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Merck
CN

PHR1669

利多卡因相关化合物A

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

2,6-二甲基苯胺, 2,6-二甲苯胺, 2-氨基-1,3-二甲苯, 2-氨基间二甲苯

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线性分子式:
(CH3)2C6H3NH2
化学文摘社编号:
分子量:
121.18
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
EC Number:
201-758-7
Beilstein/REAXYS Number:
636332
MDL number:
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产品名称

利多卡因相关化合物A, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

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

InChI key

UFFBMTHBGFGIHF-UHFFFAOYSA-N

SMILES string

Cc1cccc(C)c1N

grade

certified reference material
pharmaceutical secondary standard

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

Quality Level

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Analysis Note

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

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

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.

Other Notes

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.
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.

signalword

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

存储类别

6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials

wgk

WGK 3

flash_point_f

195.8 °F - closed cup

flash_point_c

91 °C - closed cup

法规信息

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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)
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)
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)

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