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It should include: Batch number and lot code Testing methods (HPLC, mass spec, LAL endotoxin) Numeric results and acceptance criteria Analysts signature and date Look for at least 98% purity for clinical use

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Compounded sterile preparations carry a documented risk of contamination-related infection when pharmacy sterility standards are not maintained

doi: 10.1111/j.1479-828X.2007.00723.x 219 XuYNisenblatVLuCLiRQiaoJZhenXet al