| Citric acid monohydrate CPH8 PARENTEX PLUS 5KG | |||
| I5490SR500 | 44266H529HX | ||
| CPH8 PARENTEX PLUS | 44266H5 | ||
| 5949-29-1 | 106820 | ||
| C6H8O7.H2O | August 2024 | ||
| 210.14 | July 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Colourless translucent crystals. | Colourless, translucent crystals; white or almost white granular to fine crystalline powder. Efflorescent in warm, in dry air.(Note: The product may cause lumps or hardening over the storage). |
| 2 | Solubility | Complies | Very soluble in water, freely soluble in alcohol, very slightly soluble in ether |
| 3 | Identification by Chemical test | 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 standard |
| 5 | Identification (By chemical test 1) | Complies | A red colour should develop. |
| 6 | Identification (By chemical test 2) | Complies | A white precipitate should formed |
| 7 | Identification (By chemical test 3) | Complies | It gives reaction A of citrates |
| 8 | Identification (By Water) | 8.44% | 7.5% to 9.0% |
| 9 | Identification | Complies | Yields the reactions characteristic of citrates. |
| 10 | Appearance of solution | Complies | The solution is clear and colourless or not more intensely coloured than reference solution YS7, BYS7 or GYS7 |
| 11 | 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 |
| 12 | Colour of solution | Complies | The sample solution is not more intensely colored than water or standard solutions A, B, and C. |
| 13 | Assay (Anhydrous basis) | 100.35% | 99.5% - 100.5% |
| 14 | Residue on ignition /Sulfated ash | 0.058% | NMT 0.1% |
| 15 | Sulfate | Less than 150ppm | NMT 150ppm |
| 16 | Limit of oxalic acid | Less than 360ppm | NMT 360ppm |
| 17 | Readily carbonizable substances | Complies | The color of the acid is not darker than that of a similar volume of reference solution. |
| 18 | Chloride (Cl) | Less than 0.0005% | NMT 0.0005% |
| 19 | Oxalate | Complies | No turbidity should appear. |
| 20 | Calcium | Less than 200 ppm | NMT 200ppm |
| 21 | Iron | Less than 0.001% | NMT 0.001% |
| 22 | Arsenic | Less than 0.0001% | NMT 0.0001% |
| 23 | Barium | Complies | Any opalescence produced should not more intense than that of mixture of 5ml of solution A and 5ml of distilled water |
| 24 | Water | 8.44% | 7.5% to 9.0% |
| 25 | Oxalic acid | Complies | Any pink colour produced is not more intense than that produced by carrying out the test using 0.2mg of oxalic acid dissolved in 4ml of water. |
| 26 | Heavy metals | Less than 10 ppm | NMT 10 ppm |
| 27 | Total aerobic microbial count | Less than 1000 CFU/gm | NMT 1000 CFU/gm |
| 28 | Total Yeast and mold count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 29 | Escherichia coli | Absent/gm | Should be absent /gm |
| 30 | Pseud. aeruginosa | Absent/gm | Should be absent /gm |
| 31 | Staphylococcus aureus | Absent/gm | Should be absent /gm |
| 32 | Salmonella | Absent/25gm | Should be absent /25gm |
| 33 | Bile-tolerant bacteria | Absent/gm | NMT 100 CFU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur,CP, IP 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.
