Lidocaine Related Compound A
SIAL/PHR1669 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: 2,6-Dimethylaniline; 2,6-Dimethylaniline; Lidocaine Impurity A; 2,6 DMA; 2,6-Xylidine; 2-
Empirical Formula (Hill Notation): C8H11N
Molecular Weight: 121.18
EC Number: 201-758-7
MDL Number: MFCD00007747
Linear Formula: (CH3)2C6H3NH2
Product Type: Chemical
| agency | traceable to Ph. Eur. Y0001575 |
| application(s) | pharmaceutical (small molecule) |
| bp | 214 °C/739 mmHg (lit.) |
| CofA | current certificate can be downloaded |
| density | 0.984 g/mL at 25 °C (lit.) |
| format | neat |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C8H11N/c1-6-4-3-5-7(2) |
| InChI key | UFFBMTHBGFGIHF-UHFFFAOYSA |
| mp | 10-12 °C (lit.) |
| packaging | pkg of 100 mg |
| Quality Level | 100  |
| 300 |
|
| refractive index | n |
| SMILES string | Cc1cccc(C)c1N |
| storage temp. | 2-30°C |
| technique(s) | gas chromatography (GC): suitable |
| HPLC: suitable | |
| vapor pressure | <0.01 mmHg ( 20 °C) |
| Analysis Note: | These secondary standards offer multi-traceability to the USP, EP and BP 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 |
| 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. |
| 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. |
| Symbol |    GHS07,GHS08,GHS09 |
| Signal word | Warning |
| Hazard statements | H302 + H312 + H332 - H315 - H335 - H351 - H411 |
| Precautionary statements | P273 - P280 - P301 + P312 - P302 + P352 + P312 - P304 + P340 + P312 - P308 + P313 |
| RIDADR | UN 1711 6.1 / PGII |
| WGK Germany | WGK 3 |
| Flash Point(F) | 195.8 °F - closed cup |
| Flash Point(C) | 91 °C - closed cup |
| bp | 214 °C/739 mmHg (lit.) |
| mp | 10-12 °C (lit.) |
| Density | 0.984 g/mL at 25 °C (lit.) |
| Refractive Index | n |
| Storage Temp. | 2-30°C |
| UNSPSC | 41116107 |