PHR1729

Buprénorphine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Chlorhydrate de [5α,7α(S)]-17-(cyclopropylméthyl)-α-(1,1-diméthyléthyl)4,5-époxy-18,19-dihydo-3-hydroxy-6-méthoxy-α-méthyl-6,14-ethènomorphinane-7-méthanol
• Formule empirique (notation de Hill): C₂₉H₄₁NO₄ · HCl
• Numéro CAS: 53152-21-9
• Poids moléculaire : 504.10
• Numéro CE : 258-396-8
• Numéro MDL: MFCD00084836
• Code UNSPSC : 41116107
• ID de substance PubChem : 329823578
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0001109; traceable to USP 1078700
• Famille d'API: buprenorphine
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 50 mg
• Contrôle du médicament: USDEA Schedule III; regulated under CDSA - not available from Sigma-Aldrich Canada; psicótropo (Spain); Decreto Lei 15/93: Tabela IIC (Portugal)
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-30°C
• Chaîne 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
• Clé InChI: UAIXRPCCYXNJMQ-RZIPZOSSSA-N

Description

Description générale

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.

Application

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.

Actions biochimiques/physiologiques

Agoniste pur des récepteurs ORL1 ; antagoniste ou agoniste partiel des récepteurs opiacés μ, κ, et δ.

Remarque sur l'analyse

These secondary standards offer multi-traceability to the USP, EP 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 LRAA7438 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Informations sur la sécurité

• Pictogrammes: GHS08,GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H302,H361
• Conseils de prudence: P201 - P301 + P312 + P330 - P308 + P313
• Classification des risques: Acute Tox. 4 Oral - Repr. 2
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable