| Sodium Citrate USP/Ph.Eur PARENTEX 5KG | |||
| P1580SR500 | 42490B509LW | ||
| USP/Ph.Eur PARENTEX | 42490B5 | ||
| 6132-04-3 | 101175 | ||
| C6H5Na3O7.2H2O | December 2023 | ||
| 294.1 | November 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Colorless crystalline powder, slightly deliquescent in moist air. | Colorless crystals or white, crystalline powder/ granular crystals, slightly deliquescent in moist air. |
| 2 | Solubility | Complies | Freely soluble in water & very soluble in boiling water. Insoluble in alcohol & Practically insoluble in ethanol (96%) |
| 3 | Identification (Citrate) | Complies | Solution should produce violet colour turning to violet blue |
| 4 | Identification (Citrate ) | Complies | A light red color should produce |
| 5 | Identification(Sodium) | Complies | A dense white precipitate should form. |
| 6 | Identification (reaction upon ignition) | Complies | Upon ignition, it should yield an alkaline residue that effervesces when treated with 3N hydrochloric acid |
| 7 | Appearance of Solution | Complies | Clear and colourless solution |
| 8 | Acidity or alkalinity | Complies | Not more than 0.2 mL of 0.1M hydrochloric acid or 0.1 M sodium hydroxide is required to change the color of the indicator |
| 9 | Alkalinity | Complies | No pink colour is produced by 1 drop of phenolphthalein. |
| 10 | Readily carbonizable substances | Complies | The solution is not more intensely coloured than reference solution Y2 or GY2. |
| 11 | Chlorides | Less than 50ppm | NMT 50ppm |
| 12 | Oxalate | Less than 300ppm | NMT 300ppm |
| 13 | Sulphate (SO4) | Less than 150ppm | NMT 150ppm |
| 14 | Water (By KF) | 11.7% | 11.0%-13.0% |
| 15 | Water (At 180°C for 18h) | 11.8% | 10.0% -13.0% |
| 16 | Assay (Anhydrous basis) | 100.2% | 99.0%-101.0% |
| 17 | Assay (on Anhydrous basis) | 100.0% | 99.0%-100.5% |
| 18 | Tartrates | Complies | No crystalline precipitate is formed. |
| 19 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
| Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |
Computer Generated Report - Does not require Signature.
