PHR1098

N-Acetyl-L-cysteine

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): LNAC, NAC
• Linear Formula: HSCH₂CH(NHCOCH₃)CO₂H
• CAS Number: 616-91-1
• Molecular Weight: 163.19
• Beilstein: 1724426
• EC Number: 210-498-3
• MDL number: MFCD00004880
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823120
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 907; traceable to Ph. Eur. A0150000; traceable to USP 1009005
• API family: acetylcysteine
• CofA: current certificate can be downloaded
• storage condition: protect from light
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 106-108 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: CC(=O)N[C@@H](CS)C(O)=O
• InChI: 1S/C5H9NO3S/c1-3(7)6-4(2-10)5(8)9/h4,10H,2H2,1H3,(H,6,7)(H,8,9)/t4-/m0/s1
• InChI key: PWKSKIMOESPYIA-BYPYZUCNSA-N

Description

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
N-Acetyl-L-cysteine is an endogenous aminothiol which is a component of human plasma and urine. It finds use in clinical applications as a mucolytic agent typically administered by inhalation.

Application

N-Acetyl-L-cysteine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by liquid chromatography-mass spectrometry (LC-MS) and spectrophotometric techniques.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Antioxidant and mucolytic agent. Increases cellular pools of free radical scavengers. Reported to prevent apoptosis in neuronal cells but induce apoptosis in smooth muscle cells. Inhibits HIV replication. May serve as a substrate for microsomal glutathione transferase.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0297in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H319
• Precautionary Statements: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Hazard Classifications: Eye Irrit. 2
• Storage Class Code: 13 - Non Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable