Pharmaceutical Effluent Guidelines (40 CFR 439)
The U.S. Environmental Protection Agency (EPA) has promulgated effluent limitation guidelines and standards by contributing to 40 CFR part 439.These important laws and regulations are for the Pharmaceutical Manufacturing Industry to control the discharge of pollutants into the surface waters of the United States. The following test methods support the final rule:
- EPA Method 1666A – Volatile Organic Compounds Specific to the Pharmaceutical Manufacturing Industry by Isotope Dilution GC/MS
- EPA Method 1671A – Volatile Organic Compounds Specific to the Pharmaceutical Manufacturing Industry by GC/FID
- EPA Method 524 – Volatile Organic Compounds required for a select set of compounds listed in the Pharmaceutical Effluent Guidelines (40 CFR 439). GC/MS
(See list of analytes listed at bottom of page)
We have both the ability and experience to meet all of your Pharmaceutical Manufacturing Industry (PMI) analytical needs. We provide the Pharmaceutical industry with professional project managers, comprehensive data review and excellent turnaround times.
Teklab can set up a specific program for each facility based on your POTW or NPDES permit. And our Laboratory Information System (LIMs) can notify you each time a regulatory limit is exceeded; allowing prompt action to correct any problems.
There are four subcategories in the EAP regulations which are based on the type of operation performed at the facility.
- Subcategory A – Fermentation production
- Subcategory B – Extraction Products
- Subcategory C – Chemical Synthesis Products
- Subcategory D – Mixing/Compounding and Formulation
Contaminants and Methods for the Analysis of Wastewater in the Pharmaceutical Manufacturing Industry (PMI)
| Pollutant | CAS # | EPA Analytical Method |
| acetone | 67-64-1 | 524.2 |
| acetonitrile | 75-05-8 | 1671 |
| n-amyl acetate | 628-63-7 | 1666 |
| n-amyl alcohol | 71-41-0 | 1666 |
| benzene | 71-43-2 | 524.2 |
| n-butyl acetate | 123-86-4 | 1666 |
| tert-butyl alcohol | 75-65-0 | 1666 |
| chlorobenzene | 108-90-7 | 524.2 |
| Chloroform | 67-66-3 | 524.2 |
| o-dichlorobenzene | 95-50-1 | 524.2 |
| 1,2-dichloroethane | 107-06-2 | 524.2 |
| diethylamine | 109-89-7 | 1671 |
| diethyl sulfoxide (DMSO) | 67-68-5 | 1671 |
| ethanol | 64-17-5 | 1671 |
| ethyl acetate | 141-78-6 | 1666 |
| n-heptane | 142-82-5 | 1666 |
| n-hexane | 110-54-3 | 1666 |
| isobutyraldehyde | 78-84-2 | 1666 |
| isopropanol | 67-56-1 | 1666 |
| isopropyl acetate | 108-21-4 | 1666 |
| isopropyl ether | 108-20-3 | 1666 |
| Methanol | 67-56-1 | 1671 |
| methyl cellosolve | 109-86-4 | 1671 |
| methylene chloride | 75-09-2 | 524.2 |
| methyl formate | 107-31-3 | 1666 |
| 4-methyl-2-pentanone (MIBK) | 108-10-1 | 1666 |
| Phenol | 108-95-2 | 624 |
| n-propanol | 71-23-8 | 1671 |
| Tetrahydrofuran (THF) | 109-99-9 | 1666 |
| Toluene | 108-88-3 | 524.2 |
| triethylamine | 121-44-8 | 1671 |
| Xylenes (total) | 1666 |
Contaminants and Methods for the Analysis of Wastewater in the Pharmaceutical Manufacturing Industry (PMI) – Limits
| Pollutant | Limits 439.14 | Limits 439.17 | EPA Analytical Method |
| acetone | 0.2 | 8.2 | 524.2 |
| acetonitrile | 10.2 | 1671 | |
| n-amyl acetate | 0.5 | 8.2 | 1666 |
| n-amyl alcohol | 4.1 | 1666 | |
| benzene | 0.02 | 0.7 | 524.2 |
| n-butyl acetate | 0.5 | 8.2 | 1666 |
| tert-butyl alcohol | 1666 | ||
| chlorobenzene | 0.06 | 0.7 | 524.2 |
| Chloroform | 0.13 | 0.03 | 524.2 |
| o-dichlorobenzene (1,2 dichlorobenzene) | 0.06 | 8.2 | 524.2 |
| 1,2-dichloroethane | 0.1 | 8.2 | 524.2 |
| diethylamine | 102.0 | 100 | 1671 |
| diethyl sulfoxide (DMSO) | 37.5 | 1671 | |
| ethanol | 4.1 | 1671 | |
| ethyl acetate | 0.5 | 8.2 | 1666 |
| n-heptane | 0.02 | 0.7 | 1666 |
| n-hexane | 0.02 | 0.7 | 1666 |
| isobutyraldehyde | 0.5 | 8.2 | 1666 |
| isopropanol (2-Propanol) | 1.6 | 1666 | |
| isopropyl acetate | 0.5 | 8.2 | 1666 |
| isopropyl ether (Diisopropyl ether) | 2.6 | 8.2 | 1666 |
| Methanol | 4.1 | 1671 | |
| methyl cellosolve (2-Methoxyethanol) | 40.6 | 59.7 | 1671 |
| methylene chloride | 0.3 | 0.7 | 524.2 |
| methyl formate | 0.5 | 8.2 | 1666 |
| 4-methyl-2-pentanone (MIBK) | 0.2 | 8.2 | 1666 |
| Phenol | 0.02 | 624 | |
| n-propanol | 1671 | ||
| Tetrahydrofuran (THF) | 2.6 | 3.4 | 1666 |
| Toluene | 0.02 | 0.0 | 524.2 |
| triethylamine | 102.0 | 100 | 1671 |
| Xylenes (total) | 0.01 | 0.7 | 1666 |
