Page 1 of 3

PRODUCT SPECIFICATIONS SHEET

WORLD/GMP GRADE
ETHYL ALCOHOL 95%
Meets ACS/USP/EP/BP/JP/FCC GRADE Monographs
With USP<232>, EMA and ICH Q3D Test Results
Grain Derived Ethanol
Catalog Number: 111GMP190-Size Code*

*Individual package sizes have unique size codes

Manufactured in compliance with cGMP
MONO- TYPICAL
TEST SPECIFICATION
GRAPH RESULT
ACS NLT 95.0%
Assay (by GC, corrected for water) 95.01%
o 1
Assay (by specific [email protected] C) USP 94.9% - 96.0% (by volume)
95.01%
Assay (by specific gravity@25oC) FCC NLT 94.9%
27CFR
Proof Lot Analysis 190.0
30.23
Identification A - Specific Gravity USP1 0.812 - 0.816 @ 15.56°C
0.8158
Specific Gravity JP d 15/15 0.809 – 0.816 0.816
Specific Gravity FCC Not more than 0.8096 @ 25.0°C 0.8092
Identification Test B USP/EP/BP Conforms to IR Spectra Pass
Identification 1 JP Conforms to IR Spectra Pass
An intense blue color appears on the paper and becomes
Identification Test C EP/BP Pass
paler after 10-15 minutes
Identification Test D EP/BP A yellow precipitate is formed within 30minutes Pass
Solubility in Water ACS To Pass Test
Solubility in Water FCC No haze or turbidity develops Pass
Solubility EP/BP Miscible with water and with methylene chloride
The Sample solution has the appearance of water or is not
Color of Solution USP Pass
more intensely colored than the standard solution
Sample Solutions show the same clarity as that of water,
Clarity of Solution Pass
USP or their opalescence is not more pronounced than that of
Purity 1 – Clarity and Color of
JP Reference.
Solution Pass
The mixture remains clear
Clear and Colorless dilution remains clear when compared
Appearance EP/BP Pass
with water
Acidity or Alkalinity USP/EP/BP The solution is pink (30ppm, as acetic acid) Pass
Purity 2 – Acidity or alkalinity JP A light red color develops Pass
Acidity (as acetic acid) FCC <0.003% Pass
Alkalinity (as NH3) FCC <3 mg/kg Pass
Titrable Acid ACS 0.0005 meq/g max. <0.0003 meq/g
Titrable Base ACS 0.0002 meq/g <0.0001 meq/g
Fusel Oil FCC To Pass Test Pass
Acetone/Isopropyl Alcohol ACS To Pass Test Pass
Ketones, Isopropyl Alcohol FCC To Pass Test Pass

Form: Ethanol, Pure, 190, GMP, Rev. 2.0, 06/16, KAD

Disclaimer: For Industrial/Lab use only. Not intended as a Drug Substance, Medical Device or Disinfectant. Appropriate/legal use of this
product is the responsibility of the user. (Rev. # disclaimer only: Rev 3.6, 07/15, PD)
 Page 2 of 3
MONO- TYPICAL
TEST SPECIFICATION
GRAPH RESULT
Methanol ACS 0.1% max <0.1%
FCC To Pass Test Pass
Lead FCC NMT 0.5 mg/kg Pass
Substances Darkened by Sulfuric Acid ACS/FCC To Pass Test Pass
Substances Reducing Permanganate ACS/FCC To Pass Test Pass
Limit of Nonvolatile Residue USP NMT 2.5 mg 0.5mg
Nonvolatile Residue FCC NMT 0.003% <0.001%
Residue after Evaporation ACS 0.001% , max 0.0006%
Residue on Evaporation EP/BP 25 ppm, max <10 ppm
Purity 5 - Residue on Evaporation JP NMT 2.5 mg 0.5mg
Examine between 235nm – 340nm
240nm 0.40 max. 0.24
UV Absorbance
USP/EP/BP 250nm-260nm 0.30 max. 0.09
Purity 4 - Other Impurities
JP 270nm-340nm 0.10 max. 0.02
(absorbance)
The spectrum shows a steadily descending curve with no Pass
observable peaks or shoulders.
Methanol 200 ppm <5 ppm
Volatile Impurities USP/EP/BP Sum of Acetal and Acetaldehyde 10ppm max <1 ppm
Purity 3 – Volatile Impurities JP Benzene 2ppm max. <1 ppm
Total of all other impurities 300ppm max. <20 ppm
1
No EP/BP/JP specifications for this assay

Form: Ethanol, Pure, 190, GMP, Rev. 2.0, 06/16, KAD

Disclaimer: For Industrial/Lab use only. Not intended as a Drug Substance, Medical Device or Disinfectant. Appropriate/legal use of this
product is the responsibility of the user. (Rev. # disclaimer only: Rev 3.6, 07/15, PD)
 Page 3 of 3

Permitted Concentrations of Elemental Impurities Following Option 1 Guideline in drug

products, drug substances and excipients1
Reported in µg/g (ppm)
TYPICALR
Oral Concentration Parenteral Inhalation ESULT
Element Class
μg/g Concentration μg/g Concentration μg/g (in µg/g)
(ppm)
Cd (Cadmium) 1 0.5 0.2 0.2 0.00
Pb (Lead) 1 0.5 0.5 0.5 0.00
As (Arsenic) 1 1.5 1.5 0.2 0.00
Hg (Mercury) 1 3 0.3 0.1 0.00
Co (Cobalt) 2A 5 0.5 0.3 0.00
V (Vanadium) 2A 10 1 0.1 0.00
Ni (Nickel) 2A 20 2 0.5 0.00
Tl (Thallium) 2B 0.8 0.8 0.8 0.00
Au (Gold) 2B 10 10 0.1 0.00
Pd (Palladium) 2B 10 1 0.1 0.00
Ir (Iridium) 2B 10 1 0.1 0.00
Os (Osmium) 2B 10 1 0.1 0.00
Rh (Rhodium) 2B 10 1 0.1 0.00
Ru (Ruthenium) 2B 10 1 0.1 0.00
Se (Selenium) 2B 15 8 13 0.00
Ag (Silver) 2B 15 1 0.7 0.00
Pt (Platinum) 2B 10 1 0.1 0.00
Li (Lithium) 3 55 25 2.5 0.00
Sb (Antimony) 3 120 9 2 0.00
Ba (Barium) 3 140 70 30 0.00
Mo (Molybdenum) 3 300 150 1 0.00
Cu (Copper) 3 300 30 3 0.00
Sn (Tin) 3 600 60 6 0.00
Cr (Chromium) 3 1100 110 0.3 0.00
1Includes all requirements for ICH Q3D-Step 4 version, EMA (EP) 5.2 and USP <232> and <233> General Chapters.

Form: Ethanol, Pure, 190, GMP, Rev. 2.0, 06/16, KAD

Disclaimer: For Industrial/Lab use only. Not intended as a Drug Substance, Medical Device or Disinfectant. Appropriate/legal use of this
product is the responsibility of the user. (Rev. # disclaimer only: Rev 3.6, 07/15, PD)
 Page 1 of 3
PRODUCT SPECIFICATIONS SHEET
WORLD/GMP GRADE
ETHYL ALCOHOL
Absolute, Dehydrated, Anhydrous, 200 Proof, Pure Ethanol
Meets ACS/USP/EP/BP/JP/FCC GRADE Monographs
With USP<232>, EMA and ICH Q3D Test Results
Grain Derived Ethanol
Catalog Number: 111WORLD200-Size Code*
*Individual package sizes have unique size codes
Manufactured in compliance with cGMP
MONO- TYPICAL
TEST SPECIFICATION
GRAPH RESULT
Internal NLT 99.9%
Assay (by GC, corrected for water) ACS NLT 99.5% 99.98%

Assay (by specific [email protected]) Internal NLT 99.9%

Assay (by specific [email protected]) USP NLT 99.5% 99.99%
Assay (by relative density @20oC) EP/BP NLT 99.5%
Assay (by specific gravity@15oC) JP NLT 99.5%
Assay (by specific gravity@25oC) FCC NLT 94.9%
27CFR
Proof Lot Analysis 200.0
30.23
Identification A - Specific Gravity USP NMT 0.7962 @ 15.56°C 0.7937
Identification A - Relative Density EP/BP 0.790 – 0.793 @ 20oC 0.7905
Specific Gravity JP d 15/15 0.794 – 0.797 0.794
Specific Gravity FCC Not more than 0.8096 @ 25.0°C 0.7871
Identification Test B USP/EP/BP Conforms to IR Spectra Pass
Identification 1 JP Conforms to IR Spectra Pass
An intense blue color appears on the paper and
Identification Test C EP/BP Pass
becomes paler after 10-15 minutes
Identification Test D EP/BP A yellow precipitate is formed within 30 minutes Pass
Water (wt%) ACS 0.2%, max 0.02%
Solubility in Water ACS To Pass Test
Solubility in Water FCC No haze or turbidity develops Pass
Solubility EP/BP Miscible with water and with methylene chloride
The Sample solution has the appearance of water
Color of Solution USP or is not more intensely colored than the standard Pass
solution
Color (APHA) ACS 10 max <10
Sample Solutions show the same clarity as that of
Clarity of Solution USP Pass
water, or their opalescence is not more
pronounced than that of Reference.
Purity 1 – Clarity and Color of Solution JP Pass
The mixture remains clear
Clear and Colorless. Dilution remains clear when
Appearance EP/BP Pass
compared with water
Acidity or Alkalinity USP/EP/BP The solution is pink (30ppm, as acetic acid) Pass
Purity 2 – Acidity or alkalinity JP A light red color develops Pass
Acidity (as acetic acid) FCC <0.003% Pass
Alkalinity (as NH3) FCC <3 mg/kg Pass
Form: Ethanol, Pure, 200, ACS/USP/EP/JP/FCC Rev. 2.5, 06/16, KAD
Disclaimer: For Industrial/Lab use only. Not intended as a Drug Substance, Medical Device or Disinfectant. Appropriate/legal use of this
product is the responsibility of the user. (Rev. # disclaimer only: Rev 3.6, 07/15, PD)
 Page 2 of 3
MONO- TYPICAL
TEST SPECIFICATION
GRAPH RESULT
Titrable Acid ACS 0.0005 meq/g max. <0.0003 meq/g
Titrable Base ACS 0.0002 meq/g max. <0.0001 meq/g
Fusel Oil FCC To Pass Test Pass
Acetone ACS 0.001% max. <0.001%
Isopropyl Alcohol 0.003% max. <0.003%
Ketones, Isopropyl Alcohol FCC To Pass Test Pass
Methanol ACS 0.1% max <0.1%
FCC To Pass Test Pass
Substances Darkened by Sulfuric Acid ACS/FCC To Pass Test Pass
Substances Reducing Permanganate ACS/FCC To Pass Test Pass
Lead FCC NMT 0.5 mg/kg Pass
Limit of Nonvolatile Residue USP The weight of the residue does not exceed 2.5 mg 0.5mg
Nonvolatile Residue FCC NMT 0.003% <0.001%
Residue on Evaporation ACS NMT 0.001% 0.0006%
Residue on Evaporation EP/BP 25 ppm, max <10 ppm
Purity 5 - Residue on Evaporation JP NMT 2.5 mg 0.5mg
Examine between 235nm – 340nm.
240nm 0.40 max. 0.29
UV Absorbance USP/EP/BP 250nm-260nm 0.30 max. 0.11
Purity 4 - Other Impurities (absorbance) JP 270nm-340nm 0.10 max. 0.02
The spectrum shows a steadily descending curve Pass
with no observable peaks or shoulders
Methanol 200 ppm max. <5 ppm
Volatile Impurities USP/EP/BP Sum of Acetal and Acetaldehyde 10ppm max None Detected
Purity 3 – Volatile Impurities JP Benzene 2ppm max. None Detected
Total of all other impurities 300ppm <50ppm

Form: Ethanol, Pure, 200, ACS/USP/EP/JP/FCC Rev. 2.5, 06/16, KAD

Disclaimer: For Industrial/Lab use only. Not intended as a Drug Substance, Medical Device or Disinfectant. Appropriate/legal use of this
product is the responsibility of the user. (Rev. # disclaimer only: Rev 3.6, 07/15, PD)
 Page 3 of 3

Permitted Concentrations of Elemental Impurities Following Option 1 Guideline in drug

products, drug substances and excipients1
Reported in µg/g (ppm)
TYPICAL
Parenteral
Oral Concentration Inhalation RESULT
Element Class Concentration
μg/g Concentration μg/g (in µg/g)
μg/g
(ppm)
Cd (Cadmium) 1 0.5 0.2 0.2 0.00
Pb (Lead) 1 0.5 0.5 0.5 0.00
As (Arsenic) 1 1.5 1.5 0.2 0.00
Hg (Mercury) 1 3 0.3 0.1 0.00
Co (Cobalt) 2A 5 0.5 0.3 0.00
V (Vanadium) 2A 10 1 0.1 0.00
Ni (Nickel) 2A 20 2 0.5 0.00
Tl (Thallium) 2B 0.8 0.8 0.8 0.00
Au (Gold) 2B 10 10 0.1 0.00
Pd (Palladium) 2B 10 1 0.1 0.00
Ir (Iridium) 2B 10 1 0.1 0.00
Os (Osmium) 2B 10 1 0.1 0.00
Rh (Rhodium) 2B 10 1 0.1 0.00
Ru (Ruthenium) 2B 10 1 0.1 0.00
Se (Selenium) 2B 15 8 13 0.00
Ag (Silver) 2B 15 1 0.7 0.00
Pt (Platinum) 2B 10 1 0.1 0.00
Li (Lithium) 3 55 25 2.5 0.00
Sb (Antimony) 3 120 9 2 0.00
Ba (Barium) 3 140 70 30 0.00
Mo (Molybdenum) 3 300 150 1 0.00
Cu (Copper) 3 300 30 3 0.00
Sn (Tin) 3 600 60 6 0.00
Cr (Chromium) 3 1100 110 0.3 0.00
1Includes all requirements for ICH Q3D-Step 4 version, EMA (EP) 5.2 and USP <232> and <233> General Chapters.

Form: Ethanol, Pure, 200, ACS/USP/EP/JP/FCC Rev. 2.5, 06/16, KAD

Disclaimer: For Industrial/Lab use only. Not intended as a Drug Substance, Medical Device or Disinfectant. Appropriate/legal use of this
product is the responsibility of the user. (Rev. # disclaimer only: Rev 3.6, 07/15, PD)