The vocabulary of laboratory testing, explained plainly. Every term first in two sentences, then in depth.
93 terms
An accreditation scope is the official, itemized list of the tests, materials, and methods a laboratory has been independently assessed and confirmed as competent to perform. It shows which items on a lab report have accredited backing and which do not.
Full definition → GeneralAn active substance, also called an Active Pharmaceutical Ingredient (API), is the chemical molecule in a drug or research chemical that is intended to produce a biological effect. Laboratory testing checks its identity, purity, and exact content.
Full definition → GeneralAn anabolic-androgenic steroid (AAS) is a natural or synthetic hormone derived from testosterone that promotes tissue-building and male characteristics. In lab testing, products are screened for anabolic-androgenic steroids to detect accidental contamination or mislabeling with these drugs.
Full definition → AnalysisAnalytical method validation is the formal, documented proof that a laboratory test reliably does what it is intended to do, such as measuring a substance's purity, identity, or safety. Without this validation, the numbers on a lab report remain unverified, and their accuracy is unknown.
Full definition → AnalysisAAS (Atomic Absorption Spectroscopy) is a laboratory technique used to measure the concentration of specific metal elements in a sample. In peptide testing, AAS screens for toxic heavy metals to help assess safety. It does not verify a peptide's identity or purity.
Full definition → MethodBioburden is the amount and type of living microorganisms, such as bacteria or fungi, present in a sample before sterilization. It is used as a measure of the microbial cleanliness of a product's manufacturing process.
Full definition → RegulationBiologics are large, complex medicines made from living organisms. Examples include vaccines, blood components, gene therapies, and recombinant proteins. They are different from chemically synthesized drugs.
Full definition → GeneralBlind testing is a quality-control practice in which samples with known composition are sent to a laboratory without analysts being told what they are. The laboratory handles them like ordinary specimens, and the results are compared with the true values.
Full definition → AnalysisBotanical identification is a binary laboratory test that checks whether a plant-derived material matches the claimed plant species and plant part. It answers "Is this the same as the target material?" rather than the open-ended question "What is this material?"
Full definition → AnalysisCE-SDS is an automated laboratory technique that separates large proteins and peptides by size to assess their purity. It measures how much of a sample is the correct intact molecule and how much consists of broken fragments or aggregates.
Full definition → GeneralChain of custody is the documented record of how a laboratory sample is handled, where it is stored, and who handled it, from collection to final testing. It helps prove that the tested material was not altered, contaminated, or swapped.
Full definition → AnalysisChromatography is a laboratory technique that separates a complex mixture into its individual components. It helps scientists measure a sample's purity and assess its impurities.
Full definition → AnalysisCD means Circular Dichroism, a laboratory technique that measures how chiral ("handed") molecules absorb polarized light. The result helps show their 3D folded shape in solution. CD is a structural test; it does not test purity or molecular weight.
Full definition → AnalysisCLND means Chemiluminescent Nitrogen Detection. It is a lab method used to measure the exact amount of nitrogen in a sample. CLND helps determine the purity and concentration of nitrogen-containing compounds, such as peptides, even when a perfect reference standard is not available.
Full definition → AnalysisA Certificate of Analysis (COA) is a formal laboratory document that reports measured test results for a specific batch of a product. It provides measured data used to prove the item's identity, purity, and quality.
Full definition → RegulationA competent authority is a government regulator with legal authority over medicines and clinical trials. It can authorize, inspect, enforce standards, and set rules for testing labs and manufacturers, but it is separate from analytical testing and does not issue Certificates of Analysis.
Full definition → GeneralA contract laboratory is an independent third-party testing facility hired to check products for identity, purity, and safety. Unlike an in-house lab owned by the seller, it can generate data for a Certificate of Analysis (CoA).
Full definition → GeneralA contract manufacturer is a company that makes a product for the company that owns the brand. This work can include synthesis, purification, and packaging. It is covered by a formal Quality Agreement that assigns responsibilities under Good Manufacturing Practice.
Full definition → GeneralA contract research organization (CRO) is an independent, third-party laboratory hired to perform specialized testing and research services. In lab testing, a CRO objectively measures a sample's purity, identity, and safety to provide an unbiased Certificate of Analysis (COA).
Full definition → MethodCytotoxicity testing checks in the lab whether a substance harms or kills living cells in culture. A pass only rules out acute cell damage under those test conditions, not product safety, purity, sterility, or identity.
Full definition → AnalysisDifferential Scanning Calorimetry (DSC) is a test method that measures how a sample reacts to heat compared with a reference material. For peptides, DSC is used to assess thermal stability and structural changes, including melting or unfolding.
Full definition → GeneralDrug checking is a harm-reduction service that chemically analyzes a physical substance sample to confirm its exact identity, purity, and potency, and detect dangerous adulterants. It lets individuals anonymously submit unregulated-market samples so they can see exactly what those samples contain.
Full definition → AnalysisDLS (dynamic light scattering) is a laboratory technique used to measure the physical size of particles suspended in a liquid. It is mainly used to detect unwanted clumps of molecules, called aggregates. DLS does not identify a substance chemically and does not prove its purity.
Full definition → GeneralEndotoxins are toxic fragments released from the outer membrane of Gram-negative bacteria. If injected, they can cause severe fever and inflammation. A laboratory test measures endotoxin concentration to ensure injectable substances are safe for human use.
Full definition → RegulationFDA Establishment Registration is a mandatory FDA facility registration in which a facility provides its name, address, and activity information to the FDA. It does not measure, verify, or certify the purity, identity, or safety of any product, and it is not FDA approval.
Full definition → AnalysisForensic analytics is the use of rigorous, documented analytical chemistry methods to verify a substance's identity, purity, and other contents. In peptide testing, forensic analytics refers to laboratory work that applies forensic-grade rigor when checking identity, purity, and impurity profiles.
Full definition → AnalysisGC-MS (gas chromatography-mass spectrometry) is a two-stage analytical technique that separates volatile, heat-stable chemicals, then identifies them by molecular mass and fragment pattern. It suits small volatile molecules, but not intact peptides, because heat typically destroys peptides before measurement.
Full definition → AnalysisGlycomics is the comprehensive study of complex sugar molecules, called glycans, that are produced by a cell or organism. In laboratory testing, glycomics profiles sugar attachments on biologic drugs to verify their identity, purity, and safety.
Full definition → AnalysisGlycoproteomics is a testing method that identifies which sugar molecules are attached to specific proteins and where they are located. This information is used mainly to check the safety and function of biological therapeutics, including monoclonal antibodies.
Full definition → RegulationGood Laboratory Practice (GLP) is a strict regulatory quality system for ensuring the validity and integrity of non-clinical safety studies, including animal toxicity tests. GLP does not apply to routine chemical purity testing of a single batch.
Full definition → RegulationGood Manufacturing Practice (GMP) is a legally enforceable quality system that ensures drugs, active pharmaceutical ingredients, and peptides are manufactured and tested consistently according to strict safety and quality standards.
Full definition → RegulationHACCP (Hazard Analysis and Critical Control Points) is a preventive food-safety management system. It is not a laboratory test. HACCP identifies and controls biological, chemical, and physical hazards during food production; it does not measure the purity or identity of a peptide or research chemical.
Full definition → GeneralHarm reduction is a public-health approach that uses chemical analysis to identify the actual contents, purity, and potential adulterants of unregulated substances. It helps individuals make informed decisions to minimize health risks.
Full definition → AnalysisHeavy metal is an outdated term for potentially toxic metallic elements, including lead, arsenic, cadmium, and mercury, that can contaminate a product during manufacturing. Modern lab testing uses the more precise term "elemental impurities."
Full definition → AnalysisHost cell proteins are unwanted proteins that remain from the cells used to manufacture biologic drugs. They are considered impurities and must be removed because they can trigger immune reactions or affect the drug's stability.
Full definition → AnalysisHPLC (High-Performance Liquid Chromatography) is a laboratory method used to separate, identify, and measure the individual components of a liquid mixture. It is the main method for testing the purity of peptides and research chemicals.
Full definition → RegulationICH guidelines are globally harmonized scientific rules for validating analytical laboratory tests. They set a common standard for how laboratories confirm that tests for identity, purity, and safety are accurate, reliable, and reproducible.
Full definition → AnalysisicIEF (imaged capillary isoelectric focusing) is a laboratory technique for separating and analyzing proteins and peptides by their electrical charge. The charge fingerprint is used to check the identity, purity, and batch-to-batch consistency of biopharmaceutical samples.
Full definition → AnalysisICP-MS (Inductively Coupled Plasma Mass Spectrometry) is a highly sensitive laboratory test for detecting and measuring chemical elements, including heavy metals, in extremely small amounts. The method destroys the sample completely. It can demonstrate metal safety, but it cannot identify the molecule itself.
Full definition → AnalysisICP-OES is a laboratory technique for detecting and measuring trace amounts of elemental impurities, such as heavy metals, in a sample. It can support checks for toxic metal contamination in products, but it cannot identify the actual molecular structure of a substance.
Full definition → AnalysisIon chromatography is a laboratory technique used to separate and measure electrically charged molecules. In peptide testing, it measures the weight of acidic salts, such as TFA, attached to the powder. This helps estimate the true amount of active peptide.
Full definition → MethodISO 10993-5 is an international standard for laboratory testing of whether a material kills or damages mammalian cells grown in a dish. It was developed for medical devices and does not test chemical purity or chemical identity.
Full definition → RegulationISO 22716 is an international standard that sets out Good Manufacturing Practice (GMP) guidelines for the cosmetics industry. It describes how a manufacturing facility should be organized and controlled; it is not a specific laboratory test.
Full definition → AccreditationISO 9001 is an internationally recognized standard for a quality management system (QMS). For a laboratory, it shows that administrative processes are organized, but it does not confirm the technical accuracy or validity of specific test results.
Full definition → AccreditationISO/IEC 17020 is an international standard that certifies the competence and impartiality of inspection bodies, meaning organizations that examine products or processes and issue a pass/fail judgment. It is not the appropriate standard for analytical laboratory reports, including reports that test chemical purity.
Full definition → AccreditationISO/IEC 17025 is the main international standard for assessing whether testing laboratories are technically competent and reliable. When a lab is accredited to ISO/IEC 17025, an independent body has audited its methods, staff, and equipment to check that the lab can produce valid results.
Full definition → AnalysisKarl Fischer titration is a laboratory method for accurately measuring water in a sample. For peptides, this matters because excess moisture can cause degradation, while unaccounted water can make a product's apparent purity look higher than it is.
Full definition → AnalysisA label claim is the manufacturer's statement on a product label about the product's identity, concentration, or quantity. Laboratories use the label claim as a benchmark when they compare it with the product's actual measured results in testing and reporting.
Full definition → AnalysisLC-MS (Liquid Chromatography-Mass Spectrometry) is a two-step laboratory test. First, it separates a mixture into its individual parts; then, it identifies those parts by measuring their exact molecular mass. It is considered the gold standard for verifying a substance's identity and purity.
Full definition → AnalysisLeachables and extractables are chemical impurities from packaging or manufacturing equipment that can migrate into a final product. Extractables are chemicals that could migrate under harsh laboratory conditions, while leachables are chemicals that actually migrate into the product during normal storage and use.
Full definition → GeneralA Laboratory Information Management System (LIMS) is a laboratory software platform for tracking samples and managing laboratory workflows and data. It does not carry out physical or chemical measurements. Instead, a LIMS organizes and secures the data produced by analytical instruments.
Full definition → MethodLAL (Limulus Amebocyte Lysate) is a laboratory test that detects bacterial endotoxins, which are fever-inducing fragments of dead bacteria, in pharmaceuticals and research chemicals. By detecting these endotoxins, LAL helps confirm that a product is free from biological contamination that could cause severe immune reactions.
Full definition → AnalysisMass spectrometry (MS) is an analytical technique that identifies a molecule by measuring its mass-to-charge ratio. In peptide and research-chemical testing, it confirms identity - in other words, it answers "what is this molecule?" - rather than purity.
Full definition → GeneralA microbial contaminant is an unwanted living microorganism, such as bacteria, yeast, or mold, that gets into a product during manufacturing or handling. These biological impurities pose serious safety risks and are measured separately from a product's chemical purity.
Full definition → MethodMicrobiological testing is a category of laboratory tests used to detect, count, or identify living microorganisms and their toxic byproducts in a sample. It checks biological safety and contamination levels separately from chemical purity.
Full definition → AnalysisMobile spectrometry means compact, portable mass spectrometry devices used for on-site, real-time chemical analysis outside a traditional laboratory. It refers to a category of devices, not to one standardized test.
Full definition → AnalysisMRM (Multiple Reaction Monitoring) is a targeted mass spectrometry method that verifies whether a specific known molecule is present in a sample and measures how much of it is there, using two rounds of mass filtering for high specificity.
Full definition → AnalysisNMR (nuclear magnetic resonance) is an advanced analytical technique that uses strong magnetic fields and radio waves to create a molecule's structural fingerprint. It can verify exact chemical identity and absolute purity without chemical separation beforehand.
Full definition → RegulationA "nutraceutical" is a marketing term that combines "nutrition" and "pharmaceutical." It describes a food or food product that claims to offer medical or health benefits. It is not a laboratory measurement and has no formal regulatory definition.
Full definition → AnalysisOOS stands for Out-of-Specification. It refers to a laboratory test result that is outside the officially established acceptable limits for a product's purity, identity, or quality.
Full definition → GeneralA peptide is a short chain of 2 to 50 amino acids that are linked together. In laboratory testing, a peptide is analyzed to confirm its purity and identity.
Full definition → AnalysisPeptide analysis is a combined set of laboratory chemistry methods that checks a peptide sample's identity, purity, actual peptide amount, and impurities.
Full definition → AnalysisPeptide content is the percentage of a sample's total weight that is actual peptide, rather than non-peptide material such as water, salts, and residual solvents.
Full definition → AnalysisPeptide purity is a laboratory value that shows the percentage of the target peptide in a sample compared with peptide-related impurities, such as truncated or incomplete sequences. It does not include non-peptidic contaminants, such as water or salts.
Full definition → AnalysisPeptide quantitation is a laboratory test that measures the exact amount of a specific peptide in a sample, vial, or solution. It answers a direct question: how much peptide is present?
Full definition → AnalysisPesticide residue testing is a laboratory process used to detect, identify, and measure trace amounts of agricultural pest-control chemicals that remain on food and feed products. It checks whether those residues are within legal safety limits.
Full definition → AnalysisPharmaceutical analysis is a scientific laboratory discipline that uses validated methods to check a substance's identity, measure how much active ingredient is present, and determine whether impurities exist.
Full definition → AnalysisA presumptive test is a quick screening method that can suggest a substance may be present or belong to a broad chemical class. It does not prove identity, purity, or safety; any positive result needs confirmation by a more specific instrumental method before reliable assessment.
Full definition → RegulationProcess validation is documented scientific proof that a manufacturing process can consistently and reproducibly produce a product that meets its specifications for purity, identity, and quality - not just once, but every time.
Full definition → AnalysisA process-related impurity is an unwanted substance in a final product that comes directly from manufacturing, such as leftover reagents or incorrectly assembled peptide chains. It is different from a substance formed when the product breaks down over time.
Full definition → AnalysisProtein characterization is a set of laboratory tests that confirms a protein or peptide sample’s identity, purity, quantity, and structure. It confirms that the correct molecule is present at the expected amount and that the sample does not contain hidden impurities.
Full definition → AnalysisProteomics is the large-scale study and analysis of all proteins in a sample. In a laboratory, it typically uses mass spectrometry to identify, quantify, and analyze these proteins.
Full definition → AnalysisA qualification protocol is a formal set of tests that confirms a piece of laboratory equipment is installed correctly and functions accurately. It helps ensure that the equipment used to test a sample is reliable before any results are generated.
Full definition → AnalysisQualitative analysis is a laboratory test that identifies what is present in a sample. It checks whether the correct peptide or chemical is there, rather than measuring how much of it is present.
Full definition → GeneralQuality control (QC) is the laboratory testing of a finished product batch to verify its identity, purity, and safety before release. It is a final inspection step that uses scientific testing methods to detect defects.
Full definition → AnalysisRadiopharmaceutical analysis is the strict laboratory quality-control testing of medicines that contain radioactive isotopes. Its purpose is to check, before these radioactive drugs are given to a patient, that they are safe, effective, and chemically correct.
Full definition → RegulationA regulatory submission is a formal package of documents and scientific data that a manufacturer sends to a health authority, such as the FDA or EMA, to show that a drug is safe, effective, and of consistent quality before it can be marketed.
Full definition → RegulationRelease testing is the final mandatory laboratory testing carried out on a manufactured batch. It confirms the batch's identity, purity, and safety before the batch can be distributed or sold.
Full definition → GeneralA research chemical is a laboratory quality-grade label for a substance intended only for bench use, not human or veterinary use. In illicit-drug contexts, the same term is slang for novel psychoactive substances such as “designer drugs” or “legal highs”; that is a separate meaning.
Full definition → Regulation"Research Use Only" (RUO) is a regulatory label for a laboratory product or chemical that may be used only for laboratory research. It means the product or chemical has not been approved or validated by the FDA for clinical, diagnostic, or human use.
Full definition → AnalysisResidual solvents are small traces of volatile manufacturing chemicals that remain in a product after production and purification. Laboratories test for residual solvents to check whether the final product is safe and meets regulatory limits.
Full definition → GeneralSample traceability is the documented ability to follow a laboratory sample's complete history, from collection and labeling through storage, analysis, and disposal, so that test results can be clearly linked to the specific batch tested.
Full definition → GeneralSARM stands for Selective Androgen Receptor Modulator, a synthetic, experimental class of drugs that mimic testosterone's muscle- and bone-building effects. In laboratory testing, a SARM is a substance that labs screen for. It is not a test method itself.
Full definition → GeneralSERM stands for Selective Estrogen Receptor Modulator. It refers to a class of drugs that act on estrogen receptors in the body. SERM is not a laboratory test or an analytical method.
Full definition → MethodSolid-phase peptide synthesis (SPPS) is a laboratory method for producing peptide chains step by step on solid resin beads. It is not a test; it is the production process, while later lab reports analyze its outputs for purity and identity.
Full definition → AnalysisSolubility testing measures how much of a substance, such as a peptide, dissolves in a specific liquid. Researchers use it to determine suitable solvents for sample preparation. It does not prove a substance's purity or identity.
Full definition → AnalysisSpectroscopy is a category of laboratory tests that measures how a sample interacts with energy, such as light or radio waves, to determine its structural identity. It produces a unique molecular "fingerprint" that shows what a substance is at the atomic level.
Full definition → GeneralA Standard Operating Procedure (SOP) is an authorized, written set of instructions for specific laboratory operations. It ensures that tests are carried out consistently and safely, so the results can be trusted and verified.
Full definition → MethodSterility testing is a laboratory pass/fail test that checks whether a sample contains live, reproducing microorganisms, such as bacteria or fungi. The result helps support product safety by showing whether the sample passes or fails this check.
Full definition → MethodTAMC (Total Aerobic Microbial Count) is a laboratory test that measures the total number of living, oxygen-dependent bacteria and fungi in a sample. The result helps assess whether a product is microbiologically safe.
Full definition → AnalysisTYMC (Total Yeast and Mould Count) is a microbiological test that measures the number of living fungi, specifically yeasts and moulds, in each gram or millilitre of a non-sterile product. The result is reported as colony-forming units (CFU/g or CFU/mL).
Full definition → RegulationUSP means United States Pharmacopeia, a nonprofit scientific organization with legally recognized quality standards for medicines and their ingredients. In a lab report, a USP reference can mean a testing method, reference standard, chemical grade, or official specification, depending on context.
Full definition → RegulationWHO prequalification is a voluntary assessment program run by the World Health Organization. It evaluates medicines, pharmaceutical ingredients, and testing laboratories to check whether they meet international standards for quality, safety, and efficacy.
Full definition →No matching term.
