Test requirements for easy oxides of eye drop bottles

Pharmaceutical packaging can protect medicines from environmental influences and maintain the original properties of medicines, facilitating their storage, transportation and use. Eye drop bottles are commonly used packaging for ophthalmic drugs, and their quality directly affects the health and safety of patients. In its quality standards, there are many test items involved, and easy oxide is a very important one.

LDPE eye dropper bottle

Easily oxidized substances refer to substances that are prone to chemical reactions with oxygen in ordinary environments. The common ones are metals that are prone to rust. In the pharmaceutical packaging industry, they generally refer to substances that are prone to oxidation reactions with oxygen, such as organic matter, reducing agents, Sulfur, phosphorus, etc. The control of easy oxides is of great significance to ensure the quality of the drug within the validity period, prevent the chemical reaction between the precipitated reducing substances and the drug, and affect the efficacy and safety of the drug.

For the detection of easy oxides, there are specific requirements in YBB20072012 "Low Density Polyethylene Medical Eye Drop Bottles": a precise amount of 20mL of the test solution, precise addition of 20mL of potassium permanganate titrant (0.002mol/L) and Dilute sulfuric acid 1mL, boil for 3 minutes, quickly cool, add 0.1g potassium iodide, place in a dark place for 5 minutes, titrate with sodium thiosulfate titrant (0.01mol/L) to light brown, and then drop 5 drops of starch indicator solution Titrate to colorless, take another blank solution of water and operate in the same way. Do a blank test at the same time. The difference between the two consumption of sodium thiosulfate titrant should not exceed 1.5mL.

The eye drop bottle is used as a pharmaceutical package that directly contacts the eye. If the easy oxide exceeds the standard, it will cause the deterioration of the medicine and affect the patient's eye health. The quality and safety of pharmaceutical packaging materials and their compatibility with drugs have a very important impact on drug safety. In order to protect people's drug safety, manufacturers of pharmaceutical packaging materials should pay attention to their quality control.