HPLC-UV purity
Answers: how much of the sample is the main compound?
Reversed-phase high-performance liquid chromatography separates the sample's components by hydrophobicity, and a UV detector records each as a peak. Purity is the main peak's area as a percentage of all detected peak area. GLP-3 RT elutes as a single sharp peak at about 14.4–14.9 minutes on current certificates.
Limits: does not identify the peak, and impurities that co-elute or absorb weakly in UV can be under-counted. More on HPLC
LC-MS identity
Answers: is the main compound GLP-3 RT?
The separated sample enters a mass spectrometer via electrospray ionization, which gives the molecule one or more charges. The observed ions, near m/z 1578 (3+) and 1184 (4+), are matched against values calculated from GLP-3 RT's molecular weight of 4731.33.
Limits: confirms molecular weight, not amino-acid order. More on mass spectrometry
Bacterial endotoxin (LAL)
Answers: is endotoxin below the assay threshold?
The Limulus amebocyte lysate assay, performed per USP <85>, detects lipopolysaccharide from Gram-negative bacteria. Where run, the method and result are printed on the lot record; lot KB89232: Pass (LAL assay per USP <85>, 2 replicates, sensitivity ≤0.05 EU/mL).
Limits: a pass means below the assay threshold for the sample tested. Reported per lot; the lot table shows which lots were tested.
Microbial DNA (PCR)
Answers: is DNA from common microbial contaminants present?
A polymerase chain reaction assay amplifies genetic material from common microbial contaminants so it can be detected. Where run, the result is reported as detected or not detected.
Limits: detects DNA from targeted organisms only. It is not a sterility test and does not distinguish live from dead organisms.
Net content
Answers: how much GLP-3 is in the vial?
The laboratory quantifies the main compound in the tested vial against a standard. It is reported in milligrams next to the labeled vial size.
Limits: measured on the vial tested; other vials from the same lot are expected to be similar but are not individually measured.