Certificate of analysis and
(..) conformity according to PharmEthyl®
European Pharmacopoeia
___ITEM ALC. PHARMETHYL 80 EP DATE (dd.mm.yyyy) 24.10.2018
PRODUCTED AND LOADED CRISTANOL BATCH NUMBER 090000046600
FROM (FACTORY NAME) +33 326 61 21 21 SATCHRMEASE DATE! 2370201
CUSTOMER ,ECNOLOGICA DE | A + Garcine
ALIMENTOS S.A. VALIDATED BY) ,Czine
~HAULIER KVG
7 RETESTDATE 10.2019
TRUCK ID NUMBER RFCU8803149 | REFERENCE NUMBER aseri7es
PO TASA
ORDER NUMBER FO TAS!
Unless mentioned otherwise the results relate to the alcohol prior to denaturing or hydration
‘Alcohol Paramotere ‘Specifications Result ‘eating procedure
Eman! Content at 20°0 2095 00,0 Méthode Phamaeopée Europeenne
‘Appearance Canora? ‘Comptes | Métro Phamacopée Europeerne
‘wb Canorme" Comptes | Metode Phamacopée Europeerne
test Conform” Compies | Méfode Phamacopée Europderne
Boling point 70s...s700 735 __|Metoge Pharmacopée Evropeenne
IDENTIFICATION specific gravity at2 0,790 S... $0,793 0.791 Méthode Pharmacopée Européenne 2.2.6
DENTIFICATION BIR Contorme Comptes Metrade Prarmecapes Européerne 2224
Anpoarane Lipide ncobre Clear, exouress | Méthode Phamacopée Euopéenne 22.162
Aciity or alkalinity (as acetic acid) pom (vv) 530 <30 | Méthode Pharmacopée Europeenne 7
UV absorption (240nm) S040 021 "Méthode Pharmacopée Européenne 2225
LV absorption (between 2801 and 260m) 030 0.09 Methode Prarmacapee Europeenne 2.2.25,
UV absorption (etween 270nm and 240m) (201 Metnode Pharmacopee Ewopéeme 22.25
LU absorption (2401280-260/270-240 a) || Gompses—Metnede Prarmaconée Européeme 2.2.25
Methanol ppm(wiv) $100 < 100 ‘Méthode Pharmacopée Européenne 2.2.28
‘Acetaldehyde + acetal (as acotaldehyde) ppm (vv) $10 <10 ‘Matnode Pharmacopde Européenne 2.2.28
Benzene | ppm (wiv) $2 <2 ‘Méthode Pharmacopée Européenne 2.2.28
im of al others impurtios | ppm iy +5900 900 Méthode Pharmacopée Européeane 22.28
Non volatile resiue bem (rw) 20 <20___ Méthode Phammaconée Euoptenne
Water content (PPM) opm = 1000 172 Menode KF (EN1S429)
Lead Content ppm 05 | 00 ePMS
Tota higher alcohols (PPM VIN) om Ed 0 Métrode OW Boisson spiumux (PG)
alysis realised on the batch by the laboratory of the loading plant.
Wording of characteristics:
- Appearance: Colouriese and clear liquid, impid, volatile, flammable, hygroscopic
+ Solubility: miscible with water and with methylene chlorid
-Flame Test: bums with blue flame without smoke
~ ABSORBANCE 240/250-260/270-240nm : regular descending curve without peak
ND : Not detected
‘Comments
Product complies
Monographie “Ethanol anhydre” 01/2015 : 1318 (pharmacopée Européenne 9éme édition)
Monograph "Ethanol anhydrous" 01/2018:1318 (European Ph. Sth edition)
This is a computer generated document raised upon the responsibility of the Quality manager. No signature is,
required
Etablished by CRISTANOL on behalf of CristalCo
"Sasma
CERTIFICATE OF ANALYSIS
ANHYDROUS ETHYL ALCOHOL (99,9%vol.)
EP GRADE
FOOD GRADE
Production date: 24°" Oct. 2018
Retest date: 24'" Oct. 2020
Batch nu.: Been.
Container nu, RFCU 880314-9, RFCU 880218-4, FPTU 600084-0
Reference nu.: 23571752, 23571753, 23571754
Order nu.: TASA-10
Test (Unit) Specification Result
Clarity of solution To Pass Test Pass
Color of solution To Pass Test Pass
Solubility Miscible with water Pass
Identification Test A 0,790 -0,793 0,791
Identification Test B To Pass Test Pass
Assay-Ethyl Alcohol at 20 8C (%vol.) 2995 100,0
Density at 20 8C (kg/liter) 0,709-0,793, 0,789
Water (%évol.) 0,4 <0,02
Nonvolatile Residue (ppm, m/v) $20 <20
Acidity and Alkalinity as Acetic acid (ppm) $30 <30
Volatile impurities (6C)
Methanol (ppm, v/v) $100 <100
Acetaldehyde (ppm, v/v) 10 s10
Benzene (ppm, v/v) 82 <2
Total of All Others (ppm, v/v) <300 <300
Fusel oil (ppm, v/v) s5 o
Lead (Pb) (ppm, v/v) $05 0
Product Complies with the current EP, HACCP and |S09001 principles.
JECFA~ Ethyl Alcohol CAS: 64-17-5
Product Complies with the GMO declaration according to the EU regulation 1829/2003 and
the EU regulation 1830/2003.
Issue date: 25' Oct. 2018, The Netherlands.
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