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In the development of pharmaceutical formulations, different synthesis processes for raw materials of various origins can result in variations in solubility, crystal form, particle size, and impurities, which may thus affect the consistency of the product. In the consistency evaluation of generic drugs, the particle size control of active pharmaceutical ingredients cannot be overlooked. In the production of active pharmaceutical ingredients, particle size is an essential parameter. Depending on the requirements for tablet dissolution, the particle size of the active pharmaceutical ingredient should be controlled within specific ranges in order to maximize its efficacy. The particle size distribution of the active pharmaceutical ingredient can have a significant impact on the properties of the final product, such as solubility, bioavailability, content uniformity, and stability. Furthermore, the particle size distribution of the active pharmaceutical ingredients and excipients also affects the drug’s flowability, overall homogeneity, compressibility, and other aspects related to manufacturability; these factors can in turn impact the drug’s safety, efficacy, and quality. For drugs classified as BCS Class II, which have high permeability and low solubility, solubility has a significant impact on absorption in the body; therefore, it is necessary to examine the effect of particle size on product quality. If there are differences in particle size across different batches, it has a direct impact on both the efficacy and safety of the drug; therefore, this aspect needs to be closely monitored during the assessment of drug consistency. To improve the in vitro dissolution rate of nifedipine tablets, some researchers examined the effects of drug particle size, diluents, and disintegrants on in vitro dissolution, and compared the dissolution profile curves to select an optimal formulation. The study results showed that the nifedipine tablets prepared using the optimized formula exhibited good dissolution, meeting the requirements specified in the 2000 edition of the Chinese Pharmacopoeia. It was concluded that the formulation of this tablet is reasonable, the preparation process is simple and feasible, and it is suitable for industrial production. Carrying out consistency evaluations for generic drugs enables them to achieve the same quality and efficacy as the original branded drugs. This not only helps to reduce medical costs but also improves the quality of generic drugs, ensuring the safety and effectiveness of medications for the public. Medix Biopharmaceuticals possesses extensive experience in the assessment of the quality consistency of generic drugs. Its comprehensive service platform for such assessments offers thorough comparisons between reference formulations and generic drugs, services for the further development of formulation processes, as well as animal BE testing services. Azithromycin belongs to Category 2 or 4 drugs according to the BCS classification; it has poor solubility, and the particle size of the active pharmaceutical ingredient has a significant impact on its properties both in vitro and in vivo. Establishing a method for determining the particle size and particle size distribution of azithromycin bulk drug helps to achieve effective control over its particle size, accelerates the process of consistency evaluation, and reduces the risks associated with such evaluations. Some researchers have conducted studies on optimizing crystallization processes to improve the particle size of azithromycin drug substance. Studies have found that the particle size of the active ingredient in azithromycin directly affects the production efficiency and product quality of azithromycin formulations (capsules, tablets, etc.). In the experiments, the researchers investigated the effects of crystallization temperature, drying temperature, and crystal growth time on the particle size of azithromycin bulk drug. The experimental results show that the optimal process conditions are: a crystallization temperature of 40°C, a crystal growth time of 120 minutes, and a drying temperature of 60°C. By optimizing the crystallization process, such as by changing the crystallization temperature, the drying temperature, or extending the crystal growth time, it is possible to improve the particle size of azithromycin bulk drug, as well as enhance the production efficiency and product quality of azithromycin formulations. The particle size of the active pharmaceutical ingredient can be controlled by adjusting the parameters used for crushing the drug; thereafter, the particle size is measured using a dry particle size analyzer or a wet laser particle size analyzer, thereby allowing control over the particle size range. The particle size of the API for II, II, and IV has a significant impact on the consistency assessment. Currently, in foreign countries, the range of particle sizes of raw materials can be precisely controlled when manufacturing drugs, while in many domestic pharmaceutical manufacturers, the particle size of APIs is controlled through mechanical grinding; synthetic crystallization processes are used rarely for this purpose, whereas synthetic processes are more commonly employed abroad. Study on the in vitro dissolution characteristics of nifedipine tablets. Study on optimizing the crystallization process to improve the particle size of azithromycin drug substance.