The quality standard of medical plastic bottles for oral preparations should meet both the general requirements of Part IV of China Pharmacopoeia (2025 edition) and the differentiated requirements for different dosage forms. Its core standard is "9624 Guiding Principles of Plastic Materials and Containers for Drug Packaging". The following is a comparison of the differences in core quality standards between oral solid and oral liquid medical plastic bottles:

Oral solid medical plastic bottles:

Core standards: it is necessary to follow the "9624 Guiding Principles" and personalized requirements. Core standard basis: guiding principles of Pharmacopoeia Core quality control differences: Key items of dissolution test: focus on oxidizable substances and nonvolatile substances. Sealing and moisture-proof requirements: If sealing gasket is brought, the fluorescence, opening performance and water vapor permeability of cardboard should be controlled. When carrying desiccant, it is necessary to control the moisture content of desiccant and paperboard. Material specific requirements: polyester materials (such as PET) need to control acetaldehyde. Physical performance: Pay attention to the anti-drop performance (especially with moisture-proof components). Example testing: heat sealing strength, sealing performance of bottle cap.

Oral liquid medical plastic bottles:

Core standards: it is necessary to follow the "9624 Guiding Principles" and personalized requirements. Core standard basis: guiding principles of Pharmacopoeia Core quality control differences: Key items of dissolution test: besides easy oxides and non-volatiles, attention should also be paid to clarity, pH change value and absorbance. Sealing and moisture-proof requirements: not applicable. Material specific requirements: acetaldehyde, ethylene glycol and total terephthaloyl should be controlled for polyester materials; Coloring bottles need to be decolorized. Physical properties: microbial limits need to be controlled; Polyester bottles need to be tested for drop resistance; If the preparation containing ethanol is contained, it is necessary to investigate the ethanol permeability. Example detection: microbial limit, acetaldehyde content. 

General quality requirements for two kinds of oral preparation bottles：

Both solid and liquid oral preparation bottles must meet the following general requirements: Barrier performance: measure the water vapor permeability and oxygen permeability to prevent the drug from being wetted or oxidized. Chemical safety (dissolution test): this is a key project, and the safety is evaluated by detecting substances (such as total nonvolatile matter and easy oxides) that migrate into drugs. The specific test items of oral solid and liquid are different. Material identification: Make sure to use specified materials (such as PE, PP, PET), and identify them by infrared spectroscopy. Elemental impurities: control the content of heavy metals such as lead and cadmium.

How to select and verify compliance: 

1. Standard query and confirmation The most authoritative way is to directly consult the 2025 edition of People's Republic of China (PRC) Pharmacopoeia Part IV. Ask the packaging material supplier for the "Registration Certificate of Pharmaceutical Packaging Materials and Containers" or National Medical Products Administration Drug Evaluation Center (CFDEN) official website for related review registration information, as well as all quality inspection reports that meet the requirements of China Pharmacopoeia. 2. Pay attention to the particularity of materials If it is a polyester bottle (commonly used PET), special attention should be paid to the control of certain impurities such as acetaldehyde and ethylene glycol. If the oral liquid containing ethanol (such as some mixtures) is packaged, the supplier must be required to provide the data of ethanol penetration. 3. Pay attention to the integrity of the packaging system The standard is not only aimed at the bottle itself, but also includes the whole packaging system composed of components such as bottle cap, gasket and desiccant. For example, for a solid medicine bottle with a moisture-proof cover, its sealability, moisture content of desiccant, etc. are the key points of investigation.