# Methylene blue formulation comparison and supplier worksheet

Purpose: compare labeled amount, formulation, documentation, and handling. This worksheet does not rank absorption or specify an amount to take. Prepared 2026-09-12.

| Format | Unit label | Ingredients to check | Finished-product evidence | Handling check |
| --- | --- | --- | --- | --- |
| Capsule | mg/capsule; capsules/serving | Shell, fill, added active ingredients | Assay; uniformity; release; stability | Swallowing; instructions about opening |
| Tablet | mg/tablet; release designation; subdivision instructions | Core and coating | Assay; uniformity; dissolution/disintegration; supported splitting | Avoid assuming crushing or splitting is permitted |
| Liquid | mg/mL; concentration basis; serving volume | Solvent, preservative, flavors, added actives | Concentration; relevant impurities and microbial tests; packaging/stability | Measuring device; leaks; spills; staining |
| Oral strip | mg/strip; strips/serving; stated route | Film, plasticizers, sweeteners, flavors | Uniformity; disintegration; moisture stability; human absorption evidence if claimed | Individual packaging; storage; no assumed accurate cutting |
| Lozenge | mg/lozenge; serving; stated administration | Base, sugar/sweeteners, flavors, added actives | Uniformity; release; human absorption evidence if claimed | Oral contact; swallowing behavior; packaging |

Record the exact document or label wording. Write “not supplied” when evidence is missing rather than assuming a pass.

| Comparison field | Candidate A | Candidate B |
| --- | --- | --- |
| Product and supplier | | |
| Intended use and local authorization/status evidence | | |
| Exact active ingredient and chemical/assay basis | | |
| Amount per complete unit or per mL | | |
| Units or volume per labeled serving | | |
| Full ingredients including shell/coating | | |
| Immediate, delayed, prolonged release, or unspecified | | |
| Intended route and administration instructions | | |
| Lot number on package | | |
| Matching finished-product report and date | | |
| Identity and assay result, method, units, limits | | |
| Unit uniformity evidence, if relevant | | |
| Dissolution/disintegration evidence, if relevant | | |
| Relevant impurities and microbial results | | |
| Stability, expiry, storage, packaging evidence | | |
| Human absorption claim: actual product, route, comparator, population, endpoint | | |
| Measuring device or subdivision instructions | | |
| Unanswered supplier questions | | |

Evidence principles: [ICH M13A bioequivalence guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m13a-bioequivalence-immediate-release-solid-oral-dosage-forms), [FDA tablet-splitting advice](https://www.fda.gov/drugs/buying-using-medicine-safely/tablet-splitting), and [the tested aqueous oral methylene blue study](https://pubmed.ncbi.nlm.nih.gov/18810398/). This is an original editorial comparison, not a report of tests performed on either candidate.