QB/T 2945-2012 English PDF (QBT2945-2012)

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QB/T 2945-2012: Oral rinses
QB/T 2945-2012
LIGHT INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 71.100.40
Classification No.: Y 43
File No.: 39413-2013
Replacing QB/T 2945-2008
Oral rinses
ISSUED ON: DECEMBER 28, 2012
IMPLEMENTED ON: JUNE 01, 2013
Issued by: Ministry of Industry and Information Technology of the
People's Republic of China
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Product classifications ... 5 
4 Requirements ... 5 
5 Test methods ... 6 
6 Inspection rules ... 10 
7 Marks, packaging, transport, storage, shelf life ... 11 
Oral rinses
1 Scope
This Standard specifies classifications, requirements, test methods, inspection
rules and marks, packaging, transport, storage as well as shelf life for oral
rinses.
This Standard is applicable to various liquid products used for oral cleaning and
care, such as mouthwash and oral spray.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 191, Packaging and storage marks
GB/T 601, Chemical reagent - Preparations of standard volumetric solutions
GB/T 602, Chemical reagent - Preparations of stock standard solutions
GB/T 603, Chemical reagent - Preparations of reagent solutions for use in
test methods
GB/T 6682, Water for laboratory use - Specifications
GB 8372, Toothpaste
GB 22115, General requirements on raw materials of toothpastes
JJF 1070-2005, Rules of Metrological Testing for Net Quantity of Products in
Prepackages with Fixed Content
No. 75 Order of General Administration of Quality Supervision, Inspection
and Quarantine [2005], Quantitative Packaging Commodity Measurement
Supervision and Management Measures
Ministry of Health of the People's Republic of China, Cosmetic hygiene
specification (2007)
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