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Quality Standard of Gelatin Capsule

Views:166     Author:Site Editor     Publish Time: 2021-04-25      Origin:Site


This product is a hollow hard capsule made by empty capsules filling machine or gelatin capsule machine with gelatin and accessories. The capsule body of powder capsule making should be smooth, uniform color, smooth incision, no deformation and odor.

 

45-2-capsule filling machine 


1. Identification

(1) Take 0.25g of this product, and add 50ml of water, heating to dissolve, then cool down and shake well. Take 5ml of solution and add a few drops of mixed solution of potassium chromate test solution and dilute hydrochloric acid (4:1). That will produce orange flocculent precipitation.

 

(2) Take 1ml of the remaining solution under identification item (1), add 50ml water,  and shake well. Add a few drops of tannic acid test solution, then turbidity occurs.

 

(3) Take about 0.3g of this product, and put it in the test tube, then add a little soda lime. The generated gas can make the wet red litmus test paper turn blue.

 

Capsule machines include soft gelatin capsule filling machine, hard gelatin capsule filling machine, dosator capsule filling machine, etc.

 

 

2. Inspection

(1) PH Value

Take 1.0g of this product and add 100ml hot-water. Shake and make it dissolved. Then cool the solution to 35 ℃, and pH value should be 4.0-7.2.

 

(2) Disintegration Time Limit

Take 6 capsules of this product and fill it with talc powder. Add baffle plate for inspection according to the method of disintegration time limit inspection method for capsules. All granules should be dissolved or disintegrated within 10 minutes. If one capsule can not be completely dissolved or disintegrated, another 6 tablets should be taken for retest, all of which should meet the requirements.

 

(3) Sulfite (Measured by SO2)

Take 5.0g of this product, put it into a long neck round bottom flask, and add 100ml hot water to dissolve. Add 2ml phosphoric acid and 0.5g sodium bicarbonate and connect the condenser tube immediately. Take 15ml of 0.05mol/l iodine solution as the receiving liquid and collect 50ml of distillate, then add water to 100ml. Shake well. Measure 50ml, and evaporate on water bath. Add water at any time. Evaporate until the solution is almost colorless.

 

Add water to 40ml and check according to the sulfate test method. If it is turbid, it should not be thicker (0.01%) compared with the control solution made of 3.75ml standard potassium sulfate solution.

 

(4) Loss on Drying

Take 1.0g of this product, separate the capsule cap and body, and dry at 105 for 6 hours. The weight loss should be 12.5% ~ 17.5%.

 

(5) Residue on Ignition

Take 1.0g of this product and check according to the method. The residue should not exceed 2.0% (transparent), 3.0% (translucent) and 5.0% (opaque) respectively.

 

(6) Chromium

Take 0.50g of this product, put it into the Teflon digestion tank, add 5-10ml nitric acid and mix well. Soak overnight. Cover the inner cover and tighten the outer cover, then put it into the appropriate microwave digestion oven for digestion (operate according to the digestion procedure specified by the instrument). After the digestion is complete, take the digestion tank and place it on the electric heating plate, then slowly heat it until the reddish brown vapor is evaporated completely and nearly dry. Transfer it into a 50ml volumetric flask with 2% nitric acid, and dilute to the scale. Finally shake well.

 

The reagent blank solution was prepared by the same method at the same time. In addition, the chromium single element standard solution was diluted with 2% nitric acid to prepare chromium standard reference stock solution containing 1.0 μmg/ml chromium per 1ml. Before utilization, the appropriate amount of chromium standard reference stock solution was precisely measured and diluted with 2% nitric acid solution to prepare reference solution containing 0-80 ng/ml chromium per 1 ml.

 

Take the test solution and the reference solution, and take the graphite furnace as the quartzfurnaceatomizer. Determine at 357.9mm by atomic absorption spectrophotometry, and the chromium content shall not exceed 2 parts per million.

 

(7) Heavy Metals

Take the residue left under the item of residue on ignition. According to the method of inspection, the content of heavy metal shall not exceed 40 parts per million.

 

(8) Viscosity

Take 4.50g of this product, put it into a 100ml beaker with fixed weight, add 20ml of warm water, and stir in 60 water bath to dissolve. Take out the beaker, dry the outer wall, and add water to make the total weight of glue solution reach the weight of the following formula (including 15.0% dried products). After mixing the glue solution evenly, pour it into a dry conical bottle with stopper. Plug it tightly, and put it into a 40℃+0.1℃ water bath. After about 10 minutes, move it into the Pinker viscometer. According to the viscosity determination method (Capillary inner diameter is 2.0 mm), the kinematic viscosity of the product shall not be less than 60mm2/s.

 

Total weight of glue solution (g) = (1-loss on drying) * 4.50 * 100 / 15.0

 

 

3. Microbial limit

The total number of aerobic bacteria in 1g of test sample was no more than 1000cfu. The total number of molds and yeasts was less than 100cfu, and no Escherichia coli was detected. Salmonella should not be detected in every 10 g of the test sample.

 

The empty automatic capsules should be stored in airtight condition at 10℃-25℃ and relative humidity of 35%-65%.

 

Capsules can be made of capsule filling machine, including gel capsule filling machine, automatic capsule filling machine, etc.


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