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1.00399

N,N-Dimethylacetamide

for headspace gas chromatography SupraSolv®

別名:

N,N-Dimethylacetamide, Acetic acid dimethylamide, Acetyldimethylamine, DMAC, DMA, DMA

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この商品について

化学式:
CH3CON(CH3)2
CAS番号:
127-19-5
分子量:
87.12
UNSPSC Code:
12352111
EC Index Number:
204-826-4
NACRES:
NA.03
MDL number:
MFCD00008686
Assay:
≥99.8% (GC)
Technique(s):
GC-HS: suitable
Bp:
165-166 °C/1013 hPa
Vapor pressure:
1.76 hPa ( 20 °C)
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Quality Segment

100

agency

according to Ph. Eur., according to USP

vapor pressure

1.76 hPa ( 20 °C)

product line

SupraSolv®

assay

≥99.8% (GC)

form

liquid

autoignition temp.

400 °C

potency

5830 mg/kg LD50, oral (Rat)

expl. lim.

1.7-11.5 % (v/v)

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

≤3 mg/L

pH

4 (20 °C, 200 g/L in H2O)

bp

165-166 °C/1013 hPa

mp

-20 °C

transition temp

flash point 64 °C

solubility

soluble >1000 g/L

density

0.94 g/cm3 at 20 °C

storage temp.

2-30°C

SMILES string

N(C)(C)C(=O)C

InChI

1S/C4H9NO/c1-4(6)5(2)3/h1-3H3

InChI key

FXHOOIRPVKKKFG-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.

Features and Benefits

  • Regulatory compliance with ICH Q3C, Ph. Eur., and USP residual solvent guidelines, directly supporting pharmaceutical quality control workflows
  • Ultra-low intrinsic volatile impurity content, eliminating solvent-derived interferences in the headspace chromatogram and ensuring an unobstructed baseline
  • Batch-to-batch consistency, ensuring reproducibility across analytical campaigns

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

Complete GC Workflow Guide for ICH Q3C(R9) and USP<467>Compliance

Explore various labsafety 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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pictograms

Health hazardExclamation mark
GHS08,GHS07

signalword

Danger

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Eye Irrit. 2 - Repr. 1B

wgk

WGK 2

flash_point_f

147.2 °F - closed cup

flash_point_c

64 °C - closed cup

保管分類

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

適用法令

試験研究用途を考慮した関連法令を主に挙げております。化学物質以外については、一部の情報のみ提供しています。 製品を安全かつ合法的に使用することは、使用者の義務です。最新情報により修正される場合があります。WEBの反映には時間を要することがあるため、適宜SDSをご参照ください。

Substances Subject to be Indicated Names

ishl_indicated

Substances Subject to be Notified Names

ishl_notified

Class I Designated Chemical Substances

prtr

Group 4: Flammable liquids + Type 2 petroleums + Hazardous rank III + Water soluble liquid

fsl

1003998890: + 1003990500: + 1003990000: + 1003991007: + 1003991000: + 1003991008:

jan

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