Milchsäure 88,0-92,0%, Multikompendial, J.T.Baker®
Lieferant: Avantor
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Gefahr
|
Synonyms:
DL-Milchsäure
Veränderungsmanagement-Kategorie= R
0200-01EA
183
CHF
0200-01
0200-03
0200-07
Milchsäure 88,0-92,0%, Multikompendial, J.T.Baker®
Milchsäure
Zertifizierungen: GMP manufactured product, meets USP requirement and EP chemical specification.
Bitte beachten For Manufacturing, processing or repackaging
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Formel:
H₃CCH(OH)COOH MW: 90,08 g/mol Dichte: ∼1,20 g/ml (20 °C) |
MDL Number:
MFCD00004520 CAS-Nummer: 50-21-5 UN: 3265 ADR: 8,II |
Spezifikation Testergebnisse
| Meets E.P. Chemical Specifications | |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| 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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