PHR1669
Lidocaine Related Compound A
Pharmaceutical Secondary Standard; Certified Reference Material
Synonym(s):
2,6-Dimethylaniline, Lidocaine Impurity A; 2,6 DMA, 2,6-Xylidine, 2-Amino-1,3-dimethylbenzene, 2-Amino-m-xylene
About This Item
Recommended Products
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
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
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
Footnote
Recommended products
related product
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
Storage Class
6.1A - Combustible, acute toxic Cat. 1 and 2 / very toxic hazardous materials
wgk_germany
WGK 3
flash_point_f
195.8 °F - closed cup
flash_point_c
91 °C - closed cup
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