| Lactic acid USP/Ph.Eur/BP PARENTEX 500ML | |||
| P0808LM500 | 45832B226CY | ||
| USP/Ph.Eur/BP PARENTEX | 45832B2 | ||
| 79-33-4 | 115104 | ||
| C3H6O3 | March 2025 | ||
| 90.1 | February 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | Colorless, syrupy liquid. | Colorless or slightly yellow, syrupy liquid. | USP/Ph.Eur/BP |
| 2 | Solubility | Complies | Insoluble in chloroform;Miscible with water, Alcohol and with ethanol 96% | USP/Ph.Eur/BP |
| 3 | Identification (By chemical test) | Complies | The solution should be strongly acidic. | Ph.Eur/BP |
| 4 | Identification (by Relative density, 20°C) | 1.20 | 1.20 to 1.21 | Ph.Eur/BP |
| 5 | Identification (Lactate) | Complies | A blue color should produce. | USP |
| 6 | Appearance of solution | Complies | The solution should not be more intensely colored than reference solution Y6. | Ph.Eur/BP |
| 7 | Assay | 91.3% | 88.0% - 92.0% w/w | USP/Ph.Eur/BP |
| 8 | Sulphated ash / Residue on ignition | 0.02% | NMT 0.05% | USP/Ph.Eur/BP |
| 9 | Sugars and other reducing substances | Complies | No red or greenish precipitate should form. | Ph.Eur/BP |
| 10 | Calcium (Ca) | Less than 200 ppm | NMT 200 ppm | Ph.Eur/BP |
| 11 | Sulphate (SO4) | Less than 200 ppm | NMT 200 ppm | Ph.Eur/BP |
| 12 | Sulphate(SO4) | Complies | No turbidity should produce. | USP |
| 13 | Ether insoluble substances | Complies | The solution should not more opalescent than the solvent used for the test. | Ph.Eur/BP |
| 14 | Citric, oxalic and phosphoric acids | Complies | Any opalescence produced in the sample solution should not be more intense than that of reference solution. | Ph.Eur/BP |
| 15 | Limit of citric, oxalic, phosphoric or tartaric acid | Complies | No turbidity should produce. | USP |
| 16 | Chloride (Cl) | Complies | No opalescence should produce. | USP |
| 17 | Readily carbonizable substances | Complies | No dark color should develop at the interface of the two acid within 15 min. | USP |
| 18 | Sugars | Complies | No red precipitate should form. | USP/Ph.Eur/BP |
| 19 | Methanol(CH3OH) | 1.5 ppm | NMT 50 ppm | Ph.Eur/BP |
| 20 | Bacterial endotoxin test | Less than 5.0 EU/gm | NMT 5.0 EU/gm | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, BP 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.
