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Test paper bottle technical requirements and quality standards
Author:Admin Source: Time:20-04-24 20:52:38 Views:

Test paper bottle refers to the packaging used for holding test paper. The packaging is mainly used for the packaging of test strips and various test paper, and most of the bottles are pasted with the corresponding color test results. As the test paper has high requirements on the moisture-proof and sealability of packaging, the technical requirements can be referred to the quality standard of oral solid medicinal low-density polyethylene moisture-proof combination bottle cap.


Test paper bottle technical requirements and quality standards

48 mm paper bottles


The technical requirements and test methods of the test paper bottle are as follows (for reference only) :

[Appearance] Take an appropriate amount of this product and visually inspect it under bright natural light. Should have uniform and consistent color, no obvious color difference. The surface of the bottle cap should be smooth and smooth, without deformation and obvious scratches, no sand holes, oil stains, bubbles. There is no dirt on the surface of dialysis board, which should be flat and suitable for the tank. Desiccant color normal, no dirt.

(1) Infrared spectrum * Take appropriate amount of bottle cap and measure it according to the fourth method of packaging material infrared spectroscopy (YBB00262004-2015), which should be basically consistent with the control spectrum.

(2) Take outer cover 2.0g for density measurement, and use the photodensity determination method (YBB00132003-2015), which should be 0.935-0.965(g/cm3).

[Burning residue] Take outer cover of 2.0g and check according to law (General rule of Chinese Pharmacopoeia 2015 edition 0841) the residual residue shall not exceed 0.1%. (Not more than 3.0% of the incandescent residue containing sunscreen).

[Moisture content of desiccant] the moisture content shall not exceed 4.8%.

[Desiccant saturation moisture absorption rate] The saturation moisture absorption rate of silica gel desiccant shall not be lower than 30% respectively.

[Short-term moisture absorption rate of desiccant] The short-term moisture absorption rate of silica gel desiccant shall not exceed 3% respectively.

[Anti-dropping performance] Take the appropriate amount of cap and place it at a height of 1 meter. The cap shall not break and the desiccant shall not leak out

[Board moisture content] The moisture content shall not exceed 6.0%.

Physical and chemical indexes of paperboard

Fluorescence examination for arsenic (As) : 100cm2 of paperboard was taken and the drug-contact surface was placed under ultraviolet lamps with wavelength of 365nm and 254nm for examination. No flaky fluorescence was allowed.



[Decoloration test] Take 5 pieces of paper, add water (60 ° C ±2 ° C, 2h), soak 50ml of n-hexane (25 ° C ±2 ° C, 2h), and take two solvents in the same batch as the blank solution. The color of the immersion solution shall not be deeper than the blank solution.



[Dissolution test] N-hexane was the blank solution.



Heavy metals shall not contain more than one part per million of heavy metals.



The difference between nonvolatile n-hexane nonvolatile residue and blank liquid residue must not be more than 200.0 mg.

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

[Abnormal toxicity] When measured according to law (general rule 1141 of 2015 Edition of Chinese Pharmacopoeia), it should meet the requirements.

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