EPA 1671 PMI
This method is for surveying and monitoring under the Clean Water Act. The method is used to
determine certain non-purgeable volatile organic pollutants specific to the pharmaceutical
manufacturing industry (PMI) that are amenable to direct aqueous injection gas chromatography
(GC) and detection by a flame ionization detector (FID).
Teklab is a NELAC accredited environmental testing laboratory that provides specialty analysis such as those required for pharmaceutical effluent. EPA 1671 includes the following compounds, as well as others;
- Dimethyl Acetamide
- 2-Methoxyethanol
- Acetonitrile
- Diethylamine
- Dimethyl Sulfoxide
- Dimethylamine
- Ethanol
- Ethylene glycol
- Methanol
- n-Propanol
- Triethylamine
Our semi-volatile organic testing lab routinely performs specialty analysis like EPA 1671 PMI for other environmental testing labs. Teklab also analyses PMI compounds by Methods EPA 1666 and EPA524.2. The detection limits of Method 1671 are usually dependent on the level of interferences rather than instrumental limitations. The toxicity or carcinogenicity of each analyte, compound, or reagent used in this method has not been precisely determined; however, each chemical compound should be treated as a potential health hazard. Exposure to these compounds should be reduced to the lowest possible level.
In recognition of advances that are occurring in analytical technology, and to allow the analyst to
overcome sample matrix interferences, the analyst is permitted certain options to improve
separations or lower the costs of measurements. These options include alternative concentration and
cleanup procedures, and changes in columns and detectors. Alternative techniques, such as the
substitution of spectroscopy or immunoassay, and changes that degrade method performance are not
allowed. If an analytical technique other than the techniques specified in this method is used, that
technique must have a specificity equal to or better than the specificity of the techniques in this
method for the analytes of interest.
Links to Helpful Documents:
- Method 1671, Revision A: Volatile Organic Compounds Specific to the Pharmaceutical Manufacturing Industry
- Permit Guidance Document: Pharmaceutical Manufacturing Point Source Category (40CFR Part439)
- EPA Guidelines: Analytical Method Guidance for the Pharmaceutical Manufacturing Point Source Category
- Federal Register 40CFR Parts 136 and 439. Pharmaceutical Manufacturing Category. Effluent Limitations Guidelines, Pretreatment Standards and New Source Performance Standards
