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Determination of tretinoin and isotretinoin in cosmetics -- High performance liquid chromatography
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Basic data
| Standard ID | GB/T 30940-2014 (GB/T30940-2014) |
| Description (Translated English) | Determination of tretinoin and isotretinoin in cosmetics -- High performance liquid chromatography |
| Sector / Industry | National Standard (Recommended) |
| Classification of Chinese Standard | Y42 |
| Classification of International Standard | 71.100.70 |
| Word Count Estimation | 10,179 |
| Date of Issue | 7/8/2014 |
| Date of Implementation | 11/1/2014 |
| Quoted Standard | GB/T 6682 |
| Regulation (derived from) | 2014 National Standards Bulletin No. 18 |
| Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China |
| Summary | This standard specifies the method of liquid chromatography cosmetics retinoic acid and isotretinoin. This standard applies to the determination of skin care cosmetics category in retinoic acid and isotretinoin. The standard for Accutane and isotretinoin |
GB/T 30940-2014: Determination of tretinoin and isotretinoin in cosmetics -- High performance liquid chromatography
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Determination of tretinoin and isotretinoin in cosmetics - High performance liquid chromatography
ICS 71.100.70
Y42
National Standards of People's Republic of China
Retinoic acid, banned substances in cosmetics,
Determination of isotretinoin. High performance liquid chromatography
Released on.2014-07-08
2014-11-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Issued by the National Standardization Administration of China
Retinoic acid, banned substances in cosmetics,
Determination of isotretinoin. High performance liquid chromatography
1 Scope
This standard specifies the method for the determination of retinoic acid and isotretinoin in cosmetics by liquid chromatography.
This standard applies to the determination of retinoic acid and isotretinoin in skin care cosmetics.
The detection limit of this standard for retinoic acid and isotretinoin is 1.0 mg/kg, and the limit of quantification is 3.0 mg/kg.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
3 Method summary
Using methanol as solvent, ultrasonic extraction, centrifugation, 0.45μm organic filter membrane filtration, liquid chromatography detection, external standard method for quantification.
4 Reagents and materials
Unless otherwise specified, the reagents used are of analytical grade, and the water is the first grade water specified in GB/T 6682.
4.1 Methanol. chromatographically pure.
4.2 Glacial acetic acid.
4.3 Dichloromethane.
4.4 Standard stock solution of retinoic acid. accurately weigh 0.01g of retinoic acid, accurate to 0.0001g, and add an appropriate amount of retinoic acid to a 50mL brown volumetric flask.
The alcohol was dissolved by ultrasonic, and the volume was adjusted to the mark with methanol to obtain a standard stock solution with a concentration of retinoic acid solution of.200 mg/L. Refrigerator protects from light
Save it and use it for 2 months.
4.5 Isotretinoin standard stock solution. accurately weigh 0.01g isotretinoin, accurate to 0.0001g, and place it in a 50mL brown volumetric flask.
Dissolve the volume of methanol ultrasonically, and dilute to volume with methanol to obtain a standard stock solution with a concentration of.200 mg/L of isotretinoin solution. Refrigerator to avoid light and cold
It can be used for 2 months in storage.
4.6 Standard working solution. Pipette the above two standard stock solutions (4.4) and (4.5) respectively, and use methanol to make 0.15mg/L~50.0mg/L
The mixed standard working solution is ready to use.
4.7 The CAS number, molecular formula, relative molecular mass and structural formula of retinoic acid and isotretinoin are shown in Table A.1 of Appendix A.
5 Apparatus and equipment
5.1 Analytical balance. Sensitivity 0.0001g.
5.2 High performance liquid chromatograph with diode array detector.
5.3 Ultrasonic cleaner.
5.4 Centrifuge.
5.5 Graduated centrifuge tube. 10mL.
6 Analysis steps
6.1 Sample preparation
Weigh 0.5g of cosmetic sample (accurate to 0.001g) into a 10mL graduated test tube, add methanol and dilute to the mark, vortex and shake
Swing until the sample is evenly dispersed, ultrasonically extract for 10min, 6500r/min, centrifuge for 10min, filter the supernatant through a 0.45μm filter membrane, and filter the filtrate
To be tested.
6.2 Determination
6.2.1 Reference conditions for liquid chromatography
The reference conditions for liquid chromatography determination are as follows.
a) Chromatographic column type. C18 column (250mm×4.6mm particle size. 5μm); or chromatographic column with equivalent performance;
b) Sample injection volume. 10μL;
c) Mobile phase. A. 0.5% glacial acetic acid methanol solution (5mL glacial acetic acid added to 1000mL methanol); B. 0.5% glacial acetic acid aqueous solution
(Add 5mL glacial acetic acid to 1000mL water);
d) Mobile phase flow rate. 1.0mL/min;
e) Measurement wavelength. 358nm;
f) See Table 1 for gradient elution conditions.
Table 1 Gradient elution conditions
6.2.2 Determination
Use the prepared standard working solution (4.6) to draw a standard working curve, and use the standard working curve to quantify the sample, which exceeds the linear range
Then it should be diluted and then injected for analysis. Refer to Figure B.1 and Figure B.2 in Appendix B for the chromatogram and spectrum of the reference material.
7 Result calculation
The content of the component to be tested in the sample is calculated according to formula (1).
8 Limit of detection and limit of quantification
The detection limit of this standard for retinoic acid and isotretinoin is 1.0 mg/kg, and the limit of quantification is 3.0 mg/kg.
9 Recovery rate and precision
The additive concentration is in the range of 3mg/kg~1000mg/kg, the recovery rate of addition is between 90%~105%, and the relative standard deviation is small
Less than 10%.
10 allowable difference
The absolute difference between two independent determination results obtained under repeated conditions shall not exceed 10% of the arithmetic mean.
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