QB/T 2945-2012Oral rinses (English PDF)

5.1 Fragrance

Smell to identify the fragrance.

5.2 Clarity

At room temperature and under natural lights, pour 25 ml of sample into the color comparison tube. Observe with naked eyes at a distance of 30 cm from the tube.

5.3 Stability

5.3.1 Instruments

a) Constant temperature incubator: accuracy is ±1°C;

b) Refrigerator: accuracy is ±1°C;

c) Color comparison tube with stopper: 50 ml.

5.3.2 Heat-resistance stability

Pour 25 ml of sample into the color comparison tube. Place it in the constant temperature incubator at (40±1)°C for 24 h. Take it out and recover to room temperature. Observe it with naked eyes.

5.3.3 Cold-resistance stability

Pour 25 ml of sample into the color comparison tube. Place it in the refrigerator at 0°C~4°C for 24 h. Take it out and recover to room temperature. Observe it with naked eyes.

5.4 pH

5.4.1 Apparatus

The following apparatus are used in the test:

a) pH meter: accuracy is 0.02 pH units;

b) Thermometer: accuracy is 0.2°C;

c) Balance: accuracy is 0.01 g.

5.4.2 Measurement methods

For normal-type products: Directly place 20 ml of sample into the 50 ml beaker to make electrodes immersed. Use pH meter to measure at 25°C.

For concentrated-type products: Weigh 5 ml of sample to dissolve in water. Use

5.5.4 Determination of free fluorine

Pipette 10 ml of test solution into 50 ml volumetric flask. Add 5 ml of citrate buffer. User ionized water to dilute to the scale. Move to 50 ml plastic beaker.

Under magnetic stirring, measure its potential value. Check the corresponding fluorine content on the standard curve. Calculate the concentration.

5.5.5 Determination of soluble fluorine

Pipette 0.5 ml of test solution. Move into 2 ml microcentrifuge tube. Add 0.7 ml of 4 mol/L hydrochloric acid. Cover the centrifuge tube. Perform water bath for

10 min at 50°C. Move to 50 ml volumetric flask. Add 0.7 ml of 4 mol/L sodium hydroxide to neutralize. Add 5 ml of citrate buffer. Use ionized water to dilute to the scale. Move to 50 ml plastic beaker. Under magnetic stirring, measure its potential value. Check the corresponding fluorine content on the standard curve.

Calculate the concentration.

5.5.6 Calculation

Calculate free fluorine and soluble fluorine according to formula (1) and formula (2), respectively.

Where, anti logc - logarithm of fluorine content checked on standard curve, then take the opposite.

Convert the above calculation results into mass fractions.

5.5.7 Representation and determination of results

The allowable error of two parallel determination results is 5%. Take the arithmetic mean of the two tests as the measurement result.

5.6 Fluoride ion content

Fluoride ion content X is calculated according to formula (3):

Where,

X - Fluoride ion content in oral rinses, in milligrams per bottle (mg/bottle);

Free fluorine

Soluble fluorine c) Manufacturer name, address;

d) Reference to the standard used;

e) Fragrance;

f) Instructions for use;

g) Shelf life, production date or restricted use date and production batch;

h) Fluorine-containing mouthwash shall indicate the amount of fluorine added. Fluorine-containing mouthwash for children shall be marked with warning text;

i) Product composition, in accordance with GB 8372.

7.1.2 The outer packaging shall have the following marks:

a) Product name, trademark;

b) Manufacturer name, address;

c) Packing quantity, gross weight;

d) Production date or restricted use date, production batch;

e) Packaging box specifications meet the requirements of GB/T 191.

7.2 Packaging

Without affecting the product quality, the product’s packaging form and packaging materials are customized by the enterprise. The inner packaging materials that are in contact with the contents of the product shall comply with the relevant health and safety requirements.

7.3 Transport

Use clean means of transport to carry goods. Put goods carefully. Unload goods with care. Stack according to the arrow sign on the box. Avoid violent vibration, impact. Keep from solarization and rain.

7.4 Storage

Store the products in dry warehouse with good ventilation. Do not make them near fire and heating. Stack according to the arrow sign on the box. Do not make them upside down.

7.5 Shelf life

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