Specifications: 50-1000ML

Standard number: YB/QESC(02)113-2016

Product registration certificate number:

Drug packaging product registration number: B20180000580

Class I alkali-resistant borosilicate glass infusion bottle
National drug packaging character 20170168

Sodium bicarbonate injection is a direct intravenous infusion for the clinical treatment of metabolic acidosis and alkalizing urine. Currently, it is mainly packaged in glass bottles and non-PVC multilayer co-extruded films on the market. For highly alkaline sodium bicarbonate injection, using ordinary sodium-calcium infusion bottles poses a high risk of glass flaking during the product's shelf life. Although general class I borosilicate glass bottles are better than sodium-calcium glass, they cannot fundamentally solve the flaking risk of sodium bicarbonate injection, as both can only achieve alkali resistance at the "level. The use of multilayer co-extruded films presents many inconveniences in production processes and quality assurance, such as the potential for exceeding drug quality indicators during storage and sterilization. The industry urgently needs to invent alkali-resistant glass bottles for the filling of sodium bicarbonate injection. To develop a glass packaging product suitable for sodium bicarbonate injection, our company has conducted nearly three years of product trial production and validation, ultimately developing the Class I alkali-resistant borosilicate glass infusion bottle. Through accelerated experiments and drug stability tests within the product's shelf life, all test indicators meet the relevant requirements.

According to product testing and stability tests, the Class I alkali-resistant borosilicate glass infusion bottle has the following characteristics:

Meets the quality requirements specified in the current version of the United States Pharmacopeia USP<660>, European Pharmacopoeia Ph.Eur 3.2.1, and CFDAYBB standards, including product water resistance, heavy metal ion leaching, etc.
Meets IS04802-2 & IS04802-1 (Water resistance Class I requirements).
Meets YBB00352004-2015 (Glass resistance to boiling mixed alkali solution leaching test method) and IS0695:1991 alkali resistance Class I requirements. According to tests conducted by the Shandong Pharmaceutical Glass Quality Inspection Center and the Guangdong Provincial Drug Packaging Materials Product Quality Inspection Center, the test values ranged between 52-62mg/dm.².
Linear thermal expansion coefficient: 5.3~5.6x10-(20-300 degrees Celsius)
Through accelerated and stability tests conducted by several relevant drug packaging testing centers, it was found that: the number of insoluble particles in the simulated liquid of the alkali-resistant borosilicate glass infusion bottle did not show a significant increase compared to the blank sample; no obvious visible foreign matter was found in both the simulated liquid of the alkali-resistant borosilicate glass infusion bottle and the blank sample; the pH value of the simulated liquid of the alkali-resistant borosilicate glass infusion bottle did not show significant changes compared to the blank sample; the conductivity value of the simulated liquid of the alkali-resistant borosilicate glass infusion bottle did not show significant changes compared to the blank sample; the content of chromium, boron, aluminum, potassium, silicon, and cerium elements in the simulated liquid of the alkali-resistant borosilicate glass infusion bottle increased compared to the blank sample; the content of barium, magnesium, antimony, lead, cadmium, and calcium elements in both the blank sample and the simulated liquid of the alkali-resistant borosilicate glass infusion bottle was below the reporting limit. After the tests, no significant flaking or erosion phenomena were observed in the selected areas recorded by observation and photography.

Through relevant inspections and tests, it has been proven that its alkali resistance is higher than that of borosilicate glass infusion bottles. In compatibility tests, the migration of relevant ions meets the requirements. No flaking occurred during the accelerated tests of filling sodium bicarbonate injection. The results of stability tests conducted by formulation companies for filling sodium bicarbonate injection meet the requirements, making it suitable for packaging of sodium bicarbonate injection and other alkaline preparations. Our company is currently processing the registration of this product on the National Drug Review Center's raw and auxiliary packaging information platform and is actively cooperating with customers to carry out compatibility and related review work.