Lactic acid 88.0-92.0%, Multi-Compendial, J.T.Baker®
Supplier: Avantor
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Danger
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Synonyms:
DL-Lactic acid, 2-Hydroxypropionic acid, 2-Hydroxypropanoic acid
Management of Change (MOC) category = R
BAKR0200-01EA
210
SGD
BAKR0200-01
BAKR0200-03
BAKR0200-07
Lactic acid 88.0-92.0%, Multi-Compendial, J.T.Baker®
Lactic acid
Certifications: GMP manufactured product, meets USP requirement and EP chemical specification.
Caution: For Manufacturing, processing or repackaging
Formula:
H₃CCH(OH)COOH MW: 90,08 g/mol Density: ∼1,20 g/ml (20 °C) |
MDL Number:
MFCD00004520 CAS Number: 50-21-5 UN: 3265 ADR: 8,II |
Specification Test Results
Meets E.P. Chemical Specifications | 88.0 - 92.0% |
GMP Manufactured Product | Passes Test |
Meets U.S.P Requirements | Passes Test |
CAUTION: For Manufacturing, processing or repackaging | Passes Test |
Bulk Pharmaceutical Chemical | Passes Test |
USP - Assay (CH₃CHOHCOOH) | 88.0 - 92.0 % |
USP - Chloride (Cl) | Passes Test |
USP - Citric, Oxalic, Phosphoric, or Tartaric Acids | Passes Test |
USP - Identification | Passes Test |
USP - Readily Carbonizable Substances | Passes Test |
USP - Residue on Ignition | ≤ 0.05 % |
USP - Sugars | Passes Test |
USP - Sulfate (SO₄) | Passes Test |
EP - Assay (CH₃CHOHCOOH) | 88.0 - 92.0 % |
EP - Appearance | Passes Test |
EP - (S)-enantiomer | ≥ 95.0 % |
EP - Calcium (Ca) | ≤ 200 ppm |
EP - Citric, Oxalic, and Phosphoric Acids | Passes Test |
EP - Endotoxin Concentration, <5 IU/g | Passes Test |
EP - Ether-Insoluble Substances | Passes Test |
EP - Identification A | Passes Test |
EP - Identification B | Passes Test |
EP - Identification C | Passes Test |
EP - Methanol (by GC) | ≤ 50 ppm |
EP - Sugars and Other Reducing Substances | Passes Test |
EP - Sulfate (SO₄) | ≤ 200 ppm |
EP - Sulfated Ash | ≤ 0.1 % |
JP - Assay (CH₃CHOHCOOH) | 85.0 - 92.0 % |
JP - Chloride (Cl) | ≤ 0.036 % |
JP - Citric, Oxalic, Phosphoric, or Tartaric Acids | Passes Test |
JP - Cyanide (CN) | Passes Test |
JP - Glycerin and Mannitol | Passes Test |
JP - Heavy Metals (as Pb) | ≤ 10 ppm |
JP - Identification | Passes Test |
JP - Iron (Fe) | ≤ 5 ppm |
JP - Readily Carbonizable Substances | Passes Test |
JP - Residue on Ignition | ≤ 0.10 % |
JP - Sugars | Passes Test |
JP - Sulfate (SO₄) | ≤ 0.010 % |
JP - Volatile Fatty Acids | Passes Test |
JP - Optical Rotation | -52 - -46 Degree |
This product is pyrogen free. | |
Only Class 3 Solvents are likely to be present. Residual concentration | |
of all Class 3 Solvents is <0.5%. | |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
impurities for this product is available on the associated Product | |
Regulatory Data Sheet and elemental impurity profile report. |
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