1.02497

NMP

for headspace gas chromatography SupraSolv^®

• Sinónimos: 1-Metil-2-pirrolidona
• Número CAS: 872-50-4
• Peso molecular: 99.13
• UNSPSC Code: 41116105
• EC Index Number: 212-828-1
• NACRES: NA.03
• MDL number: MFCD00003193
• Assay: ≥99.8% (GC)
• Technique(s): GC-HS: suitable
• Bp: 202 °C/1013 hPa
• Vapor pressure: 0.32 hPa ( 20 °C)

Propiedades

• Nombre del producto: 1-Metil-2-pirrolidona, for headspace gas chromatography SupraSolv^®
• Quality Segment: 100
• agency: according to Ph. Eur., according to USP
• vapor pressure: 0.32 hPa ( 20 °C)
• 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
• impurities: ≤0.05% water, ≤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
• 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
• SMILES string: N1(CCCC1=O)C
• InChI: 1S/C5H9NO/c1-6-4-2-3-5(6)7/h2-4H2,1H3
• InChI key: SECXISVLQFMRJM-UHFFFAOYSA-N

Descripción

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

Información de seguridad

• Palabra de advertencia: Danger
• Indicaciones de precaución: P202 - P261 - P264 - P302 + P352 - P305 + P351 + P338 - P308 + P313
• Hazard Classifications: Eye Irrit. 2 - Repr. 1B - Skin Irrit. 2 - STOT SE 3
• Órganos diana: Respiratory system
• ¿Qué está pasando?: WGK 1
• Punto de inflamación (°F): 195.8 °F - Pensky-Martens closed cup
• Punto de inflamación (°C): 91 °C - Pensky-Martens closed cup
• Pictogramas: GHS08,GHS07
• Códigos de peligro: H315,H319,H335,H360D
• Clase de almacenamiento: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects