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GB/T 32122-2015: Determination of 12 nitroimidazoles in toothpaste -- HPLC and HPLC-MS/MS
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GB/T 32122-2015: Determination of 12 nitroimidazoles in toothpaste -- HPLC and HPLC-MS/MS

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Determination of 12 nitroimidazoles in toothpaste - HPLC and HPLC-MS/MS ICS 71.100.40 Y43 National Standards of People's Republic of China Determination of 12 kinds of toothpaste nitroimidazoles drugs High performance liquid chromatography and liquid chromatography tandem mass spectrometry HPLCandHPLC-MS/MS Issued on. 2015-10-09 2016-05-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. The standard proposed by China National Light Industry Council. The standard oral care products by the National Technical Committee of Standardization Technical Committee toothpaste (SAC/TC492/SC1) centralized. This standard was drafted. Dalian City Product Quality Supervision, Inspection (National Day of Product Quality Supervision and Inspection Center), Dalian Standard Testing Technology Art research center. The main drafters of this standard. Maoxi Qin, Zheng Shunli, Renguo Jie, Zhang Cui, Li Chunling, Gu Xinrong, Li Peng, Dongguang Bin.

Introduction

This standard specifies the 12 nitroimidazoles are prohibited substances of "oral care product raw material specifications" set forth, Not be used as raw material, component toothpaste added to toothpaste. If technically impossible to avoid these prohibited substances as impurities into toothpaste , The finished product should be consistent with the toothpaste "oral care products with raw material specifications" requirement that under normal and reasonably foreseeable conditions of use, Must not cause harm to human health. At present, China has not yet specified limit values \u200b\u200bfor these substances are present as impurities. The standards, measuring only toothpaste mention these substances For detection methods. Determination of 12 kinds of toothpaste nitroimidazoles drugs High performance liquid chromatography and liquid chromatography tandem mass spectrometry

1 Scope

This standard specifies the 12 kinds of toothpaste nitroimidazoles (Table 1) high performance liquid chromatography and liquid chromatography tandem determined Mass spectrometry. This standard applies to the determination of the above 12 kinds of toothpaste nitroimidazoles drugs. HPLC method detection limits (for all targets). 3μg/g, lower limit of quantification (for all targets). 10μg/g; liquid chromatography Spectrum tandem mass spectrometry detection limit (for all targets). 0.3μg/g; lower limit of quantification (for all targets) 1μg/g.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 6379.1 measurement methods and results of Accuracy (trueness and precision) - Part 1. General principles and definitions GB/T 6379.2 measurement methods and results of Accuracy (trueness and precision) - Part 2. Determine the standard measurement method to repeat Of the basic methods of reproduction Laboratory use specifications and test methods GB/T 6682 Analysis Method 3 points Toothpaste with a saturated saline solution and scroll through ultrasonic dispersion treatment with acetonitrile (containing antioxidant) twice to extract the object compound were combined twice Acetonitrile extract and after constant volume, take part extract of nitrogen and solvent evaporated to dryness and washed with 3% aqueous formic acid ultrasound after reconstitution, reversed phase and cation Mixing mechanism SPE column with 3% aqueous formic acid leaching bed, with 2% aqueous ammonia ammoniated methanol (containing stabilizer) eluting target eluting Washed with 3% aqueous formic acid and constant volume, the Vortex. By liquid chromatography or liquid chromatography tandem mass spectrometry, a standard curve outside Standard method. By liquid chromatography test, the result is positive samples need to be confirmed by liquid chromatography tandem mass spectrometry.

4 standard materials and reagents

Unless otherwise specified, the reagents were of analytical grade water to comply with GB/T 6682 with a water laboratory. 4.1 acetonitrile. chromatography (chromatographic mobile phase preparation) 4.2 formic acid. chromatography (chromatographic mobile phase preparation) 4.3 methanol 4.4 formic acid The English name of the 4.5 standard substance, CAS number, molecular formula, molecular structure and molecular weight Table 1. ...