This certificate analyzes a batch of pharmaceutical grade ethanol according to European Pharmacopoeia standards. It lists the product and batch details, specifications, test results, and comments. All test results were within specifications and the product was found to comply with the monograph for anhydrous ethanol in the European Pharmacopoeia 9th edition. The certificate was generated by the quality manager of the producing company to verify the quality of the ethanol batch.
This certificate analyzes a batch of pharmaceutical grade ethanol according to European Pharmacopoeia standards. It lists the product and batch details, specifications, test results, and comments. All test results were within specifications and the product was found to comply with the monograph for anhydrous ethanol in the European Pharmacopoeia 9th edition. The certificate was generated by the quality manager of the producing company to verify the quality of the ethanol batch.
This certificate analyzes a batch of pharmaceutical grade ethanol according to European Pharmacopoeia standards. It lists the product and batch details, specifications, test results, and comments. All test results were within specifications and the product was found to comply with the monograph for anhydrous ethanol in the European Pharmacopoeia 9th edition. The certificate was generated by the quality manager of the producing company to verify the quality of the ethanol batch.
This certificate analyzes a batch of pharmaceutical grade ethanol according to European Pharmacopoeia standards. It lists the product and batch details, specifications, test results, and comments. All test results were within specifications and the product was found to comply with the monograph for anhydrous ethanol in the European Pharmacopoeia 9th edition. The certificate was generated by the quality manager of the producing company to verify the quality of the ethanol batch.
conformity according to European Pharmacopoeia ITEM ALC. PHARMETHYL 99 EP DATE (dd.mm.yyyy) 13.02.2019 PRODUCTED AND LOADED CRISTANOL BATCH NUMBER 090000049950 FROM (FACTORY NAME) +33 3 26 61 21 21 BATCH RELEASE DATE 12.02.2019 TECNOLOGICA DE CUSTOMER VALIDATED BY Alice PERSON ALIMENTOS S.A. HAULIER BRAID RETEST DATE 01.2020 TRUCK ID NUMBER EXFU663961-6 REFERENCE NUMBER 23607609 ORDER NUMBER TASA 11-1st
Unless mentioned otherwise the results relate to the alcohol prior to denaturing or hydration
Alcohol Parameters Units Specifications Result Testing procedure
Ethanol Content at 20°C %v/v 99,5 100,0 Méthode Pharmacopée Européenne Appearance Conforme* Complies Méthode Pharmacopée Européenne Solubility Conforme* Complies Méthode Pharmacopée Européenne Flame test Conforme* Complies Méthode Pharmacopée Européenne Boiling point °C 77,0 ... 79,0 78,8 Méthode Pharmacopée Européenne ID A : Specific gravity at 20°C 0,790 ... 0,793 0,791 Méthode Pharmacopée Européenne 2.2.5 IDENTIFICATION B : IR Conforme Complies Méthode Pharmacopée Européenne 2.2.24 Appearance Limpide incolore Clear, colourless Méthode Pharmacopée Européenne 2.2.1et2 Acidity or alkalinity (as acetic acid) ppm (v/v) 30 < 30 Méthode Pharmacopée Européenne UV absorption (240nm) 0,40 0,26 Méthode Pharmacopée Européenne 2.2.25 UV absorption (between 250nm and 260 nm) 0,30 0,11 Méthode Pharmacopée Européenne 2.2.25 UV absorption (between 270nm and 340 nm) 0,10 0,02 Méthode Pharmacopée Européenne 2.2.25 UV absorption (240/250-260/270-340 nm) Conforme* Complies Méthode Pharmacopée Européenne 2.2.25 Methanol ppm (v/v) 100 < 100 Méthode Pharmacopée Européenne 2.2.28 Acetaldehyde + acetal (as acetaldehyde) ppm (v/v) 10 < 10 Méthode Pharmacopée Européenne 2.2.28 Benzene ppm (v/v) 2 <2 Méthode Pharmacopée Européenne 2.2.28 Sum of all others impurities ppm (v/v) 300 < 300 Méthode Pharmacopée Européenne 2.2.28 Non volatile residue ppm (m/v) 20 < 20 Méthode Pharmacopée Européenne Water content (PPM) ppm 1000 318 Méthode KF (EN15489) Lead Content ppm 0,5 0,0 ICP MS Total higher alcohols (PPM V/V) ppm (v/v) 5 0 Méthode OIV Boissons spiritueux (CPG)
Analysis realised on the batch by the laboratory of the loading plant.
* Wording of characteristics: - Appearance: Colourless and clear liquid, limpid, volatile, flammable, hygroscopic - Solubility: miscible with water and with methylene chlorid - Flame Test: burns with blue flame without smoke - ABSORBANCE 240/250-260/270-340nm : regular descending curve without peak
