Oral solid medicinal polyester bottle (PET bottle) quality standard

The quality standard for oral solid medicinal polyester bottles in 2019 is applicable to medicinal plastic bottles for oral solid preparations produced by injection blow molding process using polyethylene terephthalate (PET) as the main raw material.

oral solid PET bottle for pharmaceutical packaging

Appearance: In the bright natural light, face up to the visual inspection. It 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 spectroscopy The fourth method of infrared spectrometry (YBB0026004-2015) for packaging materials should be consistent with the control map.

2. Density Densitometric method (YBB00132003-2015) should be 1.31~1.358g/cm3.

Sealing: immersed in water, no water or bubbling in the bottle.

Oscillation test: Oscillating in an oscillator for 30 minutes, the bromophenol blue test paper should not be discolored.

Water vapor transmission: According to the third method of water vapor permeation measurement method (YBB00092003-2015), it should not exceed 100mg/24HL.

Acetaldehyde: Determined by the first method of acetaldehyde assay (YBB00282004-2015). Not more than two tenths of a million.

Residues of ignition: inspection according to law (General Rules of the Chinese Pharmacopoeia 2015 Edition 0841), the residual residue shall not exceed 0.1%.

Dissolution test:

1. Easy oxides The same method of operation, the difference between the two consumption of sodium thiosulfate titration solution (0.01mol / L) should not exceed 1.5ml.

2. Non-volatile matter The difference between the non-volatile residue of n-hexane and the residue of the blank liquid shall not exceed 75mg.

3. Heavy metals According to the law (Chinese Pharmacopoeia 2015 General Rules 0821 first law), heavy metals should not exceed one in a million.

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

Abnormal toxicity: check according to law (Chinese Pharmacopoeia 2015 edition general rule 1141), should comply with the regulations.