Component analysis is one of the core contents of COA, which directly affects whether the product complies with relevant US regulations (such as FDA, USP, ASTM, etc.) and market access requirements.

美国 COA 中成分分析的核心内容

美国 COA 的成分分析需基于严谨的检测数据，通常包含以下关键信息：


  1. 产品基本信息
    包括产品名称、批号（Lot Number）、生产日期、检测日期、规格型号等，确保成分分析与具体批次产品一一对应。
  2. 成分列表及含量

    • 主要成分：明确产品中起核心作用的成分名称（通常用化学名称或 INCI 名称，如食品中的 “维生素 C”、药品中的 “布洛芬”）及含量（如质量百分比、浓度等）。

    • Accessories/additives: such as preservatives in food, emulsifiers in cosmetics, etc., must be labeled with their names and compliant content (in accordance with the limit requirements of FDA and other agencies).

    • Impurities/residues: such as heavy metal residues, organic solvent residues in drugs, pesticide residues/animal residues in food, etc., it is necessary to clarify the detection values and whether they meet the limit standards (such as USP's heavy metal limit<10ppm).

  4. Chromatography methods: HPLC (high-performance liquid chromatography, used for component quantification), GC (gas chromatography, used for volatile component analysis);

  5. Spectroscopy: UV Vis (ultraviolet visible spectroscopy), IR (infrared spectroscopy, used for component characterization);

    ;

  6. Titration method (such as acid-base titration, complexometric titration, used for quantification of constant components);

    ;

  7. Other: such as atomic absorption spectroscopy (AAS) commonly used for heavy metal detection.

  • Targeted: The focus of ingredient analysis varies across different industries (such as drugs requiring testing for active ingredient content and stability, cosmetics requiring testing for prohibited ingredients), and testing items need to be matched according to product categories.

  • Timeliness: The composition analysis results of COA are only valid for specific batches and must be within the validity period of the test reportInternal use (usually associated with product shelf life).