This standard specifies the limit and determination methods for 12 kinds of carcinogenic dyes (see Annex A) in dye products.
This standard is applicable to dye products of each dosage form.
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 6682-2008 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987, MOD)
GB/T 8170-2008 Rules of rounding off for numerical values & expression and judgement of limiting values
3 Requirements
The content of all carcinogenic dyes (see Annex A) in dye products shall not be more than 150 mg/kg.
4 Theory
After the sample is dissolved (or extracted), carry out qualitative determination through high-performance liquid chromatography-diode array detector (HPLC-DAD) method and quantitative determination for carcinogenic dyes through peak area external standard method; carry out qualitative determination for uncertain sample detected through liquid chromatography-tandem mass spectrometry (HPLC-MS).
5 Test methods
5.1 General requirements
Unless otherwise specified, only recognized analytically pure reagents and Grade-III water (specified in GB/T 6682-2008) shall be adopted. The inspection result shall be judged according to the rounding-off value comparison method specified in 4.3.3 of GB/T 8170-2008.
5.2 Reagents and materials
5.2.1 Standard carcinogenic dyes (see Annex A).
5.2.2 Methanol: chromatographically pure.
5.2.3 Acetonitrile, chromatographically pure.
5.2.4 n-tetrabutyl ammonium bromide.
5.2.5 Potassium dihydrogen phosphate.
5.2.6 Ammonium acetate.
5.3 Instruments and apparatus
GB/T 37040-2018 The following standards are cited：
