T/KYXZ 02-2024 Powder-based health care product production technical specifications

Scope

Scope: This standard specifies the technical requirements and definitions, technical requirements, test methods, inspection rules, important notes, packaging and labeling, transportation and storage, and basic requirements for the production of powdered health products. This standard applies to the production of powdered health products; Main technical content: 4.1 Raw materials and auxiliary materials shall comply with the relevant provisions of Parts I, II, and IV of the Pharmacopoeia of the People's Republic of China 2020 Edition. For raw materials and auxiliary materials not covered by the 2020 edition of the Pharmacopoeia of the People's Republic of China, they shall comply with the provisions of current national standards, industry standards, and local standards. For those raw materials and auxiliary materials without corresponding standards, official published literature or detailed descriptions must be provided. It is strictly prohibited to use protected animals and plants as raw materials and auxiliary materials. 4.2 Identification: At least one main raw material of commonly used powdered health products shall be subjected to microscopic identification. 4.3 Sensory evaluation: Sensory evaluation shall comply with the provisions of Table 1. Table 1 Item Indicator Morphology Powdery or fuzzy Color According to the product description Smell According to the product description Impurities No obvious visible foreign impurities Fineness (mesh size) The required mesh size 4.4 Microbiological indicators: Microbiological indicators shall comply with the provisions of Table 2. Table 2 Item Requirement Colony count (CFU/g or CFU/mL) ≤1000 Heat-resistant E. coli/g (or mL) Not detected Staphylococcus aureus/g (or mL) Not detected Pseudomonas aeruginosa/g (or mL) Not detected Mold and yeast total count (CFU/g or CFU/mL) ≤100 4.5 Physicochemical indicators: Physicochemical indicators shall comply with the provi

Development Information

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