2019 latest oral solid pharmaceutical low-density polyethylene moisture-proof cap quality standard

The latest oral solid pharmaceutical low-density polyethylene moisture-proof cap quality standard for 2019 is applicable to oral solid pharmaceutical plastic bottle caps produced with low-density polyethylene as the main raw material, and with silica gel desiccant to prevent moisture from cardboard as a barrier material. 

effervescent caps with desiccant

moisture proof caps

[Appearance] Take the appropriate amount of this product, and look at the visual inspection in the bright place of natural light. It should have a uniform color and no obvious color difference. The surface of the cap should be smooth and flat, without deformation and obvious scratches, and must not have sand holes, oil stains or air bubbles. The surface of the dialysis paperboard has no dirt, should be flat, and fit properly with the tank; the color of the desiccant is normal and there is no dirt.

[Infrared spectroscopy] (1) Infrared spectroscopy * Take the appropriate amount of caps and measure according to the fourth method of infrared spectrometry (YBB00262004-2015) of packaging materials, which should be basically consistent with the control map.

(2) The density of the outer cover is 2.0g, determined by the density measurement method (YBB00132003-2015), and should be 0.935-0.965 (g/cm3)

Burning residue] Take the outer cover 2.0g and check according to the law (Chinese Pharmacopoeia 2015 edition general rule 0841). The residual residue must not exceed 0.1%. (The ignition residue containing sunscreen should not exceed 3.0%).

[Water content of desiccant] The moisture content should not exceed 4.8%.

[Drying agent saturated moisture absorption rate] The saturated moisture absorption rate of the silica gel desiccant should not be less than 30%.

[Dry agent short-term moisture absorption rate] The short-term moisture absorption rate of silica gel desiccant should not exceed 3%.

[Anti-drop performance] Take the appropriate amount of cap, drop at a height of 1 m, the cap should not be broken, and the desiccant should not leak out.

[Cardboard moisture content] The moisture content should not exceed 6.0%.

[Physical and chemical indicators of cardboard]

  Arsenic (as As) Fluorescence inspection Take 100cm2 of cardboard and place the contact surface under ultraviolet light with wavelengths of 365nm and 254nm. No flake fluorescence is allowed.

[Decolorization test] Take 5 pieces of paper, add water (60 °C ± 2 °C, 2h), soak in n-hexane (25 °C ± 2 °C, 2h) 50ml, take two different solvents as blank solution, soak The color of the liquid should not be darker than the blank.

[Dissolution test] N-hexane is a blank solution.

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

Non-volatiles The difference between the n-hexane non-volatile residue and its blank residue should not exceed 200.0 mg.

[Microbial limit] The number of bacteria should not exceed 1000 cfu per bottle cap. The number of mold and yeast should not exceed 100 cfu. The cap of Escherichia coli should not be detected.

[Abnormal toxicity] According to the law (Chinese Pharmacopoeia 2015 General Rules 1141), it should meet the requirements.

Oral solid pharmaceutical low-density polyethylene moisture-proof caps are mainly used in pharmaceutical packaging, medical moisture-proof drugs (caps with desiccant bottles), test strip packaging and other drugs that require moisture resistance and high sealing.