GB/T 26367-2020 PDF English (GB 26367-2010: Older version)
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Hygienic requirements for biguanides disinfectants
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[GB/T 26367-2010] Hygienic standard for biguanides disinfectants
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GB/T 26367-2020: PDF in English (GBT 26367-2020) GB/T 26367-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Replacing GB/T 26367-2010
Hygienic requirements for biguanides disinfectants
ISSUED ON: JUNE 02, 2020
IMPLEMENTED ON: DECEMBER 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Raw material requirements ... 5
5 Technical requirements ... 6
6 Application range ... 7
7 Method of use ... 8
8 Inspection method ... 8
9 Transportation, storage and packaging ... 8
10 Marking requirements ... 9
Appendix A (Normative) Determination method of chlorhexidine acetate,
chlorhexidine gluconate and chlorhexidine hydrochloride ... 10
Appendix B (Normative) Method for determination of polyhexamethylene mono-
biguanide and polyhexamethylenebiguanide ... 16
Hygienic requirements for biguanides disinfectants
1 Scope
This standard specifies the raw material requirements, technical requirements,
application scope, use methods, transportation, storage and packaging,
marking requirements, inspection methods of biguanides disinfectants.
This standard applies to disinfectants that use chlorhexidine,
polyhexamethylene biguanides and other biguanides raw materials as the main
bactericidal ingredients, and ethanol and (or) water as the solvent.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) is applicable to this standard.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 6682 Water for analytical laboratory use - Specification and test
methods
GB 27950 General requirements for hand disinfectant
GB 27951 Hygiene requirements for skin disinfectant
GB 27954 General requirements for disinfectant of mucous membrane
WS 628 Technical requirements for the hygiene and safety evaluation of
disinfectant products
Pharmacopoeia of the People's Republic of China (Part 2)
Disinfection technical specifications (2002 edition) [Ministry of Health (WFJF
[2002] No.282)]
Sanitary specification for disinfection product manufacturers (2009 Edition)
[Ministry of Health (WJDF [2009] No.53)]
Notice of the Ministry of Health on issuing the regulations on the limit values
of certain ingredients in skin and mucous membrane disinfectants [Ministry
4.1.3 Ethanol
It shall comply with the "Pharmacopeia of the People's Republic of China" (Part
2).
4.2 Production water
The production water shall meet the requirements of Article 30 of the "Sanitary
specification for disinfection product manufacturers" (2009 edition).
5 Technical requirements
5.1 Physical and chemical indicators
5.1.1 Active ingredient content
The content of the effective ingredients of the disinfectant shall meet the
indicated content. Chlorhexidine disinfectants used in hand and skin
disinfection shall meet the requirements of GB 27950, GB 27951, "Notice of the
Ministry of Health on issuing the limit values of certain ingredients in skin and
mucosal disinfectants"; the specified use concentration of chlorhexidine
gluconate or chlorhexidine acetate shall be less than or equal to 45 g/L; the
chlorhexidine disinfectant used for mucosal disinfection shall meet the
requirements of GB 27954 and the "Notice of the Ministry of Health on issuing
the limit values of certain ingredients in skin and mucosal disinfectants"; the use
concentration of chlorhexidine or chlorhexidine acetate shall be less than or
equal to 5 g/L; the use concentration of polyhexamethylenebiguanides
disinfectant shall be less than or equal to 3 g/L.
5.1.2 Stability
The validity period is more than 12 months. The reduction rate of the effective
ingredient content of the disinfectant shall be less than or equal to 10%,
meanwhile the effective ingredient content after storage shall not be lower than
the lower limit of the content specified by the product's corporate standard.
The validity period is more than 24 months. The reduction rate of the effective
ingredient content of the disinfectant shall be less than or equal to 10%,
meanwhile the effective ingredient content after storage shall not be lower than
the lower limit of the content specified in the product's corporate standard.
5.1.3 Limits of lead, mercury, arsenic
Disinfectants used for hands, skin, mucous membranes shall have the following
requirements: lead shall be less than or equal to 10 mg/kg, mercury shall be
less than or equal to 1 mg/kg, arsenic shall be less than or equal to 2 mg/kg.
7 Method of use
Use methods such as wiping, soaking, rinsing, foam retention for disinfection.
8 Inspection method
8.1 Active ingredient content
8.1.1 See Appendix A for the determination of chlorhexidine acetate,
chlorhexidine gluconate, chlorhexidine hydrochloride.
8.1.2 See Appendix B for the determination of the content of
polyhexamethylenebiguanide and polyhexamethylene mono-biguanides.
8.2 Stability test
It is stored in accordance with the method for determining the stability of
disinfection products in the "Technical specifications for disinfection" (2002
edition); the content of active ingredients is determined in accordance with
Appendix A or Appendix B.
8.3 Determination of lead, mercury, arsenic limits
Make determination according to the related methods of "Cosmetic safety
technical specification" (2015 edition).
8.4 Test for killing microorganisms
It shall comply with the provisions of "Disinfection technical specifications"
(2002 edition).
9 Transportation, storage and packaging
9.1 Transportation
It shall be airtight during transportation. Anticorrosion is required for shipping
containers. It shall be handled with care and throwing is strictly prohibited. It
shall be protected from sun, rain and moisture during transportation.
9.2 Storage
Store in a dry and dark place at room temperature. The packaging shall be tight
and prevent moisture. The stack shall be more than 10 cm above the floor; the
height of the stack shall not exceed 12 boxes; the distance from the wall shall
be more than 20 cm.
Appendix A
(Normative)
Determination method of chlorhexidine acetate, chlorhexidine gluconate
and chlorhexidine hydrochloride
A.1 Method 1: High-performance liquid chromatography
A.1.1 Overview
This method is suitable for single and compound disinfectants containing
chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride.
A.1.2 Principle
The samples are extracted by mobile phase ultrasonic wave, measured by high
performance liquid chromatography-diode array detector, quantified by peak
area external standard method.
A.1.3 Reagents or materials
Unless otherwise stated, the reagents used in this method are analytically pure;
the experimental water is the first-grade water as specified in GB/T 6682.
A.1.3.1 Chlorhexidine acetate (C22H30Cl2N10·2C2H4O2, CAS number: 56-95-1)
standard product.
A.1.3.2 Potassium dihydrogen phosphate (KH2PO4).
A.1.3.3 85% phosphoric acid (H3PO4).
A.1.3.4 Acetonitrile (CH3CN): chromatographically pure.
A.1.4 Instruments
A.1.4.1 High performance liquid chromatograph with diode array detector.
A.1.4.2 Electronic balance with a sensitivity of 0.1 mg.
A.1.4.3 Ultrasonic cleaner.
A.1.5 Test procedure
A.1.5.1 Preparation of mobile phase and extract
Weigh 2.7 g of potassium dihydrogen phosphate. Put it into a 1000 mL
graduated cylinder. Add about 950 mL of water to dissolve it. Add 1.5 mL of 85%
phosphoric acid. Then add water to make the volume reach to 1000 mL. Mix
A.1.6 Test data processing
According to the standard curve, calculate the content of chlorhexidine acetate
in the sample. The calculation is as shown in formula (A.1):
Where:
X - The content of chlorhexidine acetate in the sample, in grams per kilogram
(g/kg) or grams per liter (g/L);
ρ - The mass concentration of chlorhexidine acetate in the sample solution
obtained from the standard curve, in milligrams per liter (mg/L);
V - Constant volume, in milliliters (mL);
m - The sample amount, in grams (g) or milliliters (mL).
Note: The determination of chlorhexidine gluconate content can use chlorhexidine
acetate as the standard; the result is multiplied by 1.4352.
For the determination of chlorhexidine hydrochloride content, chlorhexidine acetate
can be used as the standard; the result is multiplied by 0.9246.
A.1.7 Precision
The absolute difference between two independent test results obtained under
repeatability conditions is not more than 10% of the arithmetic mean.
A.2 Method 2: Titration
A.2.1 Overview
This method is based on the determination method of chlorhexidine acetate in
the Pharmacopoeia of the People's Republic of China (Part 2). It is suitable for
simple-recipe disinfectants containing chlorhexidine acetate.
A.2.2 Principle
Use acetone and glacial acetic acid do dissolve the sample. Add methyl orange
saturated acetone solution. Use perchloric acid titrant for titration. Stop the
titration when the methyl orange indicator solution turns orange. Calculate the
chlorhexidine acetate content by using the perchloric acid titrant .
A.2.3 Reagents or materials
Unless otherwise stated, the reagents used in this method are analytically pure;
A.2.7 Precision
The absolute difference between two independent determination results
obtained under repeatability conditions is not more than 10% of the arithmetic
mean.
A.3 Method 3: Ultraviolet spectrophotometry
A.3.1 Overview
This method is based on the determination method of chlorhexidine acetate
ointment in the Pharmacopoeia of the People's Republic of China (Part 2). It is
suitable for ointment or liquid preparation simple-recipe disinfectant containing
chlorhexidine (including chlorhexidine acetate, chlorhexidine gluconate,
chlorhexidine hydrochloride).
A.3.2 Principle
The matrix in chlorhexidine acetate in the sample is dissolved in chloroform and
then extracted by 1.5 mol/L acetic acid solution. The absorbance value is
determined at a wavelength of 260 nm to quantify it.
A.3.3 Reagents or materials
Unless otherwise stated, the reagents used in this method are analytically pure;
the experimental water is the grade-1 water as specified in GB/T 6682.
A.3.3.1 Chlorhexidine acetate (C22H30Cl2N10·2C2H4O2, CAS number: 56-95-1)
standard product.
A.3.3.2 Chloroform (CHCl3).
A.3.3.3 Glacial acetic acid (CH3COOH).
A.3.4 Instruments
A.3.4.1 Ultraviolet spectrophotometer.
A.3.4.2 Electronic balance with a sensitivity of 0.1 mg.
A.3.5 Test procedure
A.3.5.1 Standard solution determination
Accurately weigh about 10 mg of the standard chlorhexidine acetate. Put it in a
100 mL volumetric flask. Add 1.5 mol/L acetic acid solution to dissolve and dilute
to the mark. Shake well. Accurately measure 5 mL. Place it in a 50 mL
measuring flask. Use ethanol to dilute it to the mark. Measure the absorbance
Appendix B
(Normative)
Method for determination of polyhexamethylene mono-biguanide and
polyhexamethylenebiguanide
B.1 Method 1: Visible spectrophotometry
B.1.1 Overview
This method is suitable for single-recipe disinfectants containing
polyhexamethylene mono-biguanides and polyhexamethylenebiguanide.
B.1.2 Principle
Polyhexamethylene mono-biguanides (PHMG) and
polyhexamethylenebiguanide (PHMB) can react with Eosin Y; the color
changes from orange to pink; the absorbance value is measured at a
wavelength of 545 nm. The absorbance value is directly proportional to PHMG,
PHMB content.
B.1.3 Reagents or materials
Unless otherwise stated, the reagents used in this method are analytically pure;
the experimental water is the grade-1 water as specified in GB/T 6682.
B.1.3.1 Polyhexamethylene biguanide hydrochloride [PHMB, (C8H17N5)n ·xHCl]
standard product, polyhexamethylene mono-biguanides hydrochloride
standard product [PHMG, (C7H16N3)n ·xHCl, which may be raw materials with a
purity greater than 95%].
B.1.3.2 Eosin Y (C20H6Br4Na2O5).
B.1.3.3 Sodium acetate trihydrate (CH3COONa·3H2O).
B.1.4 Instruments
B.1.4.1 Visible light spectrophotometer, 5 cm cuvette.
B.1.4.2 Electronic balance with a sensitivity of 0.1 mg.
B.1.5 Test procedure
B.1.5.1 Preparation of indicator solution
m - The sample amount, in grams (g) or milliliters (mL).
B.1.7 Precision
The absolute difference between two independent determination results
obtained under repeatability conditions is not more than 10% of the arithmetic
mean.
B.2 Method 2: Ultraviolet spectrophotometry
B.2.1 Overview
This method is suitable for single-recipe disinfectants containing
polyhexamethylenebiguanide.
B.2.2 Principle
Polyhexamethylene biguanide has ultraviolet absorption at 234 nm; the
absorbance value is proportional to the PHMB content within a certain
concentration range.
B.2.3 Reagents or materials
Unless otherwise specified, the experimental water is the grade-1 water as
specified in GB/T 6682.
Polyhexamethylenebiguanide hydrochloride [PHMB, (C8H17N5)n·xHCl]
standard product.
B.2.4 Instruments
B.2.4.1 UV spectrophotometer, 1 cm quartz cuvette.
B.2.4.2 Electronic balance with a sensitivity of 0.1 mg.
B.2.5 Test procedure
B.2.5.1 Preparation of PHMB standard solution
Accurately weigh 10 mg of PHMB standard substance and use water to dilute
to 100 mL, to obtain a 100 mg/L standard solution.
B.2.5.2 Preparation of standard curve
Use water to dilute the standard solution into a standard series of 2 mg/L, 4
mg/L, 6 mg/L, 8 mg/L, 10 mg/L, 12 mg/L, 16 mg/L. Use a 1 cm quartz cuvette
to determine the absorbance value at 234 nm of the UV spectrophotometer;
meanwhile draw a standard curve.
used to separate and determine the active ingredients polyhexamethylene
mono-biguanides (PHMG), polyhexamethylene biguanide (PHMB),
chlorhexidine acetate (CHA) in disinfectants at the same time. Use the
calibration peak area external standard method for quantification.
B.3.3 Reagents or materials
Unless otherwise stated, the reagents used in this method are analytically pure;
the experimental water is the grade-1 water as specified in GB/T 6682.
B.3.3.1 Polyhexamethylenebiguanide hydrochloride [PHMB, (C8H17N5)n · xHCl]
standard product, polyhexamethylene mono-biguanides hydrochloride
standard product [PHMG, (C7H16N3)n · xHCl, which can be raw materials with
purity greater than 95%], chlorhexidine acetate (CHA, C22H30Cl2N10 · 2C2H4O2)
standard.
B.3.3.2 Sodium tetraborate (Na2B4O7·10H2O, > 99.5%).
B.3.3.3 Sodium hydroxide (NaOH): superior pure.
B.3.3.4 Sodium dodecyl sulfate (SDS, 99%).
B.3.3.5 Sodium deoxycholate (SD, 98%).
B.3.3.6 Polyethylene glycol 20000 (PEG20000).
B.3.4 Instruments
B.3.4.1 Capillary electrophoresis instrument with diode array detector (PDA).
B.3.4.2 Electronic balance with a sensitivity of 0.1 mg.
B.3.5 Test procedure
B.3.5.1 Preparation of standard solution
Accurately weigh 50 mg each of PHMG, CHA, PHMB; place them in a 15 mL
plastic centrifuge tube. Use a pipette to add 10 mL of water and vortex to mix
to obtain a standard stock solution with a mass concentration of 5 g/L. Store in
refrigerator at 4 °C.
B.3.5.2 Preparation of standard curve
Use sample solution to dilute the standard stock solutions of PHMG, PHMB,
CHA step by step, to respectively prepare them into 7.5 mg/L, 15 mg/L, 30 mg/L,
60 mg/L, 120 mg/L PHMG working solutions, PHMB and CHA mixed working
solution.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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