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HPLC is a commonly used method for detecting the chemical purity of substances. For calcium ketoglutarate, this method can accurately determine the content of calcium ketoglutarate. High - quality calcium ketoglutarate products usually have a high purity, generally requiring a purity of over 98%. For example, when used as a raw material for drugs in the pharmaceutical field, high - purity calcium ketoglutarate can reduce the potential risks brought by impurities and ensure the safety and effectiveness of drugs.
During operation, dissolve the sample in an appropriate solvent and inject it into the high - performance liquid chromatograph. The instrument will separate calcium ketoglutarate from other impurities based on the differences in the distribution coefficients of different components between the stationary phase and the mobile phase, and quantitatively analyze its purity through the detected signal peak area or peak height.
Detecting the heavy metal content is a crucial part. Heavy metals such as lead, mercury, cadmium, and arsenic are harmful to the human body and the environment. For high - quality calcium ketoglutarate products, the heavy metal content must be strictly controlled at a very low level. Usually, the lead content is required to be less than 1 ppm (mg/kg), the mercury content is less than 0.1 ppm, etc. These heavy metals may come from raw materials, production equipment, or the production environment.
It is also necessary to pay attention to organic impurities. For example, unreacted raw materials and by - products remaining during the production process are organic impurities. These impurities may affect the performance and application effect of calcium ketoglutarate. Techniques such as gas chromatography - mass spectrometry (GC - MS) can be used to detect the types and contents of organic impurities.
High - quality calcium ketoglutarate is generally a white crystalline powder. If there is a yellowish, grayish color or obvious spots of different colors, it may indicate that the product has been contaminated or deteriorated during the production process. For example, if the product is exposed to strong oxidants or high temperatures during storage, its color may change.
The appropriate particle size distribution is very important for the application of calcium ketoglutarate. In the fields of pharmacy or food additives, products with uniform particle size are more conducive to mixing, dissolution, and absorption. The particle size distribution can be detected by a laser particle size analyzer. Generally, for calcium ketoglutarate used as an oral supplement, a moderate particle size (for example, the average particle diameter is between 10 - 100 μm) is helpful for uniform dispersion and effective absorption in the gastrointestinal tract.
The solubility of calcium ketoglutarate in water is an important quality indicator. Under specified temperature and solvent conditions, high - quality calcium ketoglutarate should have good solubility. For example, at room temperature, it should be able to form a clear and transparent solution in water, which is very crucial for its application in food, beverages, or pharmaceutical preparations. If the solubility is poor, it may affect the uniformity of the product in the formulation, thereby affecting the quality and effect of the product.
Methods such as thermogravimetric analysis (TGA) can be used to detect the thermal stability of calcium ketoglutarate. Observe the change in the sample's weight with temperature at a certain heating rate. High - quality calcium ketoglutarate should have good thermal stability within the normal storage and use temperature range (for example, - 20℃ - 40℃), and no obvious decomposition or deterioration should occur. If a large amount of weight loss occurs at a relatively low temperature, it may indicate that the product contains a large amount of volatile impurities or the product itself has poor stability.
Investigate the stability of calcium ketoglutarate in different chemical environments. For example, observe whether it will undergo chemical reactions in acidic, alkaline solutions or solutions containing other chemicals (such as common food additives or pharmaceutical excipients). High - quality products should be able to maintain their chemical structure and properties unchanged under certain chemical environmental changes to ensure their effectiveness in complex application scenarios (such as compound pharmaceutical preparations or compound food additives).
For calcium ketoglutarate used in fields such as food and medicine, the microbiological limit is an essential indicator to be detected. The total number of bacteria, molds, and yeasts in the product needs to be controlled within a certain range. For example, according to the microbiological limit standards for drugs, the total number of bacteria generally should not exceed 1000 CFU/g, and the total number of molds and yeasts should not exceed 100 CFU/g. If these microorganisms exceed the standard, the product may deteriorate during storage and even pose a threat to the health of users.
Detect whether the product contains pathogenic microorganisms such as Salmonella, Escherichia coli, and Staphylococcus aureus. Once these pathogens are present in the product, they will bring serious health risks. High - quality calcium ketoglutarate products should undergo strict sterilization treatment to ensure the absence of any pathogens.
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