| Tizanidine HCl USP | ||
| Specification | For : Tizanidine Hydrochloride U.S.P | |
| Test | Specification | |
| Description | A white to off white crystalline powder | |
| Solubility | Soluble in water and methanol, practically insoluble in acetone, chloroform, ethyl acetate. | |
| Identification | ||
| A) IR Spectrum | IR absorption spectrum of sample in KBR dispersion is concordant with that of reference standard of Tizanidine HCL | |
| B) HPLC | The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay | |
| Ph (A 1% W/V Aqueous Solution) | Limit between 4.3 to 5.3 | |
| Loss On Drying (At 105 0 FOR 3 HRS) | NMT 0.5 % w/w | |
| Residue on Ignition | NMT 0.1% w/w | |
| Heavy Metals | Not more than 0.002% | |
| Related Substance (By HPLC) | ||
| Tizanidine related compound C | Not more than 0.1% | |
| Tizanidine related compound B | Not more than 0.1% | |
| Tizanidine related compound A | Not more than 0.1% | |
| Individual unknown impurity | Not more than 0.1% | |
| Total impurities | Not more than 0..3% | |
| Organic volatile impurities | Meets the requirement | |
| Content of Chloride | NLT 11.9% & NMT12.5% | |
| Assay (By Titration) | Limit: 98.0 % TO 102.0 % w/w | |
| (On Dried Basis) | ||
| Risedronate Sodium | |
| Specification | For : Risedronate Sodium |
| Chemical Name | Sodium Salt of [1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic acid |
| CAS No | 115436-72-1 |
| Molecular Formula | C7H10NNaO7P2 |
| Molecular Weight | 305.11 |
| Merck Index No | 8315 |
| Test | Specification |
| Description | White to off white Crystalline powder |
| Identification | A) I.R. absorption Spectrum |
| Solubility | Soluble (1%) in 0.1 M sodium hydroxide, Sparingly soluble in water, very slightly soluble in ethanol and in dimethyl formamide |
| Clarity and colour of solution (1% w/v in 0.1N NaOH) |
Clear and colourless |
| pH of a 1% in w/v solution in Water | Limit : 4.2 – 5.2 |
| Loss on Drying | Limit : 11.5% - 13.5% |
| Heavy Metals | Limit : Max. 20 PPM |
| Related Substances a) Pyridine – 3 acetic acid (by HPLC) b) Phosphite content (by titrimetry) |
Limit : Max. 0.25 Max..1.0 |
| Assay (by HPLC) (On anhydrous basis) | Limit : 98.0% to 102.0% |
