Macron™ 4874-26 Methylene Chloride, NF Grade, 200L Steel Drum
- 200L Steel Drum
- Manufacturer Part No: MK-4874-26
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Details
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets E.P. Chemical Specifications | |
Meets N.F. Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
NF - Assay | >= 99.0 % |
NF - Identification | Passes Test |
NF - Free Chlorine (Cl₂) | Passes Test |
NF - Heavy Metals (as Pb) | <= 1 ppm |
NF - Hydrogen Chloride (HCl) | <= 0.001 % |
NF - Methanol | <= 600 ppm |
NF - Nonvolatile Residue | <= 0.002 % |
NF - Specific Gravity at 25°C | 1.318 - 1.322 |
NF - Water | <= 0.02 % |
1,1-dichloroethene | |
EP - Appearance | Passes Test |
EP - Refractive Index | 1.423 - 1.425 Degree |
EP - Identification B | Passes Test |
EP - Identification C | Passes Test |
EP - Free Chlorine | Passes Test |
EP - Heavy Metals | <= 1 ppm |
EP - Acidity | Passes Test |
EP - Residue on Evaporation | <= 20 ppm |
EP - Relative Density @ 20° C | 1.320 - 1.332 |
EP - Water (KF) | <= 0.20 % |
EP - Ethanol, v/v | <= 2.0 % |
EP - 2-methylbut-2-ene, v/v | <= 300 ppm |
EP - Carbon tetrachloride, v/v | <= 10 ppm |
EP - Chloroform, v/v | <= 50 % |
EP - Total other impurities v/v | <= 0.1 % |
Residual Solvents - The Class 1 solvent 1,1-dichloroethene is likely to | |
be present. The concentration of 1,1-dichloroethene is quantified and | |
reported for each batch. Methanol and amylene (2-methyl-butylene) are | |
intentionally added as stabilizers. The concentration of methanol is | |
reported in the batch results. The concentration of amylene is less | |
than 40 ppm based on in-process controls. The Class 2 solvents | |
cyclohexane (less than 20 ppm) and 1,2-dichloroethene (less than 50 ppm) may be present due to their presence in the process raw material. They | |
are not selectively removed during processing. | |
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Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets E.P. Chemical Specifications | |
Meets N.F. Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
NF - Assay | >= 99.0 % |
NF - Identification | Passes Test |
NF - Free Chlorine (Cl₂) | Passes Test |
NF - Heavy Metals (as Pb) | <= 1 ppm |
NF - Hydrogen Chloride (HCl) | <= 0.001 % |
NF - Methanol | <= 600 ppm |
NF - Nonvolatile Residue | <= 0.002 % |
NF - Specific Gravity at 25°C | 1.318 - 1.322 |
NF - Water | <= 0.02 % |
1,1-dichloroethene | |
EP - Appearance | Passes Test |
EP - Refractive Index | 1.423 - 1.425 Degree |
EP - Identification B | Passes Test |
EP - Identification C | Passes Test |
EP - Free Chlorine | Passes Test |
EP - Heavy Metals | <= 1 ppm |
EP - Acidity | Passes Test |
EP - Residue on Evaporation | <= 20 ppm |
EP - Relative Density @ 20° C | 1.320 - 1.332 |
EP - Water (KF) | <= 0.20 % |
EP - Ethanol, v/v | <= 2.0 % |
EP - 2-methylbut-2-ene, v/v | <= 300 ppm |
EP - Carbon tetrachloride, v/v | <= 10 ppm |
EP - Chloroform, v/v | <= 50 % |
EP - Total other impurities v/v | <= 0.1 % |
Residual Solvents - The Class 1 solvent 1,1-dichloroethene is likely to | |
be present. The concentration of 1,1-dichloroethene is quantified and | |
reported for each batch. Methanol and amylene (2-methyl-butylene) are | |
intentionally added as stabilizers. The concentration of methanol is | |
reported in the batch results. The concentration of amylene is less | |
than 40 ppm based on in-process controls. The Class 2 solvents | |
cyclohexane (less than 20 ppm) and 1,2-dichloroethene (less than 50 ppm) may be present due to their presence in the process raw material. They | |
are not selectively removed during processing. | |