| Phenytoin Base B. P | |
| Specification | For : Phenytoin Base B. P |
| Test | Specification |
| Description | Almost white crystalline powder, odourless |
| Identification | A) I. R. Test passes B) T.L.C. Test Passes C).Test Passes D).Test Passes |
| Solubility | Practically insoluble in water, sparingly soluble in alcohol, very slightly soluble in Methylene chloride |
| Clarity And Color of Solution | Clear & colorless solution |
| Acidity Or Alkalinity | As per B.P. |
| Related Substance | As per B.P. |
| Heavy Metals | Limit: 10 PPM |
| Loss On Drying | Limit : Max. 0.5% |
| Sulphated Ash | Limit :Max. 0.1% |
| Assay | Limit: 99 % to 101% |
| Phenytoin Sodium BP / EP | |
| Specification | For : Phenytoin Sodium BP / EP |
| Test | Specification |
| Description | A white, crystalline power, hygroscopic |
| Identification | A) I. R. Test passes B) Test passes C) Test passes |
| Clarity And Colour of Solution | As per BP |
| Heavy Metals | Limit: Max.10 PPM |
| Free Phenytoin | Limit : 0.1 normal NaoH Sodium Hydroxide |
| Related Substance/TLC | By TLC Passes |
| Water Content | Limit : Max. 3.0% |
| Assay | Limit : 98.5% to 100.5% |
| Propyl Gallate BP / EP | |
| Specification | For : Propyl Gallate B.P |
| Test | Specification |
| Description | White or almost white crystalline powder |
| Identification | A) Melting point : Limit :148
0C to 151 0C B) TLC for Gallic Acid C) Chemical Test |
| Solubility | Very slightly soluble in water, freely soluble in ethanol (96%). It dissolves in dilute solution of Alkali hydroxide. |
| Appearance of Solution | 5% w/v solution of sample in alcohol is clear. |
| Gallic acid | Limit : Max. 0.5% |
| Chlorine | Limit : Max.200 PPM |
| Total Chloride | Limit : Max.100 PPM |
| Zinc (Atomic Absorption Spectrometry) | Limit : Max. 25 PPM |
| Heavy Metals | Limit : Max.10 PPM |
| Loss on drying | Limit: Max. 0.5% |
| Sulphated Ash | Limit : Max..0.1 % |
| Assay | Limit: 97% to 103% |
