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PHR1669

Supelco

Lidocaine Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
2,6-Dimethylaniline, Lidocaine Impurity A; 2,6 DMA, 2,6-Xylidine, 2-Amino-1,3-dimethylbenzene, 2-Amino-m-xylene
Linear Formula:
(CH3)2C6H3NH2
CAS Number:
Molecular Weight:
121.18
Beilstein:
636332
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. Y0001575

vapor pressure

<0.01 mmHg ( 20 °C)

API family

lidocaine

CofA

current certificate can be downloaded

packaging

pkg of 100 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

refractive index

n20/D 1.560 (lit.)

bp

214 °C/739 mmHg (lit.)

mp

10-12 °C (lit.)

density

0.984 g/mL at 25 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

Cc1cccc(C)c1N

InChI

1S/C8H11N/c1-6-4-3-5-7(2)8(6)9/h3-5H,9H2,1-2H3

InChI key

UFFBMTHBGFGIHF-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.

The standard is a certified reference material (CRM) qualified with instruments validated according to good manufacturing practices (GMP) using pharmacopeia monograph methods. It is supplied with a comprehensive certificate containing information on traceability assay results, certified purity, homogeneity tests, uncertainty statement, and stability assessment.

Lidocaine Related Compound A is a primary aromatic amine and a major metabolite of the anesthetic lidocaine. It is used as a starting material in the manufacturing of various anesthetics like lidocaine, bupivacaine, mepivacaine, etidocaine, ropivacaine, pyrrocaine, and xylazine.

Application

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.

This pharmaceutical secondary standard can also be used as follows:

  • Development of an impurity selective reverse phase-high performance liquid chromatography (RP-HPLC) method to determine dexpanthenol, lidocaine hydrochloride, mepyramine maleate, and their related substances in topical dosage forms
  • Testing a selective high-performance liquid chromatography-diode array detection (HPLC-DAD) method, developed for the simultaneous analysis of miconazole nitrate and lidocaine hydrochloride in their combined oral gel dosage form, for its stability-indicating properties
  • Evaluation of a high-performance liquid chromatography-diode array detection (HPLC-DAD) procedure― for its stability indicating properties, developed to determine nitrofurazone and lidocaine hydrochloride in their combined dosage form
  • Separation of 2,6-Dimethylaniline, its isomeric impurities, and other related impurities by isocratic and reverse-phase ultra-performance liquid chromatographic (UPLC) method
  • analyze a binary mixture of lidocaine hydrochloride and cetylpyridinium chloride in presence of lidocaine impurity A by spectrophotometric methods
  • determine lidocaine hydrochloride-related substance by analytical methods in pharmaceutical dosage forms

Analysis Note

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

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3048 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.

related product

Product No.
Description
Pricing

Signal Word

Warning

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Aquatic Chronic 2 - Carc. 2 - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

WGK

WGK 3

Flash Point(F)

closed cup

Flash Point(C)

closed cup

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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Development and Validation of RP-UPLC Method for 2, 6-Dimethylaniline, Its Isomers, and Related Compounds Using Design of Experiments
Marisetti VM and Katari NK
Chromatographia, 84(4), 359-369 (2021)
Development and Validation of RP-UPLC Method for 2, 6-Dimethylaniline, Its Isomers, and Related Compounds Using Design of Experiments
Marisetti VM and Katari NK
Chromatographia, 84, 359-369 (2021)
Novel Green Potentiometric Method for the Determination of Lidocaine Hydrochloride and its Metabolite 2, 6-Dimethylaniline; Application to Pharmaceutical Dosage Form and Milk
Saad AS, et al.
Electroanalysis, 30(8), 1689-1695 (2018)
Simultaneous determination of dexpanthenol, lidocaine hydrochloride, mepyramine maleate and their related substances by a RP-HPLC method in topical dosage forms
Doganay A, et al.
Journal of Chromatographic Science, 56(10), 903-911 (2018)
Green spectrophotometric methods for the determination of a binary mixture of lidocaine hydrochloride and cetylpyridinium chloride in the presence of dimethylaniline
Merey HA, et al.
Spectrochimica Acta Part A: Molecular Spectroscopy, 242, 118743-118743 (2020)

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