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Quality Standard For Oral Solid Preparations Medicinal Plastic Bottles
- Jun 24, 2017 -

Oral solid preparations Pharmaceutical plastic bottles of the technical requirements are mainly physical properties, and chemical properties of the two major categories, 10 components. There are appearance, material identification, sealing, shock experiment, water vapor permeation, acetaldehyde, incineration residue, dissolution test, microbial limit, abnormal toxicity. We will analyze the small method of detection.

Oral solid preparations medicinal plastic bottles of the technical requirements are the following

1, the appearance of quality

Should have a uniform color, no obvious color. The bottle surface should be smooth, smooth, no deformation and obvious scratches. No trachoma, oil, bubbles. Bottles should be smooth and smooth.

2, identification

Mainly through the infrared spectrum and density of the material qualitative determination

3, sealing

To the appropriate amount of the bottle, respectively, in the test bottle into the appropriate amount of glass beads, screw cap (with a screw cap test bottle, with a force wrench to tighten the bottle and cover), into the evacuation device with the container, water Soaked, pumping control to 27kPa, to maintain 2min, the bottle without water or bubbling phenomenon.

4, sealing

Each test bottle was filled with acidic water level marker, screwed to the bottle with bromophenol blue test paper (diluted 5 times the filter paper bromophenol blue test solution, soaked and dried) tight package bottleneck to the oscillator after 30min, bromine Phenol blue test paper does not change color.

5, water vapor penetration

In the test bottle, anhydrous calcium chloride desiccant was added and the water was vaporized at a temperature of 25 degrees and a relative humidity of 95%. According to the quality change before and after the placement, the amount of water vapor permeation was not more than 100mg / (24h.L)

6, acetaldehyde

Its requirements withoral liquid preparations medicinal polyester bottles

7, burning residue

Take this product 2.0g, according to "Chinese Pharmacopoeia" two appendix "igniter residue inspection method" to check, leaving the residue shall not exceed 0.1%, with opacifier bottle burning residue shall not exceed 3%.

8, dissolution test

Preparation of the eluent test solution, and then heavy metals, easy to oxide and non-volatile matter inspection

9, microbial limits

Take the dry test bottle, add 1/3 marked capacity of sodium chloride injection, the lid tighten, shake 1min, the extract for membrane filtration, in accordance with the "Chinese Pharmacopoeia" two appendix "microbial limit check method" Determination. Comedy book can not exceed 1000 per bottle, mold, yeast number of bottles per bottle must not exceed 100, E. coli can not be detected per bottle.

10, abnormal toxicity

Wash the test bottle with water, dry, the test bottle, cut broken, add sodium chloride injection, 110 degrees hot and heat sterilization 30min after removal, cooling standby. In accordance with the "Chinese Pharmacopoeia" two appendix "abnormal toxicity check" to check.


Company name: YuHuan Kang-Jia Enterprise Co.,Ltd 

Add: LuPu Town YuHuan County TaiZhou City ZheJiang China

Contact: Gina Jin

Contact phone: 576-87145536

Mobile phone: 13858057637

Fax: 576-87141044

E-mail:gina.jin@kang-jia.com