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

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