[Appearance] take this product the right amount, in the natural light bright, facing visual inspection. Should have a uniform color, not a significant color. The surface of the bottle should be smooth, smooth, no deformation and obvious scratches. Do not have trachoma, oil, bubbles. Bottles should be smooth and smooth.
[Identification] (1) infrared spectrum to take this product amount, deposited on the micro-hot potassium bromide wafer, according to spectrophotometry (the People's Republic of China Pharmacopoeia 2000 edition two Appendix ⅣC) determination, should be consistent with the control map.
(2) density of this product 2g, add water 100ml, Vinyl Bags reflux 2 hours, let cool, 80 ℃ drying 2 hours, precision
Weighing (Wa). And then set the appropriate solvent (density d), accurately weighed (Ws).
HDPE density should be 0.935 ~ 0.965 (g / cm3).
【Seal】 Take this product in the amount of each bottle into the appropriate amount of glass ball, screw cap (with a screw cap test bottle, Vinyl Bags with a force wrench to tighten the bottle and cover, torque see Table 1), set In the container with the suction device, immersed in water, vacuum to a vacuum of 27kPa, Vinyl Bags for 2 minutes, the bottle shall not have water or bubbling phenomenon.
Oscillation test] Take this product the right amount, in each bottle into the acidic water as a marker, screw cap (with a screw cap test bottle with a measuring wrench to tighten the bottle and cover, torque see Table 1) with bromine Phenol blue test paper (immersed in the filter paper diluted 5 times the bromophenol blue test solution, soaked and dried) tightly squeeze the neck of the bottle, Vinyl Bags set the oscillator (oscillation frequency of 200 ± 10 times per minute) after 30 minutes, Blue test paper may not change color.
[Water vapor permeation] Take this product the right amount, Vinyl Bags wipe each test bottle with silk cloth, the bottle cap open, off 30 times, in the test bottle by adding desiccant anhydrous calcium chloride (remove the 4 mesh sieve Dry powder, set at 110 ℃ for 1 hour): 20ml or 20ml or more of the test bottle, Vinyl Bags add desiccant to the bottle from the mouth 13mm; less than 20ml of the test bottle, add the dry dose of 2/3 volume, tight. Another two test bottles into the same amount of glass beads with the desiccant, Vinyl Bags for the control. After the test bottle was tightened, the weight was set, and then the test flask was placed in an environment with a relative humidity of 95 ± 5% and a temperature of 25 ° C ± 2 ° C for 72 hours, taken out and left at room temperature for 45 minutes. Calculate the amount of water vapor infiltration by the following formula, not over 100mg / 24h · L.
(Mg); the average weight (mg) of the Ci- control bottle before the test; the Tt-test bottle Weight (mg); Ct-control bottle after the average weight (mg);
【Residue on ignition】 Take this product 2.0g, Vinyl Bags according to the law (the People's Republic of China Pharmacopoeia 2000 edition two Appendix Ⅷ N), shall not exceed 0.1% (including opacifier bottle burning residue shall not be over 3.0%).
[Dissolution test] Preparation of the test solution were taken as the product of the inner surface area of 600cm2 (divided into 5cm, width 0.3cm small pieces) three sets of stoppered conical flask, add water, shake the small pieces, , Repeated operation twice. After drying at 30 to 40 ° C, the mixture was immersed in 200 ml of water (70 ° C ± 2 ° C), 65% ethanol (70 ° C ± 2 ° C) and n-hexane (58 ° C ± 2 ° C) for 24 hours,Vinyl Bags With the same batch of test solvent to the original volume as a leaching solution, with the same batch of water, 65% ethanol, n-hexane as blank liquid.
(0.002mol / L) 20ml and dilute sulfuric acid 1ml, boiled for 3 minutes, quickly cooled, adding 0.1g potassium iodide, placed in the dark for 5 minutes, with the amount of potassium iodide titration solution (0.002mol / L) Sodium thiosulfate titration solution (0.01mol / L) titration, Vinyl Bags titration to the end of the point, add starch indicator solution 0.25ml, continue to titration to colorless, and the other water blank liquid with the law, the difference between the two consumption of titration ml.
Heavy metal precise amount of water extract 20ml, Vinyl Bags plus acetate buffer (pH3.5) 2ml, according to the law (the People's Republic of China Pharmacopoeia 2000 edition two Appendix Ⅷ H), containing heavy metals shall not be one millionth.
50% ethanol, n-hexane leachate and blank liquid 50ml were placed in the constant weight of the evaporating dish, the water bath evaporated, Vinyl Bags dried at 105 ℃ for 2 hours, after cooling accurately weighed, the water non-volatile residue with its The difference between the residue of the blank liquid residue shall not exceed 12.0mg; 65% ethanol volatile residue and its blank liquid residue difference should not exceed 50.0mg; Vinyl Bags n-hexane non-volatile residue and its blank liquid residue difference should not exceed 75.0mg.