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)
Members of our Laboratory Outsourcing Network can use our online platform to communicate with the Lab Requestor, submit responses with quotes and have access to more information such as budget, location required, etc.
Contract Laboratory can help you with all your Pharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:
Need Pharmaceuticals Testing or Scientific Research?
Save time and money searching. Simply, submit a Pharmaceuticals request to find the laboratories or lab suppliers that best meet your needs.
Life Sciences Company needs Laboratory for flash point and melting point testing of a 100-fold dilute solution of pyrrol... view
Pharmaceutical Analytical Laboratory needed for Gel Strength (Bloom Value) in Gelatin NF testting view