Pharmaceutical Manufacturing: Point Source Category / Wastewater Analysis

Pharmaceutical Effluent Guidelines (40 CFR 439)

The U.S. Environmental Protection Agency (EPA) has promulgated effluent limitation guidelines and standards at 40 CFR part 439.These rules 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)

TEKLAB, Inc. has 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
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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 8.21666
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