P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical/ ventilating/ lighting equipment. P242: Use non-sparking tools. P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P403 + P233: Store in a well-ventilated place. Keep container tightly closed.
Signal Word
Danger
RTECS
KQ6300000
Storage class
3 Flammable liquids
WGK
WGK 1 slightly hazardous to water
Disposal
1 Strongly contaminated halogen-free organic solvents: container A.
Safety Information
Categories of danger
highly flammable
Product Usage Statements
Storage and Shipping Information
Storage
Store at +2°C to +25°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RID
UN 1170 , 3, II
Declaration (transport by air) IATA-DGR
UN 1170 , 3, II
Declaration (transport by sea) IMDG-Code
UN 1170 , 3, II
Supplemental Information
Specifications
Assay (m/m)
92.6 - 95.2 %
Assay (V/V)
95.1 - 96.9 %
Identity (IR)
conforms
Identity 1 (ChP)
conforms
Appearance
conforms
Clarity and color of solution (ChP)
conforms
Acidity or alkalinity
≤ 30 ppm
Acidity or alkalinity (ChP)
conforms
Density (d 20 °C/20 °C)
0.805 - 0.812
Density (d 20 °C/20 °C) (ChP)
≤ 0.8129
Absorbance (at 240 nm)
≤ 0.40
Absorbance (between 250 nm and 260 nm)
≤ 0.30
Absorbance (between 270 nm and 340 nm)
≤ 0.10
The spectrum shows a steadily descending curve with no observable peaks or shoulders
conforms
Absorbance (ChP) (at 240 nm)
≤ 0.08
Absorbance (ChP)
(between 250 nm and 260 nm)
≤ 0.06
Absorbance (ChP)
(between 270 nm and 340 nm)
≤ 0.02
Volatile impurities (GC) (Acetaldehyde and Acetal)
≤ 10 ppm
Volatile impurities (GC) (Benzene)
≤ 2 ppm
Volatile impurities (GC) (Methanol)
≤ 100 ppm
Volatile impurities (GC) (Total of other impurities)
≤ 300 ppm
Other residual solvents (ICH Q3C)
excluded by production process
Evaporation residue
≤ 25 mg/l
Non-volatile matter
≤ 25 mg/l
Bacterial endotoxins
≤ 2.5
Parameter with periodic testing ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Total aerobic microbial count (TAMC) ≤ 100 CFU/ml Total combined yeasts/moulds count (TYMC) ≤ 10 CFU/ml
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). Conforms to Ph Eur, BP, ChP.
