Pharmaceutical Industry Standard of the People's Republic of China—Medical Absorbent Cotton （YY/T0330-2015）
In China, as a kind of medical supplies， medical absorbent cotton strictly regulated by the state, the manufacturer of medical absorbent cotton must pass China's national drug administration testing whether have production condition and equipment, the products need to do clinical trials and after expert review by countries medical absorbent cotton product registration certificate, In order to be allowed to go on sale.
In Chinese market,medical absorbent cotton need to comply with Pharmaceutical Industry Standard of the People's Republic of China—Medical Absorbent Cotton （YY/T0330-2015）,which main standard as follows,hope to help you understand medical cotton products.
1/ According to visual observation, medical absorbent cotton should be white or quasi-white in appearance, composed of fibers with an average length of no less than 10 mm, without leaves, peel, seed coat residue or other impurities. There is a certain resistance when stretching, and no dust should fall off when gently shaking.
2/ According to visual observation, medical absorbent cotton should be white or quasi-white in appearance, composed of fibers with an average length of no less than 10 mm, without leaves, peel, seed coat residue or other impurities. There is a certain resistance when stretching, and no dust should fall off when gently shaking.
Reagent -Zinc chloride iodide solution: use 10 5mL plus or minus 0.1 ml water, dissolve 20 g± 0.5 g zinc chloride, and 6 5g ±0.5 g potassium iodide, add 0.5 g ±0.5 g thrust out after shaking 15 min, filter when necessary, avoid light preservation. Zinc chloride-formic acid solution: dissolve 20 g chloride-0.5 g pound-in a solution of 8 50 g/L anhydrous formic acid with 80 g plus or minus 1g.
Identification A: when viewed under A microscope, each visible fiber should consist of A single cell up to 4cm in length and 40μm in width, with A thick, round-walled flat tube, usually twisted.
Identification B: When exposed to retiring chlorination bowl solution, the fiber should be purple.
Identification C: Add 10 mL chlorinated pot-formic acid solution to 0.1g sample, heat it to 4 00C, place it for 2.5 h and shake it continuously, it should not dissolve.
3/ Foreign fibres: When examined under a microscope, they should contain only typical cotton fibres, allowing occasional small isolated foreign fibres.
4/ Cotton knot: about 1g medical absorbent cotton was evenly spread in 2 colorless and transparent flat plates, each plate with an area of 10 cmX10cm, the number of neps in the sample should not exceed that of the standard nep (RM) when examined by transmitted light.
5/ Soluble in water: take 5. 0g absorbent cotton, put it into 500 mL water and boil it for 30 min, stir it from time to time and supplement evaporation
The amount of water lost. Carefully pour out the liquid. Squeeze the remaining liquid from the sample with a glass stick and mix it with the poured liquid while it is hot filtering. 400 mL of filtrate was evaporated (corresponding to 4/5 of sample mass) and dried at 100 ℃ ~ 105 ℃ to constant weight. Calculate the percentage of residue to the actual sample mass. The total amount of soluble matter in water should not be greater than 0.50%.
6/ Ph: Reagent - phenolphthalein solution: dissolve 0.1 g ± 0.01g phenolphthalein in 80 mL ethanol solution (volume fraction 96%) and dilute to 100 mL with water. Methyl orange solution: 0.1g ± 0.1g methyl orange was dissolved in 80 mL water and diluted to 100 mL with 96% ethanol solution.
Test: 0.1 ml phenolphthalein solution was added into 25 ml test solution S, 0.05 was added into the other 25 ml test solution SML methyl orange solution, see if the solution appears pink. The solution should not appear pink.
7/ Sinking time: sinking time should not exceed 10 s.
8/ Water absorption: the water absorption of each gram of medical absorbent cotton should not be less than 23.0g.
9/ Soluble matter in ether: the total amount of soluble matter in ether should not be greater than 0.50%.
10/ Fluorescence: medical absorbent cotton should only be microscopic brown and purple fluorescence and a small amount of yellow particles. Except for a few isolated fibers, no should show strong blue fluorescence.
11/ Drying weight loss: the weight loss should not be greater than 8.0%.
12/ Sulfate ash: Sulfate ash should not be greater than 0. 40%.
13/ Surface active substance: the foam of surface active substance should not cover the entire liquid surface.
14/ Leacheable colouring substance: The colour of the obtained extract shall not be darker than the reference solution Y5 and GY6 specified in Appendix A or a control solution prepared by adding 7. 0mL hydrochloric acid solution (concentrated mass) to 3. 0mL primary blue solution
And dilute 0.5 mL of the above solution to 100 mL with hydrochloric acid solution (mass concentration of 10 g/L).
15/ Ethylene oxide residue: if medical cotton products are sterilized with ethylene oxide, the residue of ethylene oxide should not be more than 10 mg/kg.
16/ Bioload: for non-sterile supply of medical absorbent cotton, the manufacturer shall label the maximum bioload per gram of the product some of the number of microbes.
Post time: Mar-12-2022