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Key Documents

PHR1128

Supelco

Bupivacaine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Bupivacaine hydrochloride monohydrate, 1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide

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About This Item

Formule empirique (notation de Hill):
C18H28N2O · HCl · H2O
Numéro CAS:
Poids moléculaire :
342.90
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to BP 479
traceable to Ph. Eur. B1160000
traceable to USP 1078507

Famille d'API

bupivacaine

CofA (certificat d'analyse)

current certificate can be downloaded

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-30°C

Chaîne SMILES 

O.Cl.CCCCN1CCCCC1C(=O)Nc2c(C)cccc2C

InChI

1S/C18H28N2O.ClH.H2O/c1-4-5-12-20-13-7-6-11-16(20)18(21)19-17-14(2)9-8-10-15(17)3;;/h8-10,16H,4-7,11-13H2,1-3H3,(H,19,21);1H;1H2

Clé InChI

HUCIWBPMHXGLFM-UHFFFAOYSA-N

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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.

Application

Bupivacaine hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometry and high performance liquid chromatography methods.
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.

Actions biochimiques/physiologiques

Sodium channel blocker, local anesthetic.

Remarque sur l'analyse

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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 LRAA6762 in the slot below. This is an example certificate only and may not be the lot that you receive.

Produits recommandés

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.

Pictogrammes

Skull and crossbones

Mention d'avertissement

Danger

Mentions de danger

Classification des risques

Acute Tox. 1 Inhalation - Acute Tox. 2 Dermal - Acute Tox. 2 Oral

Code de la classe de stockage

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

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Consulter la Bibliothèque de documents

Spectrophotometric method for determination of bupivacaine hydrochloride in pharmaceutical preparations
Corciova A
European Chemical Bulletin, 2(8), 554-557 (2013)
Development and validation of an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions.
Piekarski M, et al.
European Journal of Hospital Pharmacy-Science and Practice, 19(5), 447-451 (2012)
Vladimir Kharitonov
Postgraduate medicine, 126(1), 129-138 (2014-01-08)
The compatibility of a medication with other drugs and implanted materials is an important factor impacting drug safety and efficacy. The liposomal formulation of the local anesthetic bupivacaine is designed to provide prolonged postsurgical analgesia. Its compatibility with other drugs
Kejian Shi et al.
Anesthesia and analgesia, 116(4), 804-809 (2013-03-06)
While lipid emulsion may reverse the systemic toxicity of bupivacaine, the pharmacokinetics and tissue distribution of bupivacaine after lipid emulsion infusion are not clear. In this study, we assessed the influence of lipid emulsion administration on the pharmacokinetics and tissue
Brian M Ilfeld et al.
Anesthesia and analgesia, 117(5), 1248-1256 (2013-10-11)
Currently available local anesthetics approved for single-injection peripheral nerve blocks have a maximum duration of <24 hours. A liposomal bupivacaine formulation (EXPAREL, Pacira Pharmaceuticals, Inc., San Diego, CA), releasing bupivacaine over 96 hours, recently gained Food and Drug Administration approval

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