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Pharmaceutical USP Impurity Testing
Large Pharmaceutical Company needs Analytical Chemistry Laboratory for USP Impurity Testing: . Limit of xxxxx-isomer and other Impurities (by HPCE): Current USP-NF
Buffer: 19.1 g/L of sodium borate decahydrate in water. Adjust with phosphoric acid to a
pH of 2.2.
Run buffer: 50 mg/mL of hydroxypropylcyclodextrin in Buffer
Diluent: 0.02 M hydrochloric acid
Internal standard solution: 0.2 mg/mL of tryptamine hydrochloride in Diluent
System suitability solution: 0.01 mg/mL of tryptamine hydrochloride from the Internal standard solution, 1 mg/mL of USP xxxxx RS, and 0.01 mg/mL each of USP xxxxx Related Compound F RS, USP xxxx Related Compound G RS, and USP xxxx R-Isomer RS, in Diluent
Standard solution: 0.01 mg/mL of tryptamine hydrochloride from Internal standard solution and 0.001 mg/mL of USP xxx RS in Diluent
Sample solution: 0.01 mg/mL of tryptamine hydrochloride from Internal standard solution and 1 mg/mL of xxx in Diluent. Filter the solution and protect from light.
Detector: UV 200 nm
Column: 75-µm × 50-cm uncoated fused-silica
Applied voltage: 15 kV
Run time: 1.5 times the migration time of xxxx
Samples: System suitability solution and Standard solution
[Note-See Table 1 for relative migration times.]
Resolution: NLT 1.5 between xxxx and xxx R-isomer peaks, System suitability solution
Relative standard deviation: NMT 5% for the peak response ratio of xxxx and tryptamine peaks, Standard solution
Samples: Standard solution and Sample solution
Calculate the corrected peak responses:
Result = (r/m)
r = peak response
m = migration time of the peak (min)
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