ALC. Pharmethyl 99% GMP INJ RM
USP, EP, BP, JP, Injectable Grade
CAS #:
64-17-5
Molecular Formula:
C2H5OH
Synonym:
Dehydrated Alcohol, Ethanol 99%, Ethanol Absolute
Molecular Weight:
46.07 g/mol
Overview
- Pharmethyl® is the essential reference for the use of alcohol as a raw material for pharmaceutical use (MPUP): active principle, excipient, solvent.
- Pharmethyl®: two ranges adapted to the most demanding regulations and the highest expectations of the pharmaceutical and biotechnology industry.
- A Pharmethyl® Standard range produced by batch and analyzed according to the European, American or Japanese pharmacopoeia.
- A Pharmethyl® GMP range which guarantees the production and packaging on GMP certified sites, respecting Good Manufacturing Practices for active substances.
- Outstanding technical features and alcohol quality
- Opting for Pharmethyl® means making sure you have all the quality certifications, from the most classic to the most specific (BSE / TSE, Allergens, ICH Q3C & ICH Q3D, ...).
- Made from sustainable agricultural raw materials, Pharmethyl® products are guaranteed GMO-free and Kosher certified.
| Characters | Unit | Specification |
|---|---|---|
| Ethanol content at 15,56°c | %v/v | ≥ 99,5 |
| Ethanol content at 15 °c | %v/v | ≥ 99,5 |
| Ethanol content at 20°c | %v/v | ≥ 99,5 |
| Specific gravity at 15,56°c | ≤ 0,796 | |
| Specific gravity at 15°c | 0,794 ≤ ...≤ 0,797 | |
| Identification a: relative density at 20°c | 0,790 ≤ ...≤ 0,793 | |
| Identification b: ir | Complies a | |
| Identification c | Complies b | |
| Identification d | Complies c | |
| Appearance/ clarity and color of solution | Complies d | |
| Solubility | Complies e | |
| Flame test | Complies f | |
| Boiling point | °C | 77,0 ≤ ...≤ 79,0 |
| Acidity Or Alkalinity (As Acetic Acid) | ppm v/v | ≤ 30g |
| UV Absorption (240nm) | ≤ 0,40 | |
| UV Absorption Between 250 Nm And 260 Nm | ≤ 0,30 | |
| UV Absorption 240/250-260/270- 340 Nm | ≤ 0,10 | |
| UV Absorption Between 270 Nm À 340 Nm | Complies h | |
| Volatile Impurities | ||
| Methanol | ppm v/v | ≤ 100 |
| Acetaldehyde + Acetal (As Acetaldehyde) | ppm v/v | ≤ 10 |
| Benzene | ppm v/v | ≤ 2 |
| Sum of all other impurities | ppm v/v | ≤ 300 |
| Non Volatile Impurities | ||
| Residue on evaporation | ppm m/v | ≤ 25 |
| Elemental Impurities | ||
| Cadmium | µg/g | ≤ 0.2 |
| Plomb | µg/g | ≤ 0.5 |
| Arsenic | µg/g | ≤ 0.2 |
| Mercury | µg/g | ≤ 0.1 |
| Cobalt | µg/g | ≤ 0.3 |
| Vanadium | µg/g | ≤ 0.1 |
| Nickel | µg/g | ≤ 0.5 |
| Lithium | µg/g | ≤ 2.5 |
| Antimony | µg/g | ≤ 2 |
| Baryum | µg/g | ≤ 30 |
| Molybdenum | µg/g | ≤ 1 |
| Copper | µg/g | ≤ 3 |
| Tin | µg/g | ≤ 6 |
| Chromium | µg/g | ≤ 0.3 |
| Endotoxin | UI/ml | ≤ 0.25 |
| Bacterial Count | UFC/L | ≤ 10 |
| a Conform to reference spectrum | ||
| b After a few minutes, an intense blue colour appears on the paper and becomes paler after 10-15 minutes | ||
| c A yellow precipitate is formed within 30 minutes | ||
| d Flammable, liquid, hygroscopic and volatile/ substance to be examined show the same clarity and has the appearance of water | ||
| e Miscible with water and with methylene chlorid | ||
| f burns with blue flame without smoke | ||
| g The solution is pink | ||
| h The spectrum shows a steadily descending curve with no observable peaks or shoulders | ||
Shelf Life/Retest Date: Based on in-house stability studies, we formally set the date of retest of Pharmethyl grade at the date of release of each individual batch + 24 months (in neutral container) when stored under recommended conditions.
Storage/Shipping Conditions:
- Store in a cool well-ventilated area, away from sources of ignition. Separated from oxidants, strong mineral acids.
- Stable and dry environment at ambient temperatures.
- Any variations of temperature may affect shelf life of alcohol.
- Alcoholic strength and UV parameters may be impacted by exposure to air and shelf life being reduced accordingly.
Pack Sizes: 500 ml, 25 L and 215 L
