1.02497

1-Methyl-2-pyrrolidone

for headspace gas chromatography SupraSolv^®

• Synonym(s): 1-Methyl-2-pyrrolidone, NMP, N-Methyl-2-pyrrolidone
• CAS Number: 872-50-4
• Molecular Weight: 99.13
• MDL number: MFCD00003193
• EC Index Number: 212-828-1

Properties

• vapor pressure: 0.32 hPa ( 20 °C)
• Quality Level: 100
• product line: SupraSolv^®
• Assay: ≥99.8% (GC)
• form: liquid
• autoignition temp.: 245 °C
• potency: 3598 mg/kg LD₅₀, oral (Rat); 8000 mg/kg LD₅₀, skin (Rabbit)
• expl. lim.: 1.3-9.5 % (v/v)
• technique(s): GC-HS: suitable
• pH: 8.5-10.0 (20 °C, 100 g/L in H₂O)
• bp: 202 °C/1013 hPa
• mp: -24 °C
• transition temp: flash point 91 °C
• solubility: 1000 g/L
• density: 1.03 g/cm³ at 20 °C
• storage temp.: 2-30°C
• InChI: 1S/C5H9NO/c1-6-4-2-3-5(6)7/h2-4H2,1H3
• InChI key: SECXISVLQFMRJM-UHFFFAOYSA-N

Description

General description

SupraSolv^® high-purity solvents are specially designed for headspace-gas chromatography (HS-GC) for the analysis of residual solvents (RS) in active pharmaceutical ingredients, excipients and drug products according to Ph. Eur and USP. The concentrations of RS for high purity solvents are specified following ICH (International Council for Harmonizaton of Technical Requirements for Registration of Pharmaceuticals for Human Use) Guideline Q3C “Impurities: Guideline for Residual Solvents”.

Application

Intended for sensitive detection of analytes of ICH classes 1, 2 and 3 in residue and environmental analysis:

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

Legal Information

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

Safety Information

• Pictograms: GHS07,GHS08
• Signal Word: Danger
• Hazard Statements: H315 - H319 - H335 - H360D
• Precautionary Statements: P202 - P261 - P264 - P302 + P352 - P305 + P351 + P338 - P308 + P313
• Hazard Classifications: Eye Irrit. 2 - Repr. 1B - Skin Irrit. 2 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 1
• Flash Point(F): 195.8 °F - Pensky-Martens closed cup
• Flash Point(C): 91 °C - Pensky-Martens closed cup