PHR1738

Bupivacaine Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinônimo(s): 6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide (Bupivacaine Related Compound A) (Bupivacaine Impurity E)
• Código UNSPSC: 41116107
• NACRES: NA.24

Propriedades

• grau: certified reference material; pharmaceutical secondary standard
• Nível de qualidade: 300
• Agency: traceable to Ph. Eur. Y0000089; traceable to USP 1078518
• família API: bupivacaine
• Certificado de análise (CofA): current certificate can be downloaded
• embalagem: pkg of 40 mg
• aplicação(ões): pharmaceutical (small molecule)
• Formato: neat
• temperatura de armazenamento: 2-8°C

Descrição

Descrição geral

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 and its derivatives are a category of compounds that are used as local anesthetics. Its applications consist of infiltration, nerve block, epidural, and intrathecal anesthesia.[1][2]

Aplicação

Bupivacaine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatographic[3] and spectrophotometric[4] 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.

Nota de análise

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

Outras notas

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 de rodapé

To see an example of a Certificate of Analysis for this material enter LRAA7909 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Informações de segurança

• Pictogramas: GHS06
• Palavra indicadora: Danger
• Frases de perigo: H301,H413
• Declarações de precaução: P273 - P301 + P310 + P330
• Classificações de perigo: Acute Tox. 3 Oral - Aquatic Chronic 4
• Código de classe de armazenamento: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Classe de risco de água (WGK): WGK 3
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable