| Citric Acid Monohydrate USP/Ph.Eur/BP PARENTEX PLUS 5KG | |||
| I0490SR500 | 42311B119KW | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 42311B1 | ||
| 5949-29-1 | 101375 | ||
| C6H8O7.H2O | November 2023 | ||
| 210.14 | October 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Colourless, translucent crystals. | Colourless, translucent crystals or white or almost white granular to fine crystalline powder, efflorescent. |
| 2 | Solubility | Complies | Very soluble in water, freely soluble in alcohol and ethanol(96%), very slightly soluble in ether, |
| 3 | Identification (By chemical test 1) | Complies | The solution is strongly acidic. |
| 4 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standadrd |
| 5 | Identification (By chemical test 2) | Complies | A red colour should develop. |
| 6 | Identification (By chemical test 3) | Complies | A white precipitate should form. |
| 7 | Identification (By Water) | 8.06% | 7.5% to 9.0% |
| 8 | Appearance of Solution | Complies | The solution is clear and colourless or not more intensely coloured than reference solutions |
| 9 | Clarity of solution | Complies | The sample solution shows the same clarity as that of water or its opalescence should not more pronounced than standard suspension A |
| 10 | Colour of solution | Complies | The sample solution should not be more intensely colored than water or standard solution A, B, & C |
| 11 | Assay (anhydrous basis) | 99.8% | 99.5%-100.5% |
| 12 | Residue on ignition /Sulfated ash | 0.03% | NMT 0.1% |
| 13 | Sulphate (SO4) | Less than 0.015% | NMT 0.015% (NMT 150 ppm) |
| 14 | Oxalic acid | Less than 0.036% | NMT 0.036% (NMT 360 ppm) |
| 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. |
| 16 | Water | 8.06% | 7.5% to 9.0% |
| 17 | Total aerobic microbial count | Less than 1000 CFU/gm | NMT 1000 CFU/gm |
| 18 | Total Yeast and mold count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 19 | Bacterial endotoxin test | Less than 0.5 EU/mg | NMT 0.5 EU/mg |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, BP, 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.
