PHR1149

Acetaminophen Related Compound J

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 4′-Chloroacetanilide, N-(4-Chlorophenyl)acetamide, Acetic acid 4-chloroanilide, NSC 40563, NSC 444
• Linear Formula: CH₃CONHC₆H₄Cl
• CAS Number: 539-03-7
• Molecular Weight: 169.61
• Beilstein: 509638
• EC Number: 208-707-8
• MDL number: MFCD00000612
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823167
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0001945; traceable to USP 1003100
• API family: paracetamol, acetaminophen
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 176-178 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: CC(=O)Nc1ccc(Cl)cc1
• InChI: 1S/C8H8ClNO/c1-6(11)10-8-4-2-7(9)3-5-8/h2-5H,1H3,(H,10,11)
• InChI key: GGUOCFNAWIODMF-UHFFFAOYSA-N

Description

General description

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.

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.

It is an impurity of the widely used antipyretic and analgesic drug acetaminophen, also known as paracetamol.

Application

This pharmaceutical secondary standard can also be used as follows:

• Separation and estimation of acetaminophen and its process impurities in commercial acetaminophen tablets using high-performance liquid chromatography (HPLC)
• Development and validation of HPLC-based stability indicating method for the determination of acetaminophen, chlorpheniramine maleate, and their possible degradation products in an over-the-counter syrup formulation
• Detection and quantification of paracetamol, phenylephrine hydrochloride, and paracetamol impurities in pharmaceutical formulations using four chemometric-based spectrophotometric methods
• Impurity analysis of a combined suppository dosage form of paracetamol, codeine phosphate hemihydrate, and pitophenone hydrochloride using ion-pair reversed-phase liquid chromatography in combination with UV detection
• Development of a thin-layer chromatography method combined with densitometry for the separation of acetaminophen and its related impurities from commercial dosage forms

Analysis Note

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

Other Notes

Values of analytes vary lot to lot.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0397 in 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: H315,H319,H335
• Precautionary Statements: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable