Extractable matter testing of caps for effervescent tubes

As an important part of the packaging, the cap of the effervescent tube is of great significance to the overall sealing and moisture resistance of the packaging. In addition, as the material in direct contact with the drug, the dissolution test must be carried out to ensure that the material does not contain ingredients that affect the safety and stability of the drug.

144mm*29mm effervescent tube packaging

caps for effervescent tube

In China, the standard implemented for effervescent tube caps is YBB00172004-2015 "Quality Standard for Oral Solid Medicinal Low Density Polyethylene Moisture-Proof Combination Caps". The dissolution test in the standard mainly includes three items: easy oxides, nonvolatiles and heavy metals Detection:

Accurately measure 20ml of water test solution for easy oxide, accurately add 20ml of potassium permanganate titration solution (0.002mol/L) and 1ml of dilute sulfuric acid, boil for 3 minutes, cool rapidly, add 0.1g of potassium iodide, and place in a dark place for 5 minutes. Titrate with sodium thiosulfate titration solution (0.01mol/L), when the titration is near the end point, add 5 drops of starch indicator solution, continue to titrate until it is colorless, and take another water blank solution and operate in the same way, both of which consume sodium thiosulfate titration solution. (0.01mo/L) The difference should not exceed 1.5ml.

Non-volatile matter Precisely measure 50ml of water, 65% ethanol, n-hexane test solution and blank solution, respectively, and place them in an evaporating dish with constant weight, evaporate to dryness in a water bath, and dry at 105 °C for 2 hours. The difference between the non-volatile residue of the test solution and the residue of the blank solution should not exceed 12.0 mg: the difference between the non-volatile residue of 65% ethanol and the residue of the blank solution should not exceed 50.0 mg: the difference between the non-volatile residue of n-hexane and the residue of the blank solution should not exceed 50.0 mg. 200.0 mg·

Heavy metals: Precisely measure 20ml of water as test solution, add 2ml of acetate buffer (pH3.5), and check according to the law (the first method of Chinese Pharmacopoeia 2015 edition general rule 0821), and the heavy metal content shall not exceed one millionth.

The dissolution test of effervescent tube caps is an important test item to ensure the quality of packaging. Xinfuda has been engaged in drug packaging for 20 years, and its products have passed ISO15378 certification, US DMF filing and other certifications. If you are choosing packaging for drugs, Welcome to contact us.