METHYLENE BLUE CERTIFICATE OF ANALYSIS: REVIEW CHECKLIST
Blupreme | English | Version 2026-09-12

Use one copy per bottle batch and report. Mark each item YES, NO or UNKNOWN.
This worksheet records documentary evidence; it is not a laboratory result.

1. IDENTIFY THE PURCHASE AND SAMPLE
Supplier:
Product and formulation:
Bottle batch:
Ingredient batch:
Laboratory sample identifier:
Report number and revision:
Report source URL / saved filename:
Date reviewed:
[ ] The report names the tested material and its physical form.
[ ] The report identifies whether the sample was ingredient or finished product.
[ ] The lot matches my purchase or a written batch-linking record connects them.
Location of the batch-linking record:
Who collected and submitted the sample:
Sampling history still unknown:

2. CHECK THE ISSUER AND DATES
Certificate issuer and contact details:
Laboratory that actually performed each test:
Original manufacturer, if different:
Sample receipt / testing / release dates:
Retest or expiration date and applicable storage conditions:
Authorized approver:
Accreditation number and scope, if claimed:
[ ] Dates are consistent with the sample and product history.
[ ] I have distinguished retest dating from opened-bottle shelf life.
[ ] Claimed accreditation covers the relevant test and sample type.
[ ] Any underlying or subcontracted laboratory reports are identified.

3. REVIEW EACH RELEVANT TEST
Copy this block once per analyte or test.
Test / analyte:
Sample type:
Method / procedure identifier and revision:
Units and calculation basis (for example dried basis):
Acceptance criterion:
Reported result, including < or > signs:
Detection / quantitation / reporting threshold, where applicable:
Meaning of abbreviations or qualifiers:
Does the result establish compliance with the stated criterion? YES / NO / UNKNOWN
Reason:

[ ] Identity and concentration/assay are treated as different measurements.
[ ] I compared each result with its own limit, using matching units and basis.
[ ] I did not treat ND, below-limit results or blank fields as zero.
[ ] The reporting threshold is low enough to answer the acceptance question.
[ ] I did not treat one passing test as evidence for tests not performed.

4. RECORD DOCUMENT LIMITS
Does this report apply only to the submitted sample?
Missing methods, dates, original reports or sampling records:
Claims about the finished product not established by the ingredient report:
Claims about independent testing not established by the named issuer alone:
Other qualifications, amendments or limitations:

5. REQUEST MISSING DOCUMENTATION
Suggested request:
Please provide the complete COA associated with bottle batch __________,
the record linking it to the tested sample, and the identity of the laboratory
that performed the work. Include methods, limits, numerical results and reporting
thresholds. If the report covers the ingredient, identify which records or tests
cover the finished solution.

Date requested:
Response and supporting files:
Unresolved questions:
Next action:

Reading guide:
/en/articles/read-methylene-blue-certificate-of-analysis/
Pharmaceutical ingredient COA benchmark: FDA ICH Q7, section 11.4
https://www.fda.gov/media/71518/download