
| PRODUCT SPECIFICATIONS | |
|---|---|
| Name of Product | Methylthioninium Chloride |
| Pharmacopoeial Name | Methylthioninium Chloride E.P-10 |
| Synonyms | Methylene Blue ; Basic Blue 9 ; C.I 52015 ; Methylene Blue Trihydrate |
| CAS No | 122965-43-9 |
| WHO-GMP | ✓ |
| WC | ✓ |
| DMF | ✓ |
| US-DMF | ✓ |
| SR. No | Criteria | Limit/Specification |
|---|---|---|
| 1 | APPEARANCE | Dark Blue Crystalline Powder with a Copper- colored Sheen, or Green Crystals with a bronze-colored sheen. |
| 2 | SOLUBILITY | Must Pass Test |
| 3 | IDENTIFICATION TEST A. Infrared(IR) Absorotion B. Identification of Chloride |
The IR Spectrum is concordant with the reference spectrum of Methylene Blue Gives reaction (a) of chlorides |
| 4 | LOSS ON DRYING | Limit: IN BETWEEN 8.0% to 24.0% |
| 5 | METALS ALUMINIUM CADMIUM CHROMIUM COPPER TIN IRON MANGANESE MERCURY MOLYBDENUM NICKEL LEAD ZINC |
NMT 100 PPM NMT 1 PPM NMT 100 PPM NMT 300 PPM NMT 10 PPM NMT 200 PPM NMT 10 PPM NMT 1PPM NMT 10 PPM NMT 10 PPM NMT 10 PPM NMT 100 PPM |
| 6 | SULPHATED ASH TEST | 0.25% |
| 7 | RELATED SUBSTANCES | Impurity A (Azure-B) [Relative RT-0.8, Acceptance Criteria NMT(%)-5.0] Unspecified impurity-01[Relative RT-0.6, Acceptance Criteria NMT(%)-0.10] Total Impurities(Excluding Azure-B) [Relative RT--, Acceptance Criteria NMT(%)-0.5] |
| 8 | ASSAY (BY HPLC) (On Dried Basis) |
93.0% - 102.0% |
The Indian Patent Office granted a patent to Mr Achal Agrawal, CEO of Macsen Labs, Udaipur. The title of the patent is Novel Improved Method for Synthesis of Diaminophenothiazine Compounds and it concerns a novel process for synthesising the compound Methylthioninium Chloride or Methylene Blue. Macsen Labs has now achieved a unique position by this patent and from now nobody will be able to copy this process. Read more
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