[48] Analysis results of racemic ethyl 4-chloro-3-hydroxybutyrate are as follows: [49] 1 H-NMR (CDCl 3 ) = 1.28 (3H,t), 2.62 (2H,d), 3.53 (lH,br), [50] 3.60 (2H,d), 4.20 (2H,q), 4.33 (lH,m) [51] [52] Example 3: Preparation of ethyl (RV4-chloro-3-hvdroxybutyrate (4) [53] 40 g (10% w/v) of racemic ethyl 4-chloro-3-hydroxybutyrate was added to a flask containing 360 mL of 0.1M potassium phosphate buffer (pH 8.0) to which 4 g (1% w/ v) of immobilized lipase Novozyme 435 was then added, followed by reacting at 30 0 C
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In practice, that covers: HPLC (high-performance liquid chromatography) purity testing on the active peptide prior to fill Sterility and bioburden checks on the finished cartridge Lot-number assignment tying the analytical results to the specific production run Specific purity percentages and endotoxin limits for the current batch should be confirmed with our QC team at the point of order rather than assumed from a generic specification sheet
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