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
• Linear Formula: (CH₃)₂C₆H₃NH₂
• CAS Number: 87-62-7
• Molecular Weight: 121.18
• Beilstein: 636332
• EC Number: 201-758-7
• MDL number: MFCD00007747
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823545
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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

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.

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

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Safety Information

• Pictograms: GHS08,GHS07,GHS09
• Signal Word: Warning
• Hazard Statements: H302 + H312 + H332,H315,H319,H335,H351,H411
• Precautionary Statements: P273 - P280 - P301 + P312 - P302 + P352 + P312 - P304 + P340 + P312 - P308 + P313
• 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 Code: 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