Pharmaceutical Packaging Compatibility Test-Migration Test

The extraction solvent used in the extraction test of the pharmaceutical packaging compatibility test is only similar to the preparation in terms of polarity, pH value and ionic strength, because it is not the actual prescription of the preparation, and the characteristics of the active ingredients or some auxiliary materials in the preparation , So that the interaction between the extraction solvent, the real preparation and the packaging material may be different, that is, the extractables obtained in the extraction test are inconsistent with the extracts obtained in the real preparation migration test.

pharma desiccant bottle
In addition, although some components in the packaging materials can be obtained in the extraction test, they will not migrate into the preparation in the migration test and stability test; but the extractable may be degraded or other Components react, and these degradation products or reaction products can migrate into the formulation. Therefore, based on the extraction test, the real preparation should still be used for migration test.

empty vitamin c tubes
Migration tests are used to monitor substances that migrate from the packaging material and enter the formulation. Usually through accelerated or long-term stability tests (note that the preparation should be in full contact with the packaging material) to increase the corresponding detection target compound (derived from the understanding of the packaging component material composition or the extractable information obtained by the extraction test) to obtain the drug The information of the extract contained in it includes the type and content level of the extract.

In addition, if the packaging material is composed of different layers of materials (3-layer and 5-layer co-extruded film bags), it is not only necessary to evaluate the possibility of the innermost component migrating into the drug, but also the middle and outer components should be considered. Possibilities in drugs; At the same time, it must also be proved that the ink or adhesive in the outer layer will not migrate into the drug. Semipermeable material packaging should be researched on the outer layer of ink or adhesive will not migrate into the drug.

More test for veterinary syringe

More test for veterinary syringe.

6.3 Adhesion

Take an appropriate amount of this product, add half of the water (or colored solution) to the needle tube, match the push rod to expel the air, ensure there is no air in it, wear good care

Cap, through the push rod, apply pressure 30N above the push rod piston for 30 seconds, there should be no leakage at the seal of the protective cap and the seal of the piston.

5ml syringe for cow mastitis

6.4 Lubricity

Take an appropriate amount of this product, insert the push rod (push rod with piston) into the needle tube, push the push rod into the entire needle tube, the push rod piston should move smoothly,

I think there is a sudden pause.

6.5 Residue on ignition *

Take 2.0g of the needle tube and determine it according to law ("General Regulations of the People's Republic of China Veterinary Pharmacopoeia 2015" Part Two 0841)

0.1% (the residue left by the bottle containing sunscreen should not exceed 3.0%).

candy tablet packaging requirement

The health care product candy tablet refers to the health care product produced by the candy tableting process, usually generally a tablet. The purpose of the tableting process for health care products is to make the health care products tablets have a better taste and improve the user's eating experience.

effervescent tablet packaging

The candy tableting industry is gradually adopting moisture-proof dry bottles. Plastic candy tubes has good sealing performance and integrates desiccant into the bottle cap, which can effectively prevent the tablets from coming into contact with the desiccant, and can achieve the purpose of absorbing water molecules, so as to keep the inside of the package dry.

desiccant cap

The health care product candy tablet packaging bottle cap has a small drug warehouse cardboard to separate the desiccant from the test strip to prevent direct contact between the direct desiccant and the tablet. The desiccant is on the top of the lid, and the lid is directly sealed with the bottle body without the need for a gasket. The cap is made by injection molding, and the bottle body is injection-blasted. The general capacity is less than 100ml. Printing can be done according to customer requirements. The clamshell seal increases consumer appeal and is ergonomically designed to encourage consumers to close the seal and extend protection.

Tirpinimo bandymas of plastic veterinary syringe

 Tirpinimo bandymas of plastic veterinary syringe:

Preparation of test solution: Take the internal surface area of this product (needle tube) 600cm2 (split into pieces of 5cm long and 0.3cm wide), set

Add appropriate amount of water to the conical flask, shake and wash the small pieces, discard the water, and repeat the operation twice. After drying at 30 ～ 40 ℃, use water (70 ℃ ± 2 ℃)

After soaking in 200ml for 24 hours, take it out and let it cool to room temperature, use the same batch of test solvent to make up the original volume as the test solution, and use the same batch of water as a blank

Liquid, perform the following tests:

6.6.1 pH change

Take 20ml each of the test solution and the water blank solution, add 1.0ml of potassium chloride solution (1 → 1000) respectively, and determine according to the law ("Chinese People's

"He Guoguo Pharmacopoeia" 2015 edition two general rules 0631) measured, the difference between the two pH value should not exceed 1.0.

dial a dose syringe

6.6.2 Heavy metals

Accurately take 20ml of water for the test solution, add 2ml of acetate buffer (pH 3.5), and determine according to the law ("Veterinary Pharmacopoeia of the People's Republic of China")

The 2015 edition of the General Principles of the Second Department (0821, Act 1), containing heavy metals shall not exceed one part per million.

6.6.3 Easy oxide

Accurately take 20ml of water for the test solution, add 20ml of potassium permanganate titration solution (0.002mol / L) and 1ml of dilute sulfuric acid, and boil for 3 minutes.

Quickly cool to room temperature. Add 0.1g potassium iodide, place in the dark for 5 minutes, titrate with sodium thiosulfate titration solution (0.01mol / L), titrate

To the near end, add 5 drops of starch indicator solution and continue titration until colorless. Take another water blank solution and operate in the same way, both consume sodium thiosulfate drops

The difference of fixed solution (0.01mol / L) should not exceed 1.5ml.

6.6.4 Non-volatile matter

Accurately take 50ml each of the test solution and the blank solution, put them in an evaporating dish with constant weight, evaporate to dryness in a water bath, and dry to constant weight at 105 ℃.

The difference between the two should not exceed 12.0mg.

Test conditions of plastic veterinary syringe

Test conditions of plastic veterinary syringe

1.1.1 Test environment

Temperature 0 ~ 30 ℃, relative humidity 30 ~ 75%.

1.1.2 Blank extraction

Sampling at the beginning of each batch of production, sampling according to the number of cavities in the mold to ensure that each cavity is taken.

plastic veterinary syringe

1.2 Appearance quality

Take an appropriate amount of this product. In a place where the natural light is bright, the observer's eyes are about 300mm away from the segment.

Requirements.

1.3 Adhesion

Take an appropriate amount of this product, add half of the water (or colored solution) to the needle tube, match the push rod to expel the air, make sure there is no air in it, wear good care

Cap, through the push rod, apply pressure 30N above the push rod piston for 30 seconds, there should be no leakage at the seal of the protective cap and the seal of the piston.