Key points
A narrow, evidence-based reading
- Read each term with the test method and sample it refers to.
- Identity, purity, amount, and stability have different meanings.
- A definition helps explain a record. It does not certify a material.
Documents and records
These terms help connect a research material to its records. Organizations may use words differently, so follow the procedure and documents that apply where you work.
- Certificate of analysis (COA)
- A report that lists tests, test methods, pass requirements, and results from the organization that issued it.
- Catalog code
- A supplier's code for a listing or container type.
- Chain of custody
- A written record of who had a material or sample, where it went, and who was responsible for it.
- Specification
- A list of tests and pass requirements used to check a material for a stated purpose.
Test results
Keep each result with the test method, units, sample, and pass requirement that produced it. Similar-looking numbers can come from very different tests.
- Identity
- Test evidence that a sample appears to be the named material.
- Purity
- A description of how much of a tested sample appears to be the main component under a stated test method.
- Assay or content
- A measurement of the amount of a named component in a sample.
- Pass requirement
- A number, range, or other condition used to judge a result.
- Pass or conforms
- A result that met the listed pass requirement. It says nothing about questions the test did not cover.
HPLC and LC-MS
Instrument names tell you the type of tool used. The written test method, settings, reference materials, controls, calculations, and validation tell you what the result can support.
- HPLC
- High-performance liquid chromatography. A liquid test that separates parts of a sample and records detector signals over time.
- LC-MS
- Liquid chromatography with mass spectrometry. It separates parts of a sample and measures ions by mass-to-charge ratio.
- Chromatogram
- A chart of detector signal over time from an HPLC test.
- Retention time
- The time when a signal appears during a specific HPLC test.
- Mass spectrum
- A chart of detected ions and their mass-to-charge ratios from a mass-spectrometry test.
- Reference standard
- A well-described material used for comparison or calibration in a test.
Material form and stability
These terms describe the material and the period supported by records under stated conditions. They do not give directions for personal use.
- Lyophilized
- Freeze-dried to remove water. The word alone does not show the material's makeup, sterility, or storage life.
- Storage condition
- The recorded environmental range and protections used to support the material's records.
- Temperature excursion
- A recorded time outside the stated temperature condition that needs review and a decision.
- Retest date
- The date after which a material should be tested again before it is used further under the applicable system.
- Expiry date
- The end of a period supported by records under stated conditions, set by the responsible organization.
Scope of this glossary
This glossary supports laboratory, analytical, and educational research records. It does not create a specification, validate a method, interpret a specific result, or certify a supplier, laboratory, or material.
No definition on this page provides medical, clinical, dosing, administration, preparation, or personal-use guidance. Beach Bio Research catalog items are for scientific and research use only.
Primary references
Source notes
These references provide analytical and documentation context. Citing them does not claim that Beach Bio Research catalog items are approved products or that the cited regulatory frameworks apply to a particular catalog item.
- Q2(R2) Validation of Analytical ProceduresU.S. Food and Drug Administration. General framework for analytical-procedure validation and performance characteristics.
- Q6A Specifications: Test Procedures and Acceptance CriteriaU.S. Food and Drug Administration. Discusses identification, test procedures, specifications, and acceptance criteria.
- Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical IngredientsU.S. Food and Drug Administration. Includes a detailed description of information commonly recorded on certificates of analysis.
- Mass Spectrometry Instrument LaboratoryNational Institute of Standards and Technology. Overview of liquid chromatography and mass-spectrometry capabilities for chemical analysis.