| Citric Acid Anhydrous USP/Ph.Eur PARENTEX 5KG | |||
| P0489SR500 | 45068B515LX | ||
| USP/Ph.Eur PARENTEX | 45068B5 | ||
| 77-92-9 | 113613 | ||
| C6H8O7 | December 2024 | ||
| 192.13 | November 2027 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | White crystalline powder. | Colorless, translucent crystals; white or almost white granular to fine crystalline powder.(Note: The product may cause lumps or hardening over the storage). | USP/Ph.Eur |
| 2 | Solubility | Complies | Very soluble in water, freely soluble in ethanol (96%) and alcohol ,very slightly soluble in ether. | USP/Ph.Eur |
| 3 | Melting point | 153.6°C | About 153°C, with decomposition. | Ph.Eur |
| 4 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of standard | USP/Ph.Eur |
| 5 | Identification (By chemical test 1) | Complies | The solution should be strongly acidic. | Ph.Eur |
| 6 | Identification (By chemical test 2) | Complies | A red colour should develop. | Ph.Eur |
| 7 | Identification (By chemical test 3) | Complies | A white precipitate should form. | Ph.Eur |
| 8 | Identification (By Water) | 0.17% | NMT 1.0% | Ph.Eur |
| 9 | Appearance of Solution | Complies | The solution should be clear and colourless or not more intensely coloured than reference solution Y7, BY7 or GY7. | Ph.Eur |
| 10 | Clarity of solution | Complies | The sample solution should show the same clarity as that of water or its opalescence is not more pronounced than standard suspension A. | USP |
| 11 | Colour of solution | Complies | The sample solution should not more intensely colored than standard solutions | USP |
| 12 | Readily carbonizable substances | Complies | The solution should not be more intensely coloured than reference standards | USP/Ph.Eur |
| 13 | Oxalic acid | Less than 360 ppm | NMT 360ppm | USP/Ph.Eur |
| 14 | Sulfates | Less than 150 ppm | NMT 150ppm | USP/Ph.Eur |
| 15 | Water | 0.17% | NMT 1.0% | USP/Ph.Eur |
| 16 | Sulphated ash / Residue on ignition | 0.06% | NMT 0.1% | USP/Ph.Eur |
| 17 | Assay (Anhydrous basis) | 99.87% | 99.5%-100.5% | USP/Ph.Eur |
| 18 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 19 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm | In-house |
| 20 | Bacterial endotoxin test | Less than 0.5 EU/mg | NMT 0.5 EU/mg | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur SPECIFICATION.
Actylis 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.
