Quality Control & Testing
Review the available batch-specific analytical documentation before selecting material for a laboratory protocol.
Batch-Specific Documentation
Certificates of Analysis report the tests and results available for a specific batch. Methods and reported specifications can vary, so researchers should review the document associated with the material they order.
HPLC Analysis
High-Performance Liquid Chromatography can separate components in a sample and report relative peak-area purity. Refer to the batch COA for the method and result actually reported.
Mass Spectrometry
Mass spectrometry can compare an observed molecular mass with the expected mass. Refer to the batch COA to see whether this analysis was performed and what result was reported.
Amino Acid Analysis
When provided, sequence or amino-acid analysis offers additional identity information. Its presence and scope should be confirmed on the applicable batch document.
Endotoxin Testing
Endotoxin testing, when listed on a batch COA, reports the result for the tested sample and method. It should not be inferred from a purity result alone.
Method Scope
Chemical identity and purity tests do not establish sterility, endotoxin status, biological activity, or suitability for a particular protocol unless those endpoints are separately tested and reported.
Document Review
Researchers should compare the batch identifier, test date, reported method, result, and specification shown on each document and retain it with their laboratory records.
Certificate of Analysis (COA)
Available batch documents may include:
- HPLC chromatograms and reported relative purity
- Mass spectrometry data and observed molecular mass
- Additional identity or composition results, when performed
- Endotoxin or other assay results, when separately performed
- Batch number and manufacturing date
- Documented storage information and applicable dates
Before Beginning a Study
Confirm that the batch identifier on the material matches its documentation and determine whether the reported methods and specifications are appropriate for the planned nonclinical laboratory work.
A COA describes the submitted sample and reported tests; it does not establish clinical safety, effectiveness, regulatory approval, or suitability for human or veterinary use.