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Documentos Principais

PHR1729

Supelco

Buprenorphine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Buprenorphine hydrochloride, [5α,7α(S)]-17-(Cyclopropylmethyl)-α-(1,1-dimethylethyl)4,5-epoxy-18,19-dihydo-3-hydroxy-6-methoxy-α-methyl-6,14-ethenomorphinan-7-methanol hydrochloride

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About This Item

Fórmula empírica (Notação de Hill):
C29H41NO4 · HCl
Número CAS:
Peso molecular:
504.10
Número CE:
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to Ph. Eur. Y0001109
traceable to USP 1078700

família API

buprenorphine

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 50 mg

controle de medicamentos

USDEA Schedule III; regulated under CDSA - not available from Sigma-Aldrich Canada; psicótropo (Spain); Decreto Lei 15/93: Tabela IIC (Portugal)

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

Formato

neat

temperatura de armazenamento

2-30°C

cadeia de caracteres SMILES

Cl[H].CO[C@]12CC[C@@]3(C[C@@H]1[C@](C)(O)C(C)(C)C)[C@H]4Cc5ccc(O)c6O[C@@H]2[C@]3(CCN4CC7CC7)c56

InChI

1S/C29H41NO4.ClH/c1-25(2,3)26(4,32)20-15-27-10-11-29(20,33-5)24-28(27)12-13-30(16-17-6-7-17)21(27)14-18-8-9-19(31)23(34-24)22(18)28;/h8-9,17,20-21,24,31-32H,6-7,10-16H2,1-5H3;1H/t20-,21-,24-,26+,27-,28+,29-;/m1./s1

chave InChI

UAIXRPCCYXNJMQ-RZIPZOSSSA-N

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Descrição geral

Certified 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.
Buprenorphine Hydrochloride is a potent long-acting synthetic opiate analgesic.

Aplicação

Buprenorphine Hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by high performance liquid chromatography method.
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.

Ações bioquímicas/fisiológicas

Agonist at ORL1 receptors; antagonist or partial agonist at μ, κ, and δ opioid receptors.
Full agonist at ORL1 receptors, antagonist or partial agonist at μ, κ, and δ opioid receptors.

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 LRAA7438 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictogramas

Health hazardExclamation mark

Palavra indicadora

Warning

Frases de perigo

Declarações de precaução

Classificações de perigo

Acute Tox. 4 Oral - Repr. 2

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Certificados de análise (COA)

Lot/Batch Number

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Visite a Biblioteca de Documentos

Development and validation of a HPLC method for the determination of buprenorphine hydrochloride, naloxone hydrochloride and noroxymorphone in a tablet formulation
Mostafavi A, et al.
Talanta, 77(4), 1415-1419 (2009)
The respiratory depressive effects of intravenous buprenorphine in patients in an intensive care unit.
Downing JW, et al.
South African Medical Journal = Suid-Afrikaanse Tydskrif Vir Geneeskunde, 55(25), 1023-1027 (1979)

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