GST : 27AEJFS1005C1ZI
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Test Result
| Test | Specifications |
|---|---|
| Description | White to light yellow crystals |
| Solubility | Soluble in Methanol |
| Moisture content | NMT 0.5% |
| 1H-NMR | 115 Proton |
| Melting Point | 71-76ºC |
Test Result
| Test | Specifications |
|---|---|
| Appearance | Colourless crystals or white crystaline powder |
| Solubility | Freely soluble in ethanol (95%), in ether and in methanol. Very slightly soluble in water |
| Identification by IR | The Infrared absobrption spectrum of the sample should be concordant with the spectrum of methyl Paraben RS. |
| Appearance of Solution | A 10% w/v solution in ethanol (95%) is clear and not more intensely coloured than reference solution BYS6. |
| Acidity | NMT 0.1 ml of 0.1M sodium hydroxide is required to change colour of the solution |
| Related Substance by HPLC | Impurity A: NMT 0.5% |
| Unspecified impurities: NMT 0.5% | |
| Total impurities: NMT 1.0% | |
| Chlorides | NMT 500 ppm |
| Sulphates | No turbidity is produced whithin 10 minutes |
| Sulphated ash | NMT 0.1% |
| Assay, By HPLC (as C8H8O3) | 98.0% to 102% |
Test Result
| Test | Specifications |
|---|---|
| Description | Off White to Grayish White to Brown Powder |
| Solubility | Soluble in Dichloromethane and Methanol |
| Water by KF | N.M.T 1.0% |
| Melting Range | 60 to 65 C |
| Purity By GC | N.L.T 98.00% |
