What documentation would apply to standards?
Full characterization information as stated at 40 CFR 160.105 is required of standards. This section requires that any information that is appropriate for defining the standard, including identity, strength, purity, or composition, shall be determined for each batch before it is used. In the case of an analytical standard, for example, it is necessary to obtain analysis data documenting the identity, strength, and purity, for each batch. A labeled assay value, in and of itself, is insufficient.
Have more questions? Submit a request