GMP & ISO Certified Manufacturer of high quality Methylrosanilinium Chloride EP (Ph Eur) / BP.
Macsen Laboratories, world’s leading manufacturer and supplier of Methylrosanilinium Chloride EP (Ph Eur) / BP.
Macsen Laboratories, world’s leading manufacturer and supplier of Methylrosanilinium Chloride EP (Ph Eur) / BP.
SPECIFICATIONS
| SR. No | Criteria | Limit/Specification | Our Results |
|---|---|---|---|
| 1 | Appearance | Dark Green, Shiny Powder, Hygroscopic | Dark Green, Shiny Powder, Hygroscopic |
| 2 | Solubility | Sparingly Soluble in Water, Freely Soluble in Ethanol (96%) and In Methylene Chloride | Passes Test |
| 3 | Identification | Must Comply Identification Test A to C – As per E.P |
Passes Identification Test A to C – As per EP |
| 4 | N,N-Dimethylaniline | Limit: Max. 100 PPM | <100 PPM |
| 5 | Pentamethyl-P-Rosanilinium | Max. Limit 10.0% | 2.0 – 3.0 % |
| 6 | Related Substances | Impurity A (Limit Max.1.0%) Any other Impurity (Limit Max.0.1%) (Limit Max.0.1%) Sum Of impurity Other then A (Limit Max. 1.0%) |
0.3 -0.5 % a) NIL b) NIL 0% |
| 7 | Substances Insoluble In Ethanol (90% V/V) |
Limit: 0.5% | 0.2 – 3.5 % |
| 8 | Water | NMT 1.5% | 0.2 – 0.6 % |
| 9 | Assay (Anhydrous Substance) | MINIMUM 95.0% TO 103.0% MAXIMUM | 98.0 – 99.8% |
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