Product Specifications
TEST | MONOGRAPH | SPECIFICATION | |
Assay (by GC, corrected for water) | ACS | NLT 95.0% | |
Assay (by specific [email protected]°C) | USP | 94.9% – 96.0% (by volume) | |
Proof | 27CFR 30.23 | Lot Analysis | |
Identification Test A | USP | It meets the specifications of the test for Specific Gravity | |
Specific Gravity | USP | 0.812 – 0.816 @ 15.56°C | |
Identification Test B | USP | Conforms to IR Spectra | |
Solubility in Water | ACS+ | To Pass Test | |
Color of Solution | USP+ | The Sample solution has the appearance of water or is not more intensely colored than the standard solution | |
Clarity of Solution | USP+ | Sample solution A and Sample solution B show the same clarity as that of water, or their opalescence is not more pronounced than that of the Standard suspension A. | |
Color (APHA) | ACS | 10 max | |
Acidity or Alkalinity | USP+ | The solution is pink (30ppm, as acetic acid) | |
Titrable Acid | ACS+ | 0.0005 meq/g max. | |
Titrable Base | ACS+ | 0.0002 meq/g max. | |
Acetone/Isopropyl Alcohol | ACS | To Pass Test | |
Methanol | ACS | 0.1% max | |
Substances Darkened by Sulfuric Acid | ACS+ | To Pass Test | |
Substances Reducing Permanganate | ACS+ | To Pass Test | |
Limit of Nonvolatile Residue Residue after Evaporation | USP+ ACS+ | NMT 2.5 mg | |
ACS+ | NMT 0.001% | ||
UV Absorbance | USP | Examine between 235nm – 340nm | |
240nm | 0.40 max. | ||
250nm-260nm | 0.30 max. | ||
270nm-340nm | 0.10 max. | ||
The spectrum shows a steadily descending curve with no observable peaks or shoulders | |||
Organic Impurities | USP | Methanol | 200 ppm max. |
Acetaldehyde and Acetal | 10 ppm max. | ||
Benzene | 2ppm max. | ||
Sum of all other impurities | 300 ppm max. |