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Key Documents

PHR1756

Supelco

Bupivacaine Related Compound B

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

Desbutylbupivacaine, (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide, (RS)-N-(2,6-Dimethylphenyl)piperidine-2-carboxamide

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About This Item

Formula empirica (notazione di Hill):
C14H20N2O
Numero CAS:
Peso molecolare:
232.32
Numero MDL:
Codice UNSPSC:
41116107
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to Ph. Eur. Y0000088
traceable to USP 1078529

Famiglia di API

bupivacaine

CdA

current certificate can be downloaded

Confezionamento

pkg of 20 mg

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

2-8°C

Stringa SMILE

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)
SILRCGDPZGQJOQ-UHFFFAOYSA-N

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Descrizione generale

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.

Applicazioni

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.

Risultati analitici

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

Altre note

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.

Nota a piè di pagina

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.

Prodotti correlati

Pittogrammi

Skull and crossbones

Avvertenze

Danger

Indicazioni di pericolo

Consigli di prudenza

Classi di pericolo

Acute Tox. 3 Oral

Codice della classe di stoccaggio

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Classe di pericolosità dell'acqua (WGK)

WGK 1

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

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Determination of tramadol, metamizole, ropivacaine, and bupivacaine in analgesic mixture samples by HPLC with DAD detection
Salmeron-Garcia A, et al.
Journal of Chromatographic Science, 47(3), 231-237 (2009)
Simultaneous determination of bupivacaine and its two metabolites, desbutyl-and 4′-hydroxybupivacaine, in human serum and urine
Lindberg RLP, et al
Journal of Chromatography. B, Biomedical Sciences and Applications, 383, 357-364 (1986)
Quantitative mass spectrometric analysis of ropivacaine and bupivacaine in authentic, pharmaceutical and spiked human plasma without chromatographic separation
Salama NN and Wang S
Analytical Chemistry Insights, 4(3), ACI-S2564 (2009)

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