# Methylene blue grade and documentation worksheet

Supplier: ____________________
Product and form: ____________________
Product batch: ____________________
Ingredient batch: ____________________
Date checked: ____________________
Checked by: ____________________

## 1. Define the conformity claim

- [ ] Exact material covered by the claim is identified.
- [ ] Monograph title is recorded: ____________________
- [ ] Official version and effective date are recorded: ____________________
- [ ] Supplier confirms applicable General Notices and general chapters.
- [ ] Any proposed, historical, or alternative specification is identified separately.

Reference reviewed for this worksheet: USP Methylene Blue revision bulletin, official September 1, 2023. Check the current official text at procurement. A 2026 proposal is not itself a replacement official standard.

Monograph: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/methylene-blue-rb-notice-20230831.pdf
Proposal: https://doi.usp.org/USPNF/USPNF_M52480_70101_01.html

## 2. Reconcile the testing records

For each requirement, enter the report identifier, result, limit, method, and any unresolved gap. Copy actual results; do not enter “passes” based only on a marketing page.

| Evidence | Report / result / method | Gap or follow-up |
|---|---|---|
| Infrared, chromatographic, and chloride identity | | |
| Assay and dried-basis calculation | | |
| Azure B and other organic impurities | | |
| Drying loss and ignition residue | | |
| Microbial counts and applicable endotoxin control | | |
| Applicable elemental-impurity and other general requirements | | |
| Packaging, storage, and relevant labeling | | |

Record whether each report concerns the ingredient, a bulk solution, or the finished packaged product: ____________________

## 3. Match the lot

- [ ] Product batch maps to the tested ingredient batch.
- [ ] Report identifies the laboratory, material, dates, and batch.
- [ ] Actual results are distinguishable from acceptance limits.
- [ ] Finished-product claims have finished-product evidence.
- [ ] Retest/expiry and storage information are appropriate to the supplied material.

Document establishing product-to-ingredient link: ____________________

## 4. Verify additional claims separately

| Claim | Named authority/program | Exact covered entity | Current confirming record |
|---|---|---|---|
| USP verification, if claimed | | | |
| Product authorization, if claimed | | | |
| Other certification, if claimed | | | |

For product authorization, match jurisdiction, applicant, product, strength, dosage form, route, and labeling. A COA or NDC listing does not substitute for an approval record.

## 5. Record the purchasing conclusion

Evidence obtained: ____________________
Unresolved gaps: ____________________
Supplier response needed: ____________________
Decision and reason: ____________________

This worksheet documents evidence. It does not certify a batch or establish treatment suitability.