| Lactic acid USP/Ph.Eur/BP PARENTEX PLUS 2LT | |||
| I0808LC200 | 43029B128BX | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 43029B1 | ||
| 79-33-4 | 102143 | ||
| C3H6O3 | February 2024 | ||
| 90.1 | January 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Colorless syrupy liquid. | Colorless or slightly yellow, syrupy liquid |
| 2 | Solubility | Complies | Insoluble in chloroform; Miscible with water, Alcohol and with ethanol (96%) |
| 3 | Identification (By chemical test) | Complies | The solution should be strong acidic. |
| 4 | Identification (by Relative density, 20°C) | 1.21 | 1.20 to 1.21 |
| 5 | Identification (Lactate) | Complies | A blue color should produce |
| 6 | Appearance of solution | Complies | The solution should not be more intensely coloured than reference solution Y6 |
| 7 | Assay | 89.4% | 88.0% - 92.0% w/w |
| 8 | Sulphated ash / Residue on ignition | 0.006% | NMT 0.05% |
| 9 | Sugars and other reducing substances | Complies | No red or greenish precipitation should form. |
| 10 | Calcium (Ca) | Less than 200ppm | NMT 200 ppm |
| 11 | Sulphate (SO4) | Less than 200ppm | NMT 200 ppm |
| 12 | Ether insoluble substances | Complies | The solution should not more opalescent than the solvent used for the test. |
| 13 | Citric, oxalic and phosphoric acids | Complies | Any opalescence produced in the sample solution should not be more intence than that of reference solution |
| 14 | Limit of citric, oxalic, phosphoric or tartaric acid | Complies | No turbidity should produce |
| 15 | Chloride (Cl) | Complies | No opalescence should produce |
| 16 | Readily carbonizable substances | Complies | No dark color should develop at the interface of the two acid within 15 min |
| 17 | Sugars | Complies | No red precipitate should form |
| 18 | Methanol(CH3OH) | Not detected | NMT 50 ppm |
| 19 | Bacterial endotoxin test | Less than 3.0 EU/ml | NMT 3.0 EU/ml |
| 20 | Total Yeast and mold count | Less than 100 CFU/ml | NMT 100 CFU/ml |
| 21 | Total aerobic microbial count | Less than 100 CFU/ml | NMT100 CFU/ml |
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.
