Samples: All samples generated for non-GLP studies including cell matrices, animal plasma, whole blood, brain, liver, muscle, ophthalmic tissues and more.

Typical studies: Pharmacokinetic (PK) studies in preclinical species (rodent, canine and primates) by oral, IV, or subcutaneous doses. -Cassette dose studies for PK screening -Exploratory safety or toxicology studies -Tissue distribution studies

Analytical Procedure: Protein precipitation is the default sample extraction method. Tissue samples are homogenized in appropriate solutions first. The supernatant is analyzed using LC-MS/MS. Liquid-liquid or solid phase extraction will be explored only when the generic approach fail to meet your standard. Each compound is optimized for its MS/MS parameters. Cross talking is checked if multiple compounds are analyzed simultaneously. Based on the chemical and physical properties of the compounds, methods of reversed phase chromatography or hydrophilic interaction chromatography are tested quickly to achieve acceptable retention time and peak shape. An analog internal standard (IS) will be selected if available. Otherwise, a generic IS is used. Ion suppression caused by matrix effect or any other concerns from customers will be evaluated and explained.

Quality control: Minimum one standard curve (> 6 points), and four sets of quality control samples with levels spreading the calibration range will be used in each run. Linear regression with 1/x or 1/X2 weighing is generally used. Precision (%RSD) and accuracy summarized from QCs have to be less than 20% and within ±25% of nominal values, respectively. Any specific requirements from customers can be discussed.

Data reporting: Concentrations will be reported in excel tables or any electronic format specified by customers. PK parameters, plasma/tissue ratios can be calculated and reported per your requests.