Methylene Blue 1% Solution - Product & Safety Information
UFC BIO Methylene Blue 1% Solution is a standardized aqueous preparation containing methylene blue and high-purity water. It is manufactured under controlled conditions and each production lot is evaluated against established quality specifications.
The methylene blue raw material is tested to applicable USP specifications. Lot-specific analytical documentation is available.
Product Composition
| Component | Description |
|---|---|
| Methylene Blue | 1.0% w/v |
| Concentration | 10 mg/mL (~0.5mg/drop) |
| Water | Purified Water, USP |
| Appearance | Clear blue solution |
| Package Size | 100 mL |
| Storage | Store at controlled room temperature and protect from light |
Quality Specifications
Each production lot is evaluated against established product specifications. Testing may include:
- Identity
- Methylene blue concentration/assay
- UV/Visible spectral characteristics
- Appearance
- Selected elemental impurities
- Other applicable quality attributes
Refer to the lot-specific Certificate of Analysis for the actual specifications and test results applicable to your product.
Certificate of Analysis
Lot-Specific Certificate of Analysis
Use the lot number printed on the bottle to locate the applicable Certificate of Analysis.
[View / Search Certificate of Analysis]
Safety Data Sheet
The Safety Data Sheet provides information regarding safe handling, storage, accidental exposure, and disposal.
[View Safety Data Sheet]
Important Medication Interaction Information
Methylene blue has pharmacologic activity and can interact with certain medications.
FDA-approved methylene blue drug labeling warns that serious or fatal serotonin syndrome has occurred when methylene blue class products were used with serotonergic medications. These include certain:
- SSRIs and SNRIs
- MAO inhibitors
- opioids
- dextromethorphan
- other serotonergic medications
Individuals taking prescription or over-the-counter medications should discuss methylene blue use with an appropriately qualified healthcare professional or pharmacist before use. Current FDA labeling for methylene blue specifically identifies serotonergic drugs and opioids as important interaction risks. DailyMed
G6PD Deficiency
Methylene blue may present particular risks for individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. FDA-approved methylene blue labeling describes reduced effectiveness and a risk of hemolytic anemia in patients with G6PD deficiency. DailyMed
Individuals with known or suspected G6PD deficiency should consult an appropriately qualified healthcare professional before considering use.
Pregnancy and Breastfeeding
Pregnant or breastfeeding individuals should consult an appropriately qualified healthcare professional before considering methylene blue.
FDA-approved methylene blue drug labeling warns that methylene blue may cause fetal harm and provides specific precautions regarding breastfeeding following pharmaceutical treatment. These warnings are based primarily on approved pharmaceutical methylene blue products and do not establish the safety of this 1% oral product during pregnancy or breastfeeding.