Acetone FCC, Multi-Compendial, Macron Fine Chemicals™
Supplier: Avantor Performance Materials
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Danger
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Synonyms:
2-Propanone, DMK, Propanone, Dimethyl ketone
MACR4952-06EA
11420
INR
MACR4952-06
MACR4952-08
Acetone FCC, Multi-Compendial, Macron Fine Chemicals™
Acetone
Formula:
CH₃COCH₃ MW: 58,08 g/mol Boiling Pt: 56,2 °C (1013 hPa) Melting Pt: –95,4 °C Density: 0,792 g/cm³ (20 °C) Flash Pt: <–20 °C (closed cup) Storage Temperature: Ambient |
MDL Number:
MFCD00008765 CAS Number: 67-64-1 EINECS: 200-662-2 UN: 1090 ADR: 3,II REACH: 01-2119471330-49 Merck Index: 13,00067 |
Specification Test Results
Food GMP Manufactured Product | |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets F.C.C. Requirements | |
Meets J.P. Chemical Specifications | |
Store in airtight container. | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Food Chemical | |
Bulk Pharmaceutical Chemical | |
FCC - Assay (C₆H₉N₃O₂·HCl) (dried basis) | 98.5 - 101.5 % |
FCC - Identification | Passes Test |
FCC - Lead (Pb) | ≤ 5 mg/kg |
FCC - Loss on Drying at 105°C | ≤ 0.3 % |
FCC - Residue after Ignition | ≤ 0.10 % |
FCC - Specific Rotation [Å]²º^D (+) | 8.5 - 10.5 Degree |
EP/BP - Assay (C₆H₉N₃O₂·HCl) (dried basis) | 98.5 - 101.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Identification C | Passes Test |
EP/BP - Identification F | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - pH | 3.0 - 5.0 |
EP/BP - Specific Rotation [Å]²º^D (+) | 9.2 - 10.6 Degree |
EP/BP-Ninhydrin-Positive Substances-Each | ≤ 0.2 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤ 0.5 % |
EP/BP - Sulfate (SO₄) | ≤ 300 ppm |
EP/BP - Ammonium (NH₄) | ≤ 0.02 % |
EP/BP - Iron (Fe) | ≤ 10 ppm |
EP/BP - Loss on Drying at 150°C | 7.0 - 10.0 % |
EP/BP - Ash (sulfated) | ≤ 0.1 % |
JP - Identification | Passes Test |
JP - Optical Rotation (+) | 9.2 - 10.6 |
JP - pH | 3.5 - 4.5 |
JP - Clarity and Color of Solution | Passes Test |
JP - Sulfate (SO₄) | ≤ 0.028 % |
JP - Ammonium (NH₄) | ≤ 0.02 % |
JP - Heavy Metals (as Pb) | ≤ 10 ppm |
JP - Iron (Fe) | ≤ 10 ppm |
JP - Related Substances | Passes Test |
JP - Water | 7.2 - 10.0 % |
JP - Residue on Ignition | ≤ 0.10 % |
JP - Assay (anhydrous basis) | 99.0 - 101.0 % |
Microbial Testing – Total Aerobic Microbial Count (USP) | ≤ 10 cfu/g |
Microbial Testing – Total Yeast and Mold Count (USP) | ≤ 10 cfu/g |
Endotoxin Concentration (EU/g) | ≤ 10 |
Trace Impurities - Cadmium (Cd) | ≤ 200 ppb |
Trace Impurities - Lead (Pb) | ≤ 500 ppb |
Trace Impurities - Arsenic (As) | ≤ 1500 ppb |
Trace Impurities - Mercury (Hg) | ≤ 300 ppb |
Trace Impurities - Cobalt (Co) | ≤ 500 ppb |
Trace Impurities - Vanadium (V) | ≤ 1000 ppb |
Trace Impurities - Nickel (Ni) | ≤ 2000 ppb |
Trace Impurities - Thallium (Tl) | ≤ 800 ppb |
Trace Impurities - Gold (Au) | ≤ 10000 ppb |
Trace Impurities - Palladium (Pd) | ≤ 1000 ppb |
Trace Impurities - Iridium (Ir) | ≤ 1000 ppb |
Trace Impurities - Osmium (Os) | ≤ 1000 ppb |
Trace Impurities - Rhodium (Rh) | ≤ 1000 ppb |
Trace Impurities - Ruthenium (Ru) | ≤ 1000 ppb |
Trace Impurities - Selenium (Se) | ≤ 8000 ppb |
Trace Impurities - Silver (Ag) | ≤ 1000 ppb |
Trace Impurities - Platinum (Pt) | ≤ 1000 ppb |
Trace Impurities - Lithium (Li) | ≤ 25000 ppb |
Trace Impurities - Antimony (Sb) | ≤ 9000 ppb |
Trace Impurities - Barium (Ba) | ≤ 70000 ppb |
Trace Impurities - Molybdenum (Mo) | ≤ 150000 ppb |
Trace Impurities - Copper (Cu) | ≤ 30000 ppb |
Trace Impurities - Tin (Sn) | ≤ 60000 ppb |
Trace Impurities - Chromium (Cr) | ≤ 110000 ppb |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
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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