| Amlodipine Besilate BP | |
| Specification | For : Amlodipine Besilate BP |
| Test | Specification |
| Description | White or almost white powder |
| Identification | A) Infrared Absorption spectrophotometry B) TLC C) Specific Absorbance Max 360 nm 113-121 |
| Solubility | Slightly soluble in water, freely soluble in Methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol. |
| Ooptical Rotation | - 0.10o to + 0. 10o |
| Related Substance by 1) TLC 2) Liquid chromatography a. Impurity D b. Other Impurities |
It should complies as prescribed test a. Max. 0.3% b. Max. 0.3% |
| Water Content | Limit: Max. 0.5% |
| Sulphated Ash | Limit : Max. 0.2% |
| Assay (Anhydrous basis) | Limit : 97% & 102% |
| Pamidronate Disodium | ||
| Specification | For : Pamidronate Disodium | |
| Chemical Name | Disodium Dihydrogen(3-Amino-1- Hydroxy Propylidene) Bisphosphonate Pentahydrate | |
| Test | Specification | |
| Description | White or almost white crystalline powder | |
| Solubility | Soluble in water, practically insoluble in methylene chloride. It is sparingly soluble in dilute minerals acids and dissolves in dilute alkaline solutions. | |
| Identification | A) Infrared absorption spectrophotometry B) Gives reaction of sodium. | |
| Appearance of solution | The solution is clear and not more intensely coloured than reference solution Y6 | |
| pH ( 1% w/v in water) | Limit: 7.8 to 8.8 | |
| Impurity A | Limit : Max. 0.5% | |
| Impurity B & C | Limit : Max. 0.5% | |
| Heavy Metals | Limit : Max. 20 PPM | |
| Water | Limit : Between 23% - 27% | |
| Assay | Limit : 98 % to 101% | |
| (On anhy. basis) | ||
| Methylene Blue EP | ||
| Specification | For : Methylene Blue EP | |
| C.I. No. | 52015 | |
| CAS No. | 61-73-4 | |
| Test | Specification | |
| Description | Dark greenish powder | |
| Identification | A) Test passes B) Test passes C) Test passes D) Test passes | |
| Solubility 0.1% (Water) | Clear Blue Solution, Soluble in water, slightly soluble in Alcohol, practically insoluble in Ether | |
| Absorptivity 1%, 1cm, at λ Max. 664.0nm | Limit : 2200-2750 | |
| Methanol Insoluble Substances | Limit: Max.1.0% | |
| Related Colorants | As per EP | |
| Heavy Metals | Limit: Max. 20PPM | |
| Iron | Limit : Max.100PPM | |
| Zinc | Limit: Max.100PPM | |
| Loss On Drying (At 110° C) | Limit: 10-15% | |
| Sulfated Ash | Limit : Max. 0.25% | |
| Assay | Limit: 95% to 101% | |
| (On Dried Basis) | ||
