic acid salts are commonly used in the manufacturing production of active
pharmaceutical ingredients (APIs) and have the potential to form alkyl camphorsulfonates …

Most of the drugs developed in the recent years originally remain as a weak base or acid,
but drugs in these forms usually have undesirable pharmaceutical characteristics …