PHR1148

4-Aminophenol (Acetaminophen Related Compound K) (Paracetamol Impurity K)

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 4-Aminophenol, 4-Hydroxyaniline
• Linear Formula: H₂NC₆H₄OH
• CAS Number: 123-30-8
• Molecular Weight: 109.13
• Beilstein: 385836
• EC Number: 204-616-2
• MDL number: MFCD00007869
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823166
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0001955; traceable to USP 1021204
• API family: mesalazine, paracetamol, acetaminophen
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 185-189 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: Nc1ccc(O)cc1
• InChI: 1S/C6H7NO/c7-5-1-3-6(8)4-2-5/h1-4,8H,7H2
• InChI key: PLIKAWJENQZMHA-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 a primary degradation product of the widely used antipyretic and analgesic drug acetaminophen, also known as paracetamol, formed on its hydrolysis.

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)
• Simultaneous electrochemical determination of acetaminophen and its impurity K using a reduced graphene oxide-titanium nitride (RGO-TiN) nanohybrid
• 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
• Determination of acetaminophen, pamabrom, and their impurities using high-performance thin layer chromatography (HPTLC) and reversed phase-high performance liquid chromatography (RP-HPLC), according to the ICH guidelines, in their combined dosage tablets
• Combined analysis of acetaminophen, chlorzoxazone, and their major degradation impurities using thin-layer chromatographic (TLC)-densitometric method in their combined dosage capsules

Analysis Note

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

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3043 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: GHS08,GHS07,GHS09
• Signal Word: Warning
• Hazard Statements: H302 + H332,H317,H341,H373,H410
• Precautionary Statements: P273 - P280 - P301 + P312 - P302 + P352 - P304 + P340 + P312 - P308 + P313
• Hazard Classifications: Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Muta. 2 - Skin Sens. 1 - STOT RE 2
• Target Organs: Kidney
• Storage Class Code: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable