| Silver Sulphadiazine U.S.P. 25 | |
| Specification | For : Silver Sulphadiazine U.S.P. |
| Test | Specification |
| Description | Fine white powder |
| Identification | A) I. R. Test passes B) T.L.C. Passes C) Passes |
| Chromatographic Purity | Sum of all secondary spots is Max. 2% |
| Nitrate | Limit: Max.0.1 % |
| Particle Size | Limit : Less than 10 microns |
| Loss on drying (At 105 0 C) | Limit ; Max. 0.5 % |
| Sulphadiazine Content | Limit : Around 70% |
| Silver Content | Limit : Between 29.3 % to 30.5 % |
| Assay | Limit:98% to 102% |
| (On Dried Basis) | |
| (By H.P.L.C.) | |
| Picosulfate Sodium BP / USP | |
| Specification | For : Picosulfate Sodium BP |
| Test | Specification |
| Description | A white or almost white crystalline powder |
| Identification | A) I. R. should confirm B) TLC as per Related Substance C)Chemical Test D)Chemical Test E) Gives reaction of Sodium |
| Solubility | Freely soluble in water, slightly soluble in alcohol |
| Appearance of Solution | The solution should clear and not more intensely colored than reference solution GY7 |
| Acidity Or Alkalinity | The solution is colourless. NMT 0.25 ml of 0.01 M NaOH is required to change the colour of the indicator of peak |
| Related Substance | Limit : Max. 0.2% |
| Chloride | Limit : Max. 200 PPM |
| Sulphate | Limit : Max. 400 PPM |
| Heavy Metals | Limit: Max. 1 PPM |
| Water Content | Limit : 3.0% - 5.0% |
| Assay O.D.B. (by Titration) | Limit: 98.5 % to 100.5% |
| Alendronate Sodium BP | |
| Specification | For : Sodium Alendronate BP or 4-Amino 1-Hydroxy Butylidene Bis Phosphonic Acid Mono Sodium Salt Tri Hydrate |
| Test | Specification |
| Description | White crystalline powder, Odourless, Tasteless |
| Identification | A) I. R. Test should complies with IR of standard. |
| Solubility | Soluble in water very slightly soluble in Methanol, practically insoluble in Methylene Chloride |
| Appearance of Solution | Clear and colour less solution |
| Heavy Metals | Limit: Max.20 PPM |
| Ph (1% Solution) | Limit between 4.0 to 5.0 (0.5 Gms in 50 ML Water) |
| 4 - Amino Butanoic Acid (By TLC) | Limit: Max.0.5% |
| Phosphate and Phosphite (By H.P.L.C.) | Limit: Max.0.5% |
| Loss on drying (at 140° C to 145°C) | Limit: 16.1% to 17.1% |
| Assay (On Dried Basis) (By H.P.L.C.) (By Titration) |
Limit: 98% to 102% |
