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Merck

PHR1098

N-Acetyl-L-cysteine

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

LNAC, NAC

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Fórmula lineal:
HSCH2CH(NHCOCH3)CO2H
Número CAS:
Peso molecular:
163.19
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
EC Number:
210-498-3
Beilstein/REAXYS Number:
1724426
MDL number:
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Quality Level

grade

certified reference material, pharmaceutical secondary standard

agency

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

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 and EP (PhEur) primary standards, where they are available.

Other Notes

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.
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.
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.


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hcodes

Hazard Classifications

Eye Irrit. 2

Clase de almacenamiento

13 - Non Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable



Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Pharmacokinetics of N-acetylcysteine in man.
Borgstrom L, et al.
European Journal of Clinical Pharmacology, 31(2), 217-222 (1986)
Spectrophotometric determination of N-acetyl-L-cysteine and N-(2-mercaptopropionyl)-glycine in pharmaceutical preparations.
Kukoc-Modun L and Radic N
International Journal of Analytical Chemistry, 2011(1-2), 191-199 (2011)
Quantitative analysis of N-acetylcysteine and its pharmacopeial impurities in a pharmaceutical formulation by liquid chromatography-UV detection-mass spectrometry.
Toussaint B,
Journal of Chromatography A, 896(1-2), 191-199 (2000)