| Citric Acid Monohydrate USP/Ph.Eur 5K | |||
| 97490SR500 | 453717125AY | ||
| USP/Ph.Eur | 4537171 | ||
| 5949-29-1 | 109589 | ||
| C6H8O7.H2O | January 2025 | ||
| 210.14 | December 2027 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | Colourless, translucent crytals, efflorescent. | Colourless, translucent crystals or white or almost white granular to fine crystalline powder, efflorescent.(Note: The product may cause lumps or hardening over the storage). | USP/Ph.Eur |
| 2 | Solubility | Complies | Very soluble in water, freely soluble in alcohol and ethanol(96%), very slightly soluble in ether, | USP/Ph.Eur |
| 3 | Identification (By chemical test 1) | Complies | The solution should be strongly acidic. | Ph.Eur |
| 4 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standadrd | USP/Ph.Eur |
| 5 | Identification (By chemical test 2) | Complies | A red color should develop. | Ph.Eur |
| 6 | Identification (By chemical test 3) | Complies | A white precipitate should form. | Ph.Eur |
| 7 | Identification (By Water) | 8.35% | 7.5% to 9.0% | Ph.Eur |
| 8 | Appearance of solution | Complies | The solution is clear and colourless or not more intensely coloured than reference solution Y7, BY7 or GY7. | Ph.Eur |
| 9 | Clarity of solution | Complies | The sample solution shows the same clarity as that of water or its opalescence is not more pronounced that standard suspension A. | USP |
| 10 | Colour of solution | Complies | The sample solution is not more intensely colored than water or standard solutions A, B, and C . | USP |
| 11 | Assay (Anhydrous basis) | 99.8% | 99.5% - 100.5% | USP/Ph.Eur |
| 12 | Residue on ignition /Sulfated ash | 0.05% | NMT 0.1% | USP/Ph.Eur |
| 13 | Sulphate(SO4) | Less than 0.015% | NMT 0.015% (NMT 150 ppm) | USP/Ph.Eur |
| 14 | Limit of oxalic acid | Less than 0.036% | NMT 0.036% (NMT 360 ppm) | USP/Ph.Eur |
| 15 | Readily carbonizable substances | Complies | The color of the acid should not be darker than that of a similar volume of matching reference solution A (fluid K) or reference solution B. | Ph.Eur |
| 16 | Water | 8.35% | 7.5% to 9.0% | USP/Ph.Eur |
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP AND 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.
