The VIP10 Analytical Evidence Decision Tree

Overview

Answer up front: match your specific question about a sample—identity, quantity, contaminants, representativeness, authenticity, authorization, or suitability for research—to the right report field or official source listed below; follow the linked decision branch and then read the indicated section or document for the evidence type it provides. Every branch ends by stating what remains unresolved for that sample, method, matrix, and date. Keep in mind: no single result proves sterility, safety, efficacy, Canadian authorization, chain of custody, or batch-wide uniformity.

How to use this decision tree: start with your question, pick the branch below, and consult the recommended report field or source. The guidance is intentionally procedural—focuses on where answers are found and what they can and cannot establish for your specific sample and test conditions.

H2: Is the substance present and chemically what it’s claimed to be? (Identity)

H2: How much of the compound is present? (Quantity / Assay)

H2: Are there unwanted chemicals, heavy metals, or microbial contaminants? (Contaminants)

H2: Was the sample collected and reported in a way that represents a lot or population? (Representativeness & Sampling)

H2: Is the product authentic or consistent with claimed origin/contents? (Authenticity & Adulteration)

H2: Is the product authorized for sale or registered in Canada? (Authorization & Regulatory Status)

H2: Is this sample suitable for research use or further study? (Research suitability)

Quick evidence-type summary table (what each source principally provides) | Question type | Primary report field or source | |---|---| | Identity | Lab identity data; VIP10 editorial guidance | | Quantity | Quantitative result + uncertainty; EURACHEM on uncertainty , VIP10 | | Contaminants | Contaminant-specific sections in report; VIP10 | | Representativeness | Sampling description + EURACHEM sampling guide | | Authenticity | Multi-parameter analytical profile; VIP10 | | Authorization | Health Canada Drug Product Database | | Research suitability | Methods, purity, stability fields; VIP10 |

Final practical cautions

• Where to look: analytical identity sections in a laboratory report (e.g., mass spectra, retention times, assay identification criteria) or the VIP10 editorial reference for how identity claims are documented .
• What that evidence usually shows: instrument responses, matching reference spectra, chromatographic behaviour and described identification criteria. VIP10 explains editorial standards for reporting identity and what to expect in a transparent report .
• How to read it: verify that the laboratory lists the methods used to establish identity, the acceptance criteria, and any reference materials or spectral libraries cited. Confirm sample details (matrix, extraction) and date of analysis.
• Unresolved limits: identity evidence is sample-, method-, matrix-, and date-specific. A positive identification in one sample does not prove every unit in a lot contains the same substance; it does not prove purity, sterility, safety, or authorization. If the report uses library matches, the match score alone does not eliminate isomeric or closely related compounds without orthogonal confirmation.
• Where to look: quantitative result fields (concentration, mass per unit, percent w/w) and method validation data in the lab report; consult VIP10 for editorial expectations about reporting limits, uncertainty, and units ; consult analytical uncertainty guidance for interpretation .
• What that evidence usually shows: measured concentration, units, reported measurement uncertainty or confidence interval, limit of detection/quantification, and sometimes method calibration details.
• How to read it: check whether the report includes a stated uncertainty, the calibration range, and whether results are above the stated LOQ. EURACHEM guidance describes how sampling and measurement uncertainty components should be considered together .
• Unresolved limits: a single quantitative result is tied to the sample, method, matrix, and date. It does not prove lot-wide uniformity or ongoing concentration after different storage conditions. Measurement uncertainty and sampling uncertainty together may materially affect interpretation; if uncertainty is large relative to the claimed concentration, the quantitative claim remains provisional.
• Where to look: contaminant-specific sections of the lab report (e.g., heavy metals, solvents, pesticides, microbial screens) and the VIP10 editorial reference for what contaminant reporting should include .
• What that evidence usually shows: presence/absence, concentrations, or colony counts depending on analyte; method detection limits; any confirmatory testing performed.
• How to read it: confirm which analytes were tested (a negative result only covers analytes listed), the detection limits, and whether confirmatory methods were used. Consider analytical matrix effects and whether the sample preparation could mask certain contaminants.
• Unresolved limits: absence of tested contaminants does not prove the sample is free of all contaminants. Microbial screening results are specific to the sample tested and the methods used; no result proves sterility. Laboratory results do not by themselves establish product safety or efficacy.
• Where to look: sampling description in the report, chain-of-custody documentation, and EURACHEM guidance on sampling uncertainty ; VIP10 editorial notes on sampling expectations .
• What that evidence usually shows: who collected the sample, how many units were sampled, sampling method, heterogeneity considerations, and any estimate of sampling uncertainty.
• How to read it: look for documentation of a statistically appropriate sampling plan (randomization, sample size justification) and explicit discussion of heterogeneity. EURACHEM explains how sampling uncertainty can dominate total uncertainty when heterogeneity is high .
• Unresolved limits: many lab reports present results for the tested subsample only. Without a documented, appropriate sampling plan you cannot infer lot-wide properties. Sampling uncertainty and heterogeneity may remain large and unresolved for the lot, matrix, or date.
• Where to look: multi-parameter analytical evidence in the report (identity plus impurities profile, stable isotope or marker analyses where present), and VIP10 guidance on editorial standards for interpreting authenticity claims .
• What that evidence usually shows: whether the detected profile matches expected markers or contains unexpected adulterants; supporting chromatograms or spectra and any reference comparisons.
• How to read it: authenticity assessments require multiple lines of evidence—single-method identity testing is necessary but often insufficient. Check whether the report compares results to authenticated reference materials or expected marker patterns.
• Unresolved limits: authenticity claims remain conditional. Absence of specific adulterants in a tested sample does not prove all units are authentic. Certain sophisticated adulterations require targeted methods that may not be included; authenticity conclusions are therefore sample-, method-, matrix-, and date-specific.
• Where to look: official regulatory databases—e.g., Health Canada’s Drug Product Database for marketed, authorized drugs and product status .
• What that evidence usually shows: whether a drug product is listed, its authorized conditions of sale, and regulatory status in Canada.
• How to read it: search the Health Canada database for the exact product name, manufacturer, and formulation to confirm listed authorization. Regulatory listings may include authorized indications and marketing status.
• Unresolved limits: absence from a database entry for a specific product name or formulation does not alone prove illegality (nomenclature differences, formulation variants, or ongoing regulatory actions may complicate results). Lab analytics do not equate to regulatory authorization; authorization is determined by regulators based on their own records and criteria.
• Where to look: the methods, sample handling notes, measured purity/impurity data, and stability/expiry information in the lab report and VIP10’s commentary on reporting standards .
• What that evidence usually shows: whether the sample has known impurities, measured concentration, provided handling history, and whether data quality supports intended downstream experiments.
• How to read it: confirm that the report supplies enough material characterization (identity, quantitation, impurity profile, stability) for your experimental needs and that uncertainties are small enough for your planned analyses.
• Unresolved limits: suitability for a specific research protocol depends on that protocol’s tolerance for impurities and uncertainty. Analytical reports alone cannot certify a sample’s fitness for a given research purpose without matching the protocol requirements; conclusions remain sample-, method-, matrix-, and date-specific.
• Always read the methods, limits of detection/quantification, and uncertainty statements in the specific report before drawing conclusions. VIP10 outlines the editorial expectations for these elements ; EURACHEM explains how sampling contributes to uncertainty . Use Health Canada’s database to verify regulatory authorization claims where applicable .
• Explicit unresolved limits: none of the referenced report fields or databases, by themselves, proves sterility, safety, efficacy, Canadian authorization (unless confirmed in the regulator’s records), chain-of-custody integrity, or batch-wide uniformity. Each conclusion is conditional on the sampled unit, the analytical methods used, the matrix, and the date of sampling and analysis.