What is analytical testing?
Analytical testing is the laboratory measurement of a material's identity, purity, quantity and contaminants using defined, named methods.
The questions analytical testing answers
- Identity: is the material what it is supposed to be? For peptides, usually answered by LC-MS.
- Purity: how much of the detected material is the target compound? Usually answered by HPLC.
- Quantity: how much is present? Reported as net content.
- Contaminants: is bacterial endotoxin or microbial DNA present? Answered by LAL and PCR assays.
Why several methods are used together
No single method answers every question. HPLC can show a sample is homogeneous without saying what it is; mass spectrometry can confirm molecular weight without measuring purity. Using complementary methods closes those gaps. The U.S. FDA's adoption of the ICH Q2(R2) guideline describes how analytical methods are validated for characteristics such as specificity and precision.
Analytical testing of Tesamorelin
Every Tesamorelin lot is tested by ILS Laboratories, an independent laboratory, for HPLC-UV purity, HPLC-RTM identity and net content, with endotoxin and PCR results where listed. Every test on every lot is listed in the Tesamorelin testing records.