TESTS |
SPECIFICATION |
RESULT |
|
|
|
|
Soluble in water, in 0.1 N HCl, and in Alcohol. |
|
 |
|
|
|
 I. R. Spectrum |
Should comply |
| |
|
| By HPLC |
Should comply |
|
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| TEST 1 (By TLC) |
|
| |
|
| m-chlorobenzoic acid NMT 0.2 % |
NMT 0.2% |
| |
|
| Any other impurity NMT |
NMT 0.1% |
| |
|
| TEST 2 (By HPLC) |
|
| |
|
| Total unidentified impurities |
NMT 0.3% |
| |
|
| Total Impurities (From Test 1 & Test) 2) |
NMT 1.0% |
|
|
|
|
| 0.3% |
| |
Not detected
|
| |
Not detected
|
| |
| |
| |
0.04%
|
| |
0.04%
|
|
|
|
|
| 12.6 % to 13.1 |
12.6 % to 13.1% |
|
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| LIMIT OF HALOPERIDOL RELATED COMPOUND ‘A’ |
|
|
|
| By UV Spectrophotometry |
NMT 1.0% |
|
|
|
|
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|
| By Titrimetry |
98.0% to102.0% |
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| ORGANIC VOLATILE IMPURITIES |
|
|
|
| Chloroform |
NMT 60 ppm |
| |
|
| 1,4 dioxane |
NMT 380 ppm |
| |
|
| Methylene chloride |
NMT 600 ppm |
| |
|
| Trichloroethylene |
NMT 80 ppm |
| |
|
|
|
|
|
| Not detected |
| |
| Not used in the process and not detected when tested
|
|
|
|
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| |
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| Methanol |
NMT 3000 ppm |
| Toluene |
NMT 890 ppm |
| Dichloro methane |
NMT 600 ppm |
| Ethyl acetate |
NMT 5000 ppm |
| Hexane |
NMT 290 ppm |
| Acetonitrile |
NMT410 ppm |
|
|
|
|
| |
| Not detected |
| Not detected |
| Not detected |
| Not detected |
| Not detected |
| Not detected |
| |
|
|
|
