Sterility
Definition
The absence of viable microorganisms in a preparation. It is conferred by a process and preserved by a closure, so it is lost the moment either is compromised and nothing about the appearance of a vial reports that.
Terms used in this definition
Other entries this definition refers to.
Where this term comes up
Entries whose definition mentions Sterility.
What this means for research sourcing
Purity and identity verification are central to research reproducibility. Every Volta compound ships with >99% HPLC-verified purity and a certificate of analysis.
Related Terms in Quality
Assay
Any procedure that measures whether something is present, how much of it there is, or how active it is. Analytical assays report composition; functional assays report activity, and a material can pass one and fail the other.
Quality Control (QC)
The testing a batch passes through before release, typically identity by mass spectrometry, purity by HPLC, content and, where relevant, water, sterility and endotoxin. QC is the set of tests; the certificate is the report of their results.
Degradation Product
A compound formed as a peptide breaks down, through oxidation, deamidation, hydrolysis or aggregation. Certificates report these as impurity peaks, and their pattern says more about how a batch was handled than the headline purity figure does.
Reference Standard
A well-characterised sample run alongside an unknown so that retention time and response can be compared against something known. Without one, a chromatogram shows separation but supports no identification.
Batch Number
The identifier tying a quantity of material to the records of its manufacture and testing. It is the only thing linking a vial in hand to a certificate on a screen, which is why a certificate whose batch number does not appear on the label proves nothing about that vial.
Third-Party Testing
Analysis by a laboratory with no commercial interest in the result, as against in-house testing by the manufacturer or seller. The independence is the whole value, and it is only real if the laboratory is named and its report is reproducible.
X-Ray Crystallography
Determination of a molecule's three-dimensional atomic structure from the diffraction pattern of a crystal of it. It is a structural method rather than a release test, and it is how most receptor and ligand geometry in the literature was established.
cGMP (Current Good Manufacturing Practice)
The regulations governing how licensed pharmaceutical manufacturers must produce and control a product, covering facilities, records, personnel and validation. They apply to drug manufacture and not to research-grade supply, which is a distinction worth keeping straight.