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Meets Requirements vs. Meets Chemical Requirements

Information 

Question Regarding the Certificate of Analysis (CoA), what is the difference between Meets Requirements and Meets Chemical Specifications?
Answer

·       Meets Requirements – This indicates that the product complies with the official public standards. This includes, but is not limited to chemical specifications, physical properties (e.g., viscosity, density, particle size), performance standards (e.g., stability, reactivity), regulatory compliance (e.g., FDA, REACH), packaging, labeling, safety and handling.

 

·       Meets Chemical Specifications – This is a subset of Meets Requirements. A product may meet chemical specifications while not meeting the broader requirements due to the ways in which a given material is applied. Meets Chemical Specifications indicates that the product meets the established chemical acceptance criteria such as purity levels, concentration of active ingredients, presence or absence of certain impurities, pH, solubility, or other chemical properties.

 

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File Meets Requirements and Meets Chemical Specifications R.0.pdf
Keyword Meets Requirements, Meets Chemical Specifications, Compendial Requirements
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