Methylene Blue API
| CAS No. | 7220-79-3 |
| Therapeutic Category | Detoxification |
| Technology | Synthetic |
| Dosage Form | injection |
| Innovator Brand | Provayblue(France） |
| Registration Status | USD/ DMF |
| Polymorph | / |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name:3,7-bis(Dimethylamino)-phenothiazin-5-ium chloride
- Molecular Formula:C16H20ClN3OS
- Molecular Weight:337.87
- Specification: Enterprise Standard established according to ChP/USP/EP
- Appearance: Powder
- Total impurities: not more than 0.5%
- Purity: not less than 99%
- Residual Solvents: fully comply with ICH Q3C
- Mutagenic impurities: fully comply with ICH M8
- Nitrosamine assessment: available
- Particle size: regular grade or milling/sieving according to customer’s requirement.
- Storage: Room temperature
- Production capacity: Commercial
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of Methylene Blue API
- Methylene blue is an oxidation-reduction agent used to treat methemoglobinemia, a condition where hemoglobin is oxidized, impairing its ability to carry oxygen. Methylene blue works by reducing the oxidized hemoglobin, converting it back to hemoglobin so that it can carry oxygen properly again. Methemoglobinemia can lead to symptoms like cyanosis, fatigue, and shortness of breath.
Why Choose Us as Your Methylene Blue API Manufacturer?
- Qingmu’s Methylene Blue API has been filed in China(DMF filed and listed on CDE’s website), DMF in CTD format is available and can be supported for registration worldwide.
- Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to remove factory. A new API factory is under design and is predicted to be put into use in 2025.
- As a China manufacturer, Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
- Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA) and MFDS(Korea) and also customer audits from Europe, USA and Japan, etc.
- Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. So please feel free to choose us.
