| TESTS |
SPECIFICATIONS |
REFERENCE |
| |
| Description |
A White Crystalline Powder & Odourless. |
IP/BP/USP |
|
| |
| Solubility |
Very soluble in water; Freely Soluble in Chloroform and in ethanol (95 %); Practically insoluble in ether. |
IP |
| Very soluble in water; Freely Soluble in alcohol. |
BP |
| |
| Identification |
To Comply IR test. Test (B), (C), (D), & (E) are complies as per IP.
(F) It Melts Between 740 to 790 C.
|
IP |
| |
|
First identification A, B, F. Second Identification A, C, D, E, F.
(A) Melting Point : Between 740 to 790 C.
To Comply IR test. Test (C), (D), (E) & (F) are complies as per BP
|
BP |
| |
(A) To Comply test as per USP
(B) Its give Chloride test. |
USP |
| |
| Melting Point |
Between 740 and 790 C . |
USP |
| |
| Clarity of solution |
A 5.0 % w/v solution in Carbon dioxide-free water is clear & Colourless |
BP/IP |
| |
| pH |
Between 4.0 to 5.5 |
BP/IP |
| |
| 2,6-Dimethylaniline |
To Comply test as per IP |
IP |
| |
| Impurity-A |
Not more than 100 ppm. |
BP |
| |
| Residue on ignition |
Not more than 0.1 % w/w |
USP |
| |
| Chloride |
Not more than 35 ppm |
BP/USP |
| |
| Sulphate |
To Comply test as per USP/ To comply test as per IP |
USP/IP |
| |
| Sulphated Ash |
Not more than 0.1 % w/w. |
IP/BP |
| |
| Heavy Metal |
Not more than 20 ppm/ Not more than 10 ppm / To comply test as per BP |
USP/IP/BP |
| |
| Water |
Between 5.0 and 7.0 % w/w. / Between 5.0 and 7.5 % w/w. / Between 5.5 and 7.0 % w/w. |
USP/IP/BP |
| |
| Assay |
NLT 97.5 % and NMT 102.5 % of C14H22N2O.HCl, on dried basis. / NLT 99.0 % and NMT 101.0 % of C14H22N2O.HCl, on dried basis. |
USP/BP/IP |
