Application of metal inspection in packaging of effervescent tablets

Heavy metal detection is a routine test item in the quality standard of drug packaging, and this test is also involved in the quality standard of effervescent tablet packaging. So, what is the detection method?

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cap for effervescent tube

In the quality standard for the packaging of effervescent tablets, "Oral Solid Medicinal High Density Polyethylene Bottle", the requirements for heavy metals are as follows: Precisely measure 20ml of water for test solution, add 2ml of acetate buffer (pH3.5), according to the law Check (Chinese Pharmacopoeia 2015 Edition General Principle 0821 First Law), the heavy metal content should not exceed one millionth.

Detection method: Unless otherwise specified, take three 25ml Nessler colorimetric tubes, add a certain amount of standard lead solution and 2ml acetate buffer (pH3.5) to tube A, add water or the specified amount under each variety. Dilute the solvent to 25ml, add 25ml of the test solution prepared according to the method specified in each category to tube B, add the same weight of the test product to tube B, and add an appropriate amount of solvent to prepare the test solution. Dissolve, add 2ml of standard lead solution and acetate buffer (pH 3.5) in the same amount as tube A, and then dilute to 25ml with solvent; if the test solution is colored, add a small amount of dropwise to tube A Dilute the caramel solution or other non-interfering colored solution to make it consistent with tubes B and C; then add 2ml of thioacetamide test solution to tubes A, B, and C respectively, shake well, and let stand for 2 minutes. Put it on the same white paper and see through it from top to bottom. When the color displayed in tube C is not lighter than tube A, the color displayed in tube B should not be darker than tube A.

The above is the specific process of heavy metal detection in the packaging quality standard of effervescent tablets. Excessive heavy metals will lead to contamination of drugs and endanger human health, so this test must be strictly controlled to ensure packaging safety.