| Lactic acid IP/BP PARENTEX 2KG | |||
| P2808LR200 | 45163B927LX | ||
| IP/BP PARENTEX | 45163B9 | ||
| 79-33-4 | 111399 | ||
| C3H6O3 | December 2024 | ||
| 90.1 | November 2027 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | A colourless, viscous liquid; almost odourless; hygroscopic. | A colourless or slightly yellow, syrupy liquid , viscous liquid; almost odourless; hygroscopic. | IP/BP |
| 2 | Solubility | Complies | Miscible in all proportion with water, with ethanol (95%) ,with Ethanol (96%) and with ether. | IP/BP |
| 3 | Identification A (By Chemical test) | Complies | Aldehyde should evolve. | IP |
| 4 | Identification B (By Relative density, 20°C) | 1.204 | 1.20-1.21 | BP |
| 5 | Identification C (By Chemical test) | Complies | A dark green ring appears at the interface of the two liquids. | IP/BP |
| 6 | Identification D (By Chemical test) | Complies | Solution should be strongly acidic. | IP/BP |
| 7 | Appearance of Solution | Complies | The substance is not more intensely coloured than reference solution YS6. | IP/BP |
| 8 | Arsenic (As) | Less than 1ppm | NMT 1ppm | IP |
| 9 | Heavy metals | Less than 10ppm | NMT 10ppm | IP |
| 10 | Citric, oxalic and phosphoric acids | Complies | Any opalescence in the solution is not more intense than that in a mixture of 5 mL of the test solution and 1 mL of water. | IP/BP |
| 11 | Ether insoluble substances | Complies | The solution is not more opalescent than the solvent used for the test. | IP/BP |
| 12 | Volatile fatty acids | Complies | No unpleasant odour resembling that of lower fatty acids is recognizable immediately after opening the flask. | IP |
| 13 | Methanol and methyl esters | Complies | Any color in the solution is not more intense than that of 1 mL of reference solution. | IP |
| 14 | Reducing sugars | Complies | No red or greenish precipitate should produce. | IP/BP |
| 15 | Sulphated ash | 0.014% | NMT 0.1% | IP/BP |
| 16 | Calcium (Ca) | Less than 200ppm | NMT 200ppm | BP |
| 17 | Sulphate | Less than 200ppm | NMT 200ppm | BP |
| 18 | Methanol(CH3OH) | Less than 50ppm | NMT 50ppm | BP |
| 19 | Assay | 90.2% | 88.0% - 92.0% w/w | IP/BP |
| 20 | Bacterial endotoxins | 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 IP, 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.
