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Merck

1.00577

suitable for GC-HS, SupraSolv®, according to USP and Ph. Eur.

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この商品について

化学式:
H2O
CAS番号:
分子量:
18.02
UNSPSC Code:
41104213
NACRES:
NA.03
MDL number:
Beilstein/REAXYS Number:
2050024
Technique(s):
GC-HS: suitable
Bp:
100 °C (lit.)
Vapor pressure:
23 hPa ( 20 °C)
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製品名

水, for headspace gas chromatography SupraSolv®

Quality Segment

agency

according to Ph. Eur., according to USP

vapor pressure

23 hPa ( 20 °C)

product line

SupraSolv®

form

liquid

technique(s)

GC-HS: suitable

impurities

≤1 μg/g Every residual solvent of class 1 acc. to ICH, ≤10 μg/g Every residual solvent of class 2 acc. to ICH, ≤50 μg/g Every residual solvent of class 3 acc. to ICH

evapn. residue

≤5 mg/L

refractive index

n20/D 1.34 (lit.)

pH

7 (20 °C)

bp

100 °C (lit.)

mp

0 °C (lit.)

density

1.000 g/mL at 3.98 °C (lit.)

storage temp.

2-30°C

SMILES string

O

InChI

1S/H2O/h1H2

InChI key

XLYOFNOQVPJJNP-UHFFFAOYSA-N

General description

SupraSolv® for headspace gas chromatography (GC-HS) is a dedicated high-purity solvent grade specifically formulated to meet the stringent analytical demands of residual solvent determination in pharmaceutical active pharmaceutical ingredients (APIs), drug products, and other regulated matrices.In headspace GC, the solvent serves as the diluent medium in which the sample is dissolved prior to equilibrium partitioning of volatile analytes into the gaseous headspace phase for subsequent chromatographic injection. Consequently, the chemical purity of the solvent is of critical analytical importance: any residual volatile impurities intrinsic to the solvent matrix may co-elute with target analytes, generating false-positive signals or suppressing accurate quantification. SupraSolv® headspace solvents are therefore specifically developed and tested to contain extremely low concentrations of residual solvents, as mandated by regulatory guidelines.

Application

SupraSolv® headspace GC solvents are indispensable in pharmaceutical residual solvent testing, polymer and excipient quality control, food packaging safety assessment, and industrial material characterization — analytical contexts in which solvent purity is a direct regulatory and safety requirement, and where the integrity of trace-level volatile quantification is non-negotiable.

Analysis Note

SupraSolv® headspace solvents adhere to the residual solvent classification thresholds defined by the International Council for Harmonisation (ICH Q3C) and referenced in pharmacopoeial standards (Ph. Eur. and USP), with certified limits including:
  • Class 1 solvents (known human carcinogens / environmental hazards): ≤ 1 µg/g
  • Class 2 solvents (non-genotoxic, dose-dependent toxicants): ≤ 10 µg/g
  • Class 3 solvents (low toxic potential): ≤ 50 µg/gThese specifications are verified lot-by-lot via GC/HS analysis, providing robust certification of compliance and analytical traceability.

Other Notes

Explore various lab safety accessories and equipment for safe handling of solvents to increase your safety level from the first usage.

Legal Information

SUPRASOLV is a registered trademark of Merck KGaA, Darmstadt, Germany


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保管分類

12 - Non Combustible Liquids

wgk

nwg

flash_point_f

Not applicable

flash_point_c

Not applicable



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