Group Standards of the People's Republic of China CN / TUANTI
Latest
T/KYXZ 02-2024
Scope
4. Technical Requirements 4.1 Raw Materials and Auxiliary Materials Raw materials and auxiliary materials shall comply with the relevant provisions of Parts I, II, and IV of the 2020 edition of the *Pharmacopoeia of the People's Republic of China*. Raw materials and auxiliary materials not covered by the 2020 edition of the *Pharmacopoeia of the People's Republic of China* shall comply with the provisions of current national standards, industry standards, local standards, etc. For raw materials and auxiliary materials without corresponding standards, officially published literature or detailed descriptions must be provided. The use of nationally protected animals and plants as raw materials and auxiliary materials is strictly prohibited. 4.2 Identification For commonly used powdered health care products, at least one main raw material shall be selected for microscopic identification. 4.3 Sensory Evaluation Sensory evaluation shall comply with the provisions of Table 1. Table 1 Item Indicator Form Powder or Fleece Color According to product description Color Odor According to product description Odor Impurities No obvious visible foreign impurities Fineness (sieve mesh) Required sieve mesh 4.4 Microbiological Indicators Microbiological indicators shall comply with the provisions of Table 2. Table 2 Project Requirements Total bacterial count (CFU/g or CFU/mL) ≤1000 Thermoresistant coliforms/g (or mL) Not detectable Staphylococcus aureus/g (or mL) Not detectable Pseudomonas aeruginosa/g (or mL) Not detectable Total mold and yeast count (CFU/g or CFU/mL) ≤100 4.5 Physicochemical Indicators Physicochemical indicators shall comply with the provisions of Table 3. Table 3 Project Unit Indicator Heating time (self-heating type) min ≤20 Temperature duration (self-heating type) h ≥0.5 Maximum temperature (self-heating type) ℃ ≤60 Mercury (as Hg) mg/kg ≤1 Arsenic (as As) mg/kg ≤2 Lead (as Pb) mg/kg ≤10 Cadmium (as Cd), (not tested for black plaster) mg/kg ≤5 4.6 Safety Non-toxic, harmless, and non-irritating to the skin. 4.7 Net content and allowable shortage quantity: Product specifications should be set according to market demand. Simultaneously, the allowable shortage quantity must comply with the relevant provisions of the "Regulations on the Supervision and Management of Quantitatively Packaged Commodities". 5. Test Methods 5.1 Sensory Evaluation: Place an appropriate amount of product in a white porcelain dish and observe its shape, color, impurities, and fineness under natural indoor light. Also, smell its odor. 5.2 Physicochemical Indicators 5.2.1 Heating time, temperature duration, and maximum temperature shall be conducted according to the methods specified in the People's Republic of China Pharmaceutical Industry Standard "YY 0060-2018 Hot Compress Patches (Bags)". 5.2.2 Mercury, arsenic, cadmium, and lead shall be tested according to the methods specified in the "Cosmetic Safety Technical Specifications 2015 Edition". 5.3 Microbiological Indicators 5.3.1 Total bacterial count shall be tested according to the methods specified in the "Cosmetic Safety Technical Specifications 2015 Edition". 5.3.2 Heat-resistant coliforms shall be tested according to the methods specified in the "Cosmetic Safety Technical Specifications 2015 Edition". 5.3.3 Staphylococcus aureus shall be tested according to the methods specified in the "Cosmetic Safety Technical Specifications 2015 Edition". 5.3.4 Pseudomonas aeruginosa shall be tested according to the methods specified in the "Cosmetic Safety Technical Specifications 2015 Edition". 5.3.5 Total mold and yeast count shall be tested according to the methods specified in the "Cosmetic Safety Technical Specifications 2015 Edition". 5.3.6 Safety shall be tested according to the methods specified in the "Cosmetic Safety Technical Specifications 2015 Edition". 5.3.7 Net content and permissible shortage shall be tested according to the methods specified in JJF 1070-2023. 4.7 The specifications of the product, including net content and permissible shortage, should be set according to market demand. Simultaneously, the permissible shortage must comply with the relevant provisions of the "Regulations on the Supervision and Management of Quantitatively Packaged Commodities". 5 Test Methods 5.1 Sensory Evaluation: Take an appropriate amount of the product and place it on a white porcelain dish. Observe its shape, color, impurities, and fineness under natural indoor light, and smell its odor.
T/KYXZ 02-2024 history
2024T/KYXZ 02-2024 Technical Code for Production of Powder Healthcare Products