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PHR1148

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

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
4-Aminophenol, 4-Hydroxyaniline
Linear Formula:
H2NC6H4OH
CAS Number:
Molecular Weight:
109.13
Beilstein:
385836
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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

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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.

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Signal Word

Warning

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

危险化学品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Simultaneous Estimation of Acetaminophen, Chlorpheniramine Maleate, Methyl Paraben, Propyl Paraben, Sodium Benzoate and Related Impurities in Over-the-Counter Syrup Formulation
Palakurthi AK and Dongala T
Pharmaceutical Chemistry Journal, 1-7 (2022)
Facile green synthesis of graphene-titanium nitride hybrid nanostructure for the simultaneous determination of acetaminophen and 4-aminophenol
Kong F-Y, et al.
Sensors and Actuators B, Chemical, 213, 397-403 (2015)
Y Xu et al.
Clinical chemistry, 36(11), 1941-1944 (1990-11-01)
A sandwich-type heterogeneous enzyme immunoassay with flow-injection analysis for alpha-fetoprotein (AFP) in human serum has been developed. 4-Aminophenol, the product of enzymatic reaction, is detected amperometrically. The interassay CV for this electrochemical enzyme immunoassay was less than 8.2%, with a
Chengzhou Zhu et al.
Nanoscale, 3(10), 4376-4382 (2011-09-10)
In this paper, we reported a simple, aqueous-phase route to the synthesis of two-dimensional graphene/SnO(2) composite nanosheets (GSCN) hybrid nanostructures consisting of 5 nm Pt nanoparticles supported on the both sides of GSCN. Functional two-dimensional GSCN were obtained through the
Mohammad Mahdi Najafpour et al.
Dalton transactions (Cambridge, England : 2003), 41(14), 3906-3910 (2012-02-14)
We describe here the ability of manganese oxide monosheets to aggregate to form layered structures with 4-aminophenol molecules. These aggregated monosheets could be considered as the first step to synthesize a self-assembled layered hybrid of phenol-manganese ions with phenol and

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