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Bulk Drug Substances Nominated for Use in Compounding Under Section 503A Category 2 removal of BPC-157, April 22, 2026
doses per vial so you can measure accurately with standard insulin syringes
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and NLT 5.0 between the glutathione and l -phenylalanine peaks Relative standard deviation: NMT 1.5% for replicate injections Analysis Samples: Standard solution and Sample solution Calculate the percentage of any impurity in the portion of Glutathione taken: Result = (r U /r S ) (C S /C U ) 100 r U = = peak response of any peak from the Sample solution other than glutathione r S = = peak response of the glutathione peak from the Standard solution C S = = concentration of USP Glutathione RS in the Standard solution (mg/mL) C U = = concentration of Glutathione in the Sample solution (mg/mL) Acceptance criteria Individual impurity: NMT 1.5% for the impurity with the relative retention time of about 4 Total impurities: NMT 2.0% SPECIFIC TESTS Clarity and Color of Solution Sample solution: 0.1 g/mL in water Analysis: Using identical tubes of colorless, transparent, neutral glass with a flat base and an internal diameter of 1525 mm, compare the liquid to be examined with water, the depth of the layer being 40 mm
