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Documenti fondamentali

PHR1729

Supelco

Buprenorphine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

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

Formula empirica (notazione di Hill):
C29H41NO4 · HCl
Numero CAS:
Peso molecolare:
504.10
Numero CE:
Numero MDL:
Codice UNSPSC:
41116107
ID PubChem:
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to Ph. Eur. Y0001109
traceable to USP 1078700

Famiglia di API

buprenorphine

CdA

current certificate can be downloaded

Confezionamento

pkg of 50 mg

Controllo stupefacenti

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

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

2-30°C

Stringa SMILE

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
UAIXRPCCYXNJMQ-RZIPZOSSSA-N

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Descrizione generale

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.

Applicazioni

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.

Azioni biochim/fisiol

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.

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

Pittogrammi

Health hazardExclamation mark

Avvertenze

Warning

Indicazioni di pericolo

Classi di pericolo

Acute Tox. 4 Oral - Repr. 2

Codice della classe di stoccaggio

11 - Combustible Solids

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

Lot/Batch Number

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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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