
| PRODUCT SPECIFICATIONS | |
|---|---|
| Name of Product | Methylthioninium Chloride |
| Pharmacopoeial Name | Methylthioninium Chloride BP |
| 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 | Must Pass A to D Tests Of B.P |
| 4 | Loss On Drying (At 75ËšC) | Limit: IN BETWEEN 8.0%-22.0% |
| 5 | Sulphated Ash Test | NMT 0.25% |
| 6 | Related Substances | Impurity A (Limit: Max.5.0%) Any other Impurity (Limit: Max.0.5%) Sum Of impurity Other then A (Limit: Max. 1.0%) Disregard Limit: Limit (0.1%) |
| 7 | Heavy Metals | Must Comply as per BP |
| 8 | Assay (With Reference To Subs. Dried At 105ËšC & As % Of (C 16H 18N 3ClS).H 2O |
MINIMUM 95.0% TO 101.0% MAXIMUM |
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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