HDPE bottle latest YBB national standard will meet ICH standard

The latest YBB national standard for HDPE bottles has entered the review stage, and the new national standards that China has officially joined the International Human Drug Registration Technical Coordination (ICH) will meet international standards.

Organisation of ICH

HDPE bottle(pharmaceutical packaging) CDE quality standards can be tested and quality control according to YBB quality standard items. Specific quality standard test items: appearance, sealing, drop test, water vapor transmission, ignition residue, dissolution test, n-hexane, non-volatiles , microbial limit, decolorization test, abnormal toxicity.

[Appearance] should have a uniform color and no obvious color difference. The surface of the bottle should be smooth and flat, with no deformation or obvious scratches. There must be no blisters, oil, or air bubbles. The mouth of the bottle should be smooth and smooth.

[Identification] (1) Infrared spectrum Take the appropriate amount of this product and measure it according to the fourth method of infrared spectrometry (YBB00262004-2015). It should be consistent with the control map.

(2) Density Take 2g of this product, add 100mL of water, reflux for 2 hours, let cool, and dry at 80 °C for 2 hours, the density of this product should be 0.935~0.965g/cm3 as determined by density measurement method (YBB00132003-2015).

[Sealing] (1) Take the appropriate amount of this product, use a force wrench (torque shown in Table 1) to tighten the bottle and cap. The bottle mouth and cap should be properly matched, and the tooth should not be slipped.

(2) Take appropriate amount of this product, put appropriate amount of glass beads in the bottle, screw the bottle cap (the test bottle with screw cap, tighten the bottle and cap with the force wrench, torque shown in Table 1), put it in the belt The container of the air suction device is immersed in water, and vacuumed to a vacuum of 27 KPa for 2 minutes, and no water or bubbling may occur in the bottle.

[Resistance] Take an appropriate amount of this product, add the aqueous solution to the indicated capacity, and naturally fall from the specified height to a horizontal rigid smooth surface, and should not be broken.

[Water vapor transmission amount] Take the appropriate amount of this product, according to the third method of water vapor transmission measurement method (YBB00092003-2015), at a temperature of 20 ± 2 ° C, relative humidity of 65 ± 5%, placed for 14 days, weight loss Do not exceed 0.2%.

[Residue residue] The residual residue must not exceed 0.1% (the residual residue of the bottle containing sunscreen should not exceed 3.0%).

[Extraction test] Preparation of test solution: Take three parts of the flat surface of the product with a surface area of 600cm2 (divided into 5cm and 0.3cm wide), place them in a conical flask, add water, shake and wash the small pieces. Discard the water and repeat the operation once. After drying at 30 ° C ~ 40 ° C, soaked with water (70 ± 2 ° C), 65% ethanol (70 ± 2 ° C), n-hexane (58 ± 2 ° C) 200mL for 24 hours, then taken out and allowed to cool to room temperature, with the same The batch test was supplemented with the solvent to the original volume as the leachate, and the same test was carried out with the same batch of water, 65% ethanol and n-hexane as the blank solution:

Clarity The water is supplied to the test solution and checked according to the law (Chinese Pharmacopoeia 2015 Edition General Regulation 0902). The solution should be clarified; if it is turbid, it should not be thicker than the No. 2 turbidity standard solution.

pH change value Take 20 mL of water test solution and water blank solution, respectively, add 1 mL of potassium chloride solution (1→1000), and determine according to law (Chinese Pharmacopoeia 2015 edition general rule 0631), the difference between the pH values of the two should not exceed 1.0.

Absorbance Take the appropriate amount of water for the test solution. According to the UV-visible spectrophotometry (Chinese Pharmacopoeia 2015 edition general rule 0401), the maximum absorption in the wavelength range of 220-360 nm shall not exceed 0.10.

Easy to measure the amount of water to test the solution 20mL, precision addition of potassium permanganate titration solution (0.002mol / L) 20mL and dilute sulfuric acid 1mL, boil for 3 minutes, rapid cooling, add 0.1g potassium iodide, placed in the dark for 5 minutes, Titrate with sodium thiosulfate titration solution (0.01mol/L), titrate to near the end point, add 5 drops of starch indicator solution, continue titration until colorless, and take water blank solution in the same way, both consume sodium thiosulfate titration solution The difference must not exceed 1.5mL.

Non-volatiles The difference between the n-hexane non-volatile residue and its blank residue should not exceed 75.0 mg.

Heavy metals Containing heavy metals must not exceed one in a million.

[Decolorization test] (Colored bottle) Take the number of this product, cut off the surface area of 50cm2 (in terms of the inner surface), cut into 2 × 0.3cm pieces, and divide into three cone-shaped flasks, respectively, add 4% acetic acid solution (60 ±2 ° C), 65% ethanol solution (25 ± 2 ° C), n-ethane (25 ± 2 ° C) 50mL soak for 2 hours, with the same batch of 4% acetic acid solution, 65% ethanol solution, n-ethane as a blank solution, The color of the soaking solution should not be darker than the blank.

HDPE bottle with child proof cap

[Microbial limit] The number of bacteria should not exceed 100 cfu per bottle. The number of mold and yeast should not exceed 100 cfu per bottle. Escherichia coli should not be detected in each bottle.

[Abnormal toxicity] The number of this product is only cleaned with water, take 500cm2 (in terms of internal surface area), cut into pieces, add 50mL of sodium chloride injection, set high pressure steam sterilizer at 110 ° C for 30 minutes, then take out, cool After the standby, the same batch of sterile sodium chloride injection as a blank, intravenous injection, according to the law (Chinese Pharmacopoeia 2015 version of General Rules 1141), should meet the requirements.