Methylrosanilinium Chloride EP (Ph Eur) / BP

METHYLROSANILINIUM CHLORIDE EP (Ph Eur) / BP

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PRODUCT SPECIFICATIONS
Name of Product Methylrosanilinium Chloride
Pharmacopoeial Name Methylrosanilinium Chloride EP (Ph Eur) / BP
Synonyms Gentian Violet ; Crystal Violet ; Basic Violet 3
CAS No 548-62-9
Pubchem CID 11057
Pubchem SID 462768911
GMP
DMF

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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