PHR1756

Bupivacaine Related Compound B

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Desbutylbupivacaine, (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide, (RS)-N-(2,6-Dimethylphenyl)piperidine-2-carboxamide
• Formule empirique (notation de Hill): C₁₄H₂₀N₂O
• Numéro CAS: 15883-20-2
• Poids moléculaire : 232.32
• Numéro MDL: MFCD01701244
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0000088; traceable to USP 1078529
• Famille d'API: bupivacaine
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 20 mg
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-8°C
• Chaîne SMILES: O=C(NC1=C(C)C=CC=C1C)C2NCCCC2
• InChI: 1S/C14H20N2O/c1-10-6-5-7-11(2)13(10)16-14(17)12-8-3-4-9-15-12/h5-7,12,15H,3-4,8-9H2,1-2H3,(H,16,17)
• Clé InChI: SILRCGDPZGQJOQ-UHFFFAOYSA-N

Description

Description générale

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.
Bupivacaine Related Compound B is formed in the liver during oxidative dealkylation of bupivacaine hydrochloride and is the main metabolite of bupivacaine. It is a local anesthetic agent that can cross biological membranes due to its lipid-soluble nature.

Application

Bupivacaine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatographic and spectrophotometric techniques.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAA7918 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Informations sur la sécurité

• Pictogrammes: GHS06
• Mention d'avertissement: Danger
• Mentions de danger: H301
• Conseils de prudence: P301 + P330 + P331 + P310
• Classification des risques: Acute Tox. 3 Oral
• Code de la classe de stockage: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Classe de danger pour l'eau (WGK): WGK 1
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable