Acetylcysteine Impurity D
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Acetylcysteine Impurity D

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N,S-Diacetyl-L-cysteine is a double-prodrugs of L-cysteine: differential protection against acetaminophen-induced hepatotoxicity in mice.

Category
L-Amino Acids
Catalog number
BAT-008969
CAS number
18725-37-6
Molecular Formula
C7H11NO4S
Molecular Weight
205.23
Acetylcysteine Impurity D
IUPAC Name
(2R)-2-acetamido-3-acetylsulfanylpropanoic acid
Synonyms
N,S-Diacetyl-L-cysteine; N-Acetylcysteine Acetate; Dacisteine; N,S-Diacetylcysteine; N-Acetylcysteine S-Acetate
Appearance
White Solid
Purity
> 95%
Melting Point
118-123°C
InChI
InChI=1S/C7H11NO4S/c1-4(9)8-6(7(11)12)3-13-5(2)10/h6H,3H2,1-2H3,(H,8,9)(H,11,12)/t6-/m0/s1
InChI Key
HSPYGHDTVQJUDE-LURJTMIESA-N
Canonical SMILES
CC(=O)NC(CSC(=O)C)C(=O)O

Acetylcysteine Impurity D, a chemical compound, emerged as an impurity during the synthesis of acetylcysteine, a crucial medication with diverse therapeutic utility. Here are four pivotal applications of Acetylcysteine Impurity D:

Quality Control in Pharmaceuticals: Acetylcysteine Impurity D functions as a reference standard in the pharmaceutical realm, playing a pivotal role in upholding the purity and quality of acetylcysteine products. By quantifying the levels of this impurity, manufacturers ensure compliance with stringent regulatory standards, safeguarding the safety and efficacy of the final pharmaceutical concoction. This meticulous process is essential for maintaining the integrity of medicinal formulations.

Analytical Method Development: Researchers harness the potential of Acetylcysteine Impurity D to innovate and validate analytical methods like high-performance liquid chromatography (HPLC) or mass spectrometry. These sophisticated methodologies are indispensable for accurately detecting and quantifying impurities in drug formulations. The stringent monitoring of impurity presence and levels aligns with pharmacopoeial guidelines, guaranteeing patient safety with unwavering precision.

Toxicological Studies: Delving into the realm of toxicology, scientists scrutinize Acetylcysteine Impurity D to unravel its potential toxicological ramifications and safety profile. By comprehensively assessing the toxicity of this impurity, researchers establish acceptable limits for its presence in acetylcysteine products, ensuring patient well-being and guiding the setting of safe dosage thresholds. This insightful exploration is paramount for averting adverse health outcomes and enhancing pharmaceutical safety standards.

Pharmaceutical Stability Testing: Amid the rigors of stability testing in acetylcysteine formulations, Acetylcysteine Impurity D emerges as a pivotal marker for product degradation. Through vigilant monitoring of impurity formation over time, researchers ascertain the shelf life and optimal storage conditions of the medication. The pursuit of minimal degradation is essential for preserving the therapeutic potency of acetylcysteine until its expiration date, underscoring the importance of meticulous stability assessments.

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