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E-mail:longmenapi@lmlactate.com
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Our pharmaceutical grade lactic acid is based on L-lactic acid, produced naturally from advanced bio-fermentation and stringent purification techniques. As a professional pharmaceutical grade medical lactic acid manufacturer, we have almost 60 years of history in producing injectable lactic acid.In china, more than 60% of pyrogen free, injectable lactic acid market is shared by us. Now we are thinking of expanding to abroad market. Please be assured to purchase medical grade Lactic acid at Luoyang Longmen. If you have any inquiries and problems, please feel free to send emails to us via longmenapi@lmlactate.com. We will reply you within 1 working day.
Lactic Acid
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Lactic acid USP43
| Items | Specification | |
| Appearance | Colorless or slightly yellow, syrupy liquid. Miscible with water and ethanol(96 per cent ) | |
| Identification | Gives the reaction of lactates. | |
| Tests | Chloride | No opalescence is produced immediately |
| Sulfate | No turbidity is produced | |
| Residue on ignition | Maximum 0.05% | |
| Limit of citric, oxalic, phosphoric or tartaric acid | No turbidity is produced | |
| Readily carbonizable substance | No dark color develops at the interface of the two acid within 15 min. | |
| Sugars | No red precipitate is formed | |
| Bacterial endotoxins | Maximum 5IU/g | |
Microbial limits |
Aerobic bacteria counts: ≦102 cfu/ml | |
| Molds and yeasts counts:≦102 cfu/ml | ||
| Escherichia Coli counts:Negative | ||
| Assay | 88.0 per cent m/m to 92.0 per cent m/m of C3H6O3. | |
Lactic acid EP 10.0
| Items | Specification EP 10.0 | ||
| Characters | Appearance | Colourless or slightly yellow,syrup liquid. | |
| Solubility | Miscible with water and with ethanol(96 per cent) | ||
| Identification | Relative density:1.20~1.21 | ||
| Solution is strongly acidic | |||
| Gives the reaction of lactates. | |||
Tests |
Appearance | Not more intensely colored than reference solution Y6 | |
| Ether insoluble substance | Not more opalescent than the solvent used for the test | ||
| Sugars and other reducing substance | No red or greenish precipitate is formed | ||
| Methanol | Maximum 50 ppm | ||
| Citric, oxalie and phosphorie acids | Not more intense than that in a mixture of 1mL of water R and 5 mL solution S | ||
| Calcium | Maximum 200ppm | ||
| Sulfates | Maximum 200ppm | ||
| Barium | Not more intense than that of standard solution | ||
| Heavy metal | Maximum 10 ppm | ||
| Sulfated ash | Maximum 0.1 percent | ||
| Bacterial endotoxins | 5 IU/g | ||
| Microbial limits | Aerobic bacteria counts: ≦102 cfu/ml | ||
| Molds and yeasts counts:≦102 cfu/ml | |||
| Escherichia Coli counts:Negative | |||
| Assay | 88.0 per cent m/m to 92.0 per cent m/m of C3H6O3. | ||
Lactic acid BP2020
| Items | Specification BP 2020 | ||
| Characters | Appearance | A clear colorless to almost colorless, viscous liquid. | |
| Solubility | Miscible with water and with ethanol(96 per cent). | ||
| Identification | Relative density:1.20~1.21 | ||
| Solution is strongly acidic. | |||
| Gives the reaction of lactates. | |||
Tests |
Appearance | Not more intensely coloured than reference solution Y6. | |
| Ether insoluble substance | Not more opalescent than the solvent used for the test. | ||
| Sugars and other reducing substance | No red or greenish precipitate is formed. | ||
| Methanol | Maximum 50 ppm | ||
| Citric, oxalie and phosphorie acids | Not more intense than that in a mixture of 1mL of water R and 5 mL solution S | ||
| Calcium | Maximum 200ppm | ||
| Sulfates | Maximum 200ppm | ||
| Barium | Not more intense than that of standard solution | ||
| Heavy metal | Maximum 10 ppm | ||
| Sulfated ash | Maximum 0.1 percent | ||
| Bacterial endotoxins | 5 IU/g | ||
| Microbial limits | Aerobic bacteria counts: ≦102 cfu/ml | ||
| Molds and yeasts counts:≦102 cfu/ml | |||
| Escherichia Coli counts:Negative | |||
| Assay | 88.0 per cent m/m to 92.0 per cent m/m of C3H6O3. | ||