Sample and document terms

TermMeaning and example
Batch / lotA defined group linked to records. The full lot connects supplied material to its test record; a product name alone does not.
Laboratory sample IDThe lab’s own identifier. It may differ from the vial lot, so a recorded connection is needed.
COACertificate of Analysis: findings for an identified submitted sample, not a universal certificate for a brand.
SpecificationThe requirement used to assess a result. “NLT 98%” is a threshold, not a measured 98% result.
RevisionA changed version of a report. Use the current issued version and retain the record of the change.

Composition and amount

TermMeaning and example
PurityRelative composition on the stated analytical basis. Peak-area purity is not automatically a mass percentage.
IdentityEvidence that material matches the intended compound. High purity alone cannot prove the right compound.
QuantityMeasured amount, such as mg/vial. A 9 mg result is not changed by a separate 99% purity figure.
Peptide contentA method-defined content value. Counterions and moisture can make gross powder mass differ from peptide mass.
ConcentrationAmount per volume, such as mg/mL. It needs the relevant preparation volume.
Blend ratioThe relative amounts of components. A total alone cannot establish each amount.

Methods and signals

TermMeaning and example
ChromatogramDetector signal over separation time. One visible peak can include overlapping components.
HPLCHigh-performance liquid chromatography; separates components under specified conditions.
LC-MSLiquid chromatography plus mass spectrometry; adds mass-to-charge evidence.
m/zMass-to-charge ratio. Multiple charges mean a peak need not equal the neutral molecular mass.
ICP-MSElemental analysis for named targets; not a peptide identity test.
CalibrationRelating instrument response to references so a measurement can be interpreted quantitatively.

Limits and result wording

TermMeaning and example
LODLimit of detection: the procedure’s detection capability under defined conditions.
LOQLimit of quantitation: the lower boundary for adequately reliable numerical measurement under the method.
NDNot detected. It does not mean absolute zero or cover unnamed targets.
NMT / NLTNot more than / not less than the stated requirement.
PendingA final finding is not yet available; it is not a pass.
UncertaintyEvaluated dispersion associated with a measurement. It is not permission to pick the most favorable value.
Accuracy / precisionAgreement with a reference / consistency of repeated measurements. These differ.

Microbiology and records

TermMeaning and example
EUEndotoxin units: activity, not the number of bacteria.
CFUColony-forming units: recovered growth, not necessarily individual cells.
BioburdenMicrobial burden assessed by a defined method. Low counts do not establish sterility.
Method suitabilityEvidence that the procedure can work in the sample’s presence, including relevant interference or recovery checks.
Batch traceabilityThe vial-to-batch-to-report record connection.
Measurement traceabilityA documented calibration connection to a reference; different from a lot-number match.

Sources

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