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The USP standard of HDPE bottle

Carrie Mar 28,2019 Share this post:

The USP quality standard of HDPE bottle is slightly different from the detection standard of China's 2015 edition of the Pharmacopoeia. The infrared spectroscopy method is slightly different for the bottle body requirements such as differential scanning heat. The following items are as follows:


HDPE bottle

Infrared Spectroscopy

Take the appropriate amount of this product, according to USP34-NF29 Appendix 661, should be consistent with the USP standard high-density polyethylene reference material map.

Differential Scanning Calorimetry

It was determined by the thermal analysis method (USP34-NF29 Appendix 891) and USP34-NF29 Appendix 661. The initial temperature was 40 ° C, the temperature was raised to 200 ° C at a rate of 2 to 10 ° C per minute, and then the temperature was lowered to 40 ° C at a rate of 2 to 10 ° C per minute, and the heat distribution map (nitrogen) was recorded. The USP standard high density polyethylene reference substance was taken and determined by the same method. In the heat distribution diagram of the test article, the endothermic line (melting) should not exceed 6.0 °C compared with the heat absorption line (melting) of the USP standard high-density polyethylene reference product.

Heavy Metals and Nonvolatile Residue (Heavy Metals and Nonvolatile Residue)

Dissolution test device: water bath, 500ml stoppered conical flask, stainless steel scissors, stainless steel blade.

Test equipment and apparatus and treatment: Thoroughly clean all glassware with chromic acid wash (hot nitric acid if necessary), then rinse repeatedly with water for a long time. For the shearing instruments used for subdividing samples, clean them by appropriate methods (such as continuous cleaning with acetone and dichloromethane), thoroughly clean other equipment and devices with appropriate cleaning agents, and use water. Rinse repeatedly for a long time, spare. Preparation of the eluate test solution: Take the inner surface area of the product 600cm2 (divided into about 5cm, a small piece of about 0.3cm wide) three times into three 500ml conical flasks, add about 150ml of purified water, shake and wash small For about 30 seconds, discard the water and repeat the operation twice. After drying at 30-40 ° C, add purified water (70 ° C ± 2 ° C), ethanol (70 ° C ± 2 ° C), n-hexane (50 ° C ± 2 ° C) 200 ml, with a plug, soaked in a water bath for 24 hours . Remove, let cool (but not less than 20 ° C), remove 20 ml of water leaching solution in a 50 ml Nessler colorimetric tube for heavy metal inspection; immediately pour the remaining 3 remaining leachate into a clean 250 ml cone bottle, It has a plug and is used for inspection of non-volatile residues. Purify water, ethanol and n-hexane in the same batch as a blank solution and set aside.

Heavy metal: Precisely measure 20ml of water immersion liquid into 50ml Nessler colorimetric tube (filtered if necessary), adjust pH to 3.0~4.0 with 1mol/L acetic acid or 6mol/L ammonium hydroxide (ie ammonia water) For precision pH test paper), dilute to 35 ml with purified water and mix to serve as a tube. Take another 50ml Nessler colorimetric tube, add 2.0ml standard lead solution, add 20ml of purified water, adjust the pH to 3.0~4.0 with 1mol/L acetic acid or 6mol/L ammonium hydroxide (ie ammonia) (with precision The pH test paper was measured, diluted to 35 ml with purified water, and mixed to obtain a tube. Take another 50ml Nessler colorimetric tube, accurately measure 20ml of water immersion liquid into 50ml Nessler colorimetric tube (filtered if necessary), add 2.0ml standard lead solution, use 1mol/L acetic acid solution or 6mol/ The ammonium hydroxide solution of L (ie, ammonia water) was adjusted to a pH of 3.0 to 4.0 (measured with a precision pH test paper), diluted to 35 ml with purified water, and mixed to obtain a tube of B. 1.2 ml of a thioacetamide-glycerol mixed solution and 2 ml of an acetate buffer (pH 3.5) were added to a three-propyl acetate tube, and the mixture was diluted with purified water to 50 ml, and mixed. According to the first method of heavy metal inspection (USP34-NF29 Appendix 231), the color of the test solution (tube) is compared with the color of the control solution (tube) from the top of the three tubes from a white background. It should not be deeper; and the color of the control solution (B-tube) should not be deeper than the color of the monitoring tube (B-tube) (ie, the water-immersed liquid should not contain more than one-millionth of heavy metals).

Non-volatile residue: Take 50ml of purified water, ethanol, n-hexane leaching solution and blank solution, respectively, in a constant weight bismuth (such as better with acid-washed quartz strontium), and evaporate in a boiling water bath. Dry at 105 ° C for 1 hour, take out, let cool, accurately weighed. If it is predicted that the non-volatile residue contains oil, it is necessary to continuously check the enthalpy during heating and evaporation. If it is found that the oil residue spreads along the inner wall of the crucible to the enthalpy, the evaporation rate can be appropriately lowered. The difference between the water non-volatile residue and its blank solution shall not exceed 12.0 mg; the difference between the ethanol non-volatile residue and its blank liquid residue shall not exceed 75.0 mg; the difference between the n-hexane non-volatile residue and its blank residue shall not exceed 100.0 mg.


hdpe bottle with child proof cap

HDPE bottle USP quality standard is mainly for the United States and other regions to meet the USP Pharmacopoeia quality standards and testing methods for HDPE bottles, for the quality standards to make adjustments in the production process and production process, quality control and other aspects, Achieve final compliance with USP standards.

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