There are no regulations for the time being. But some big companies can do some self-discipline. Then you have to deal with specific materials, specific processing. The following information is provided for your reference: dangerous chemicals refer to explosives, compressed gases and liquefied gases, flammable liquids, flammable solids, spontaneous combustion and flammable substances when wet, oxidants and organic peroxides, toxic substances and corrosive substances listed in the classification standards stipulated by China's national standards. Most drugs in the laboratory are not marked with expiration date, because chemical agents (especially inorganic agents) generally do not deteriorate under scientific preservation methods. However, the service life of the preparation is not permanent, because in the process of preservation, especially when taking the preparation, it will inevitably come into contact with air or other substances, which will lead to slow reaction, and when it accumulates to a certain extent, it will reach the so-called deterioration, so it is impossible to find the expiration date on the trademark, because the manufacturer cannot know your storage conditions. Almost all chemicals need to be tested before use. If the impurities in it exceed the standard and affect the use, it can be defined as deterioration and cannot be used. 1. According to People's Republic of China (PRC) GB 15346-94 chemical reagent packaging standard:

Article 9. 1. 1. M regulation: if the period of validity needs to be indicated, it must be indicated; Production date or batch number.

2. Classification of chemical reagents in China:

Excellent purity (GR, green label): the main components are high in content and purity, which is suitable for accurate analysis and research, and some of them can be used as standard materials.

Analytical purity (AR, red standard): high content of main components, high purity and low interference impurities, suitable for industrial analysis and chemical experiments.

Chemical purity (CP, blue label): high content of main components, high purity and many interfering impurities, suitable for chemical experiments and synthetic preparations.

Experimental purity (LR, yellow label): high content of main components, poor purity, no impurity content, only suitable for general chemical experiments and synthetic preparation.

Indicator and stain (ID or SR, purple label): Requires unique sensitivity.

Designated Grade (ZD): Chemical reagents customized for specific users according to the quality control indicators required by users.

Electronic purity (MOS): It is suitable for producing electronic products, and the content of electronic impurities is extremely low.

Equivalent reagents (3N, 4N, 5N): the content of main components is above 99.9%, 99.99% and 99.999% respectively. 3. The validity period of chemical reagents

During the storage, transportation and sales of chemical reagents, affected by external factors such as temperature, light, air and water, physical and chemical changes such as deliquescence, mycin, discoloration, polymerization, oxidation, volatilization, sublimation and decomposition are easy to occur, making them ineffective and unusable. Therefore, reasonable packaging, appropriate storage conditions and transportation methods must be adopted to ensure that chemical reagents do not deteriorate during storage, transportation and sales. If there are special requirements for storage and transportation, they shall be handled according to the special requirements. Some chemical reagents have a certain shelf life, so be careful when using them.

The validity period of chemical reagents varies greatly with the change of chemical properties. Generally speaking, the longer the shelf life of chemically stable substances, the simpler the storage conditions. To preliminarily judge the stability of a substance, the following principles can be followed:

Inorganic compounds can be used for a long time because they are well preserved and well packaged. However, those substances that are easily oxidized and deliquescent can only be stored in dark, cool and dry conditions for a short time (1 ~ 5 years), depending on whether the packaging and storage conditions meet the requirements.

Organic small molecular weight compounds are generally volatile, airtight in packaging and can be stored for a long time. However, substances that are easily oxidized, decomposed by heat, polymerized and sensitized can only be stored in the dark, dark and dry conditions for a short period of time (1 ~ 5 years), depending on whether the packaging and storage conditions meet the requirements.

Organic polymers, especially biological materials, such as oils, polysaccharides, protein, enzymes, peptides, etc. It is easily influenced by microorganisms, temperature and light, so it loses its activity or spoils. Therefore, they should be stored in cold storage (freezing) for a short time.

In principle, reference materials, reference materials and high-purity materials should be kept in strict accordance with the preservation regulations to ensure that the packaging is intact and avoid being affected by the chemical environment, and the storage time should not be too long. Generally speaking, reference materials must be used within the validity period.

4. Pay special attention to the provisions of the benchmark! Some thoughts on establishing the validity period of chemicals

Author Chen Haifeng

The validity period in this paper refers to the time period when the quality of packaged drugs in the market still meets the registered quality standards after being placed under the specified storage conditions. The validity period of drugs should be combined with the results of accelerated test and long-term test, and appropriate statistical analysis should be made. The final validity period is generally determined by long-term test results [1].

However, in the review, there are still some problems in determining the validity period. For example, based on business needs, manufacturers usually want to set the validity period longer, but they often ignore some factors that may affect the quality and safety of drugs, such as paying less attention to the influence of special climatic environment such as high temperature, high humidity and strong light in the sales area on the stability of drugs. In this paper, some points that should be paid attention to when determining the validity period are summarized as follows for reference.

First, the effectiveness of establishing the stability test foundation should be reliable.

The basis of stability test means that the design of accelerated test and long-term test should be reasonable, the batch and scale of samples should meet the requirements, the investigation items should be comprehensive and sensitive, the analysis methods of each item should be fully verified, and the test data should be accurate. Without the above detection basis, it is impossible to accurately determine the expiration date, and it is also impossible to guarantee the quality and safety of products after they are listed in a certain period of time.

For example, the supplementary application extends the validity period (from 24 months to 36 months), but the sample batch used is still the pilot product applied for registration and listing. In this case, it is not appropriate to extend the validity period to 36 months. General production enterprises should continue to carry out large-scale long-term experiments after being approved for listing. At this time, it is necessary to provide large-scale stability data to support the validity period of 36 months.

Another common situation is that when establishing or extending the validity period of long-term trials, there is a lack of investigation on key indicators such as related substances or degradation products. At this time, it is impossible to comprehensively evaluate the change of drug quality over time, so it is impossible to support the applied validity period.

Second, we should consider the influence of the specific climate in the product sales area.

At present, the general conditions adopted in long-term stability test are formulated according to the international climate zone. Paul Schumacher defined four long-term stability test conditions in 1972 and Wolfgang Grimm in 1986 and 1998 according to four different international climatic zones. Among these four climatic zones, the fourth climatic zone, that is, high temperature and high humidity environment, is the most demanding condition for drug quality assurance. The above practices have been adopted by some national authorities and gradually become the standard practice of stability research. At the fourth meeting of the WHO Expert Committee on Pharmaceutical Formulation Specification held in Geneva on June 5438+ 10, 2005, it was suggested that the climatic zone IV (humid and hot zone) should be divided into two climatic zones, namely IVA and IVB, in which the long-term stability condition of IVA is 30 ℃/ 65% RH and IVB is 30 ℃/ 75% RH. The climatic zone division recommended by the WHO draft and the corresponding long-term stability test conditions are shown in the following table [2].

The existing guidelines in China adopt the second climate zone [1], taking into account the average temperature and humidity in all parts of China. The long-term test conditions of domestic applied materials are usually: 25℃ 2℃, 60% RH 10% RH. But this is only a general requirement, and some special circumstances were not taken into account when drafting the guiding principles.

For example, China has a vast territory, with great east-west longitude and north-south latitude, and the climate varies greatly from place to place. For example, there are significant differences in temperature, humidity and illumination between Hainan and Northeast China (such as Heilongjiang Province) and Northwest China (such as Xinjiang). If subdivided, some parts of China may be located in climate zone III or even IV. The stability of the same drug in these places may be different, and these differences need to be considered when formulating the expiration date. When the same drug is listed in these different regions, it may have different expiration dates. If these differences are ignored, the stability under some harsh climatic conditions, such as high temperature, high humidity and strong light, is not investigated in the long-term experimental design, which is likely to lead to the unqualified product quality during the validity period when the drugs are stored and sold in these special climatic environments.

ICH Q 1F specifies the stability registration data of climatic zones Ⅲ and Ⅳ respectively [5]. It is suggested that 30℃ 2℃ and 65% RH±5% RH should be used as long-term stability test conditions. The reason why WHO subdivides climatic zone IV is that although it belongs to humid and hot zone, different humidity in it will also have different effects on drug stability.

As the quality of drugs is mainly the responsibility of manufacturers, it is suggested that enterprises should conduct long-term tests (25℃ 2℃, 60% RH 10% RH) according to the climatic conditions in the areas where drugs are sold and used. ), increase the humidity and temperature, and use the long-term test conditions in climate zone III or climate zone IV for a certain period of time to obtain the stability data of these special climate zones and ensure the stability of drug sales and use in these areas. If the drug is used in hot and humid areas, it should be supported by long-term stability test data above 30℃/RH65%. If the results show instability, corresponding measures should be taken, such as using more protective packaging (such as double-layer aluminum foil blister packaging for solid preparations) to improve stability.