PHR1880

Octreotide Acetate

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinonimo/i: Octreotide acetate salt
• Formula empirica (notazione di Hill): C₄₉H₆₆N₁₀O₁₀S₂ · xC₂H₄O₂
• Numero CAS: 79517-01-4
• Peso molecolare: 1019.24 (free base basis)
• Codice UNSPSC: 41116107
• NACRES: NA.24

Proprietà

• Grado: certified reference material; pharmaceutical secondary standard
• Livello qualitativo: 300
• agenzia: traceable to USP 1477604
• Famiglia di API: octreotide
• Forma fisica: powder
• CdA: current certificate can be downloaded
• Confezionamento: pkg of 10 mg
• applicazioni: pharmaceutical
• Temperatura di conservazione: -10 to -25°C
• InChI: 1S/C49H66N10O10S2.2C2H4O2/c1-28(61)39(25-60)56-48(68)41-27-71-70-26-40(57-43(63)34(51)21-30-13-5-3-6-14-30)47(67)54-37(22-31-15-7-4-8-16-31)45(65)55-38(23-32-24-52-35-18-10-9-17-33(32)35)46(66)53-36(19-11-12-20-50)44(64)59-42(29(2)62)49(69)58-41;2*1-2(3)4/h3-10,13-18,24,28-29,34,36-42,52,60-62H,11-12,19-23,25-27,50-51H2,1-2H3,(H,53,66)(H,54,67)(H,55,65)(H,56,68)(H,57,63)(H,58,69)(H,59,64);2*1H3,(H,3,4)/t28-,29?,34?,36?,37?,38?,39-,40?,41?,42?;;/m1../s1; QWFYIFWTVZFPRY-AARKYNAGSA-N

Descrizione

Descrizione generale

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.

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.

Octreotide belongs to the group of synthetic cyclic octapeptides, known for its selectivity towards inhibiting the growth hormone. It binds to the somatostatin receptor 2 (SSTR2), and thereby prevents the secretion pathways of growth hormone. Hence it is used in the treatment of diseases caused by overproduction of growth hormone, such as acromegaly.

Applicazioni

This pharmaceutical secondary standard can also be used as follows:

• Octreotide acetate analysis of amino acids including hydrolysis, derivatization of released amino acids with 4-N,N-dimethylaminoazobenzene-4ʹ-sulfonyl chloride (DABS-Cl), and finally their reversed phase-high performance liquid chromatography (RP-HPLC) determination
• Development of a quantitative nuclear magnetic resonance (1H-qNMR) based method for the estimation of octreotide acetate in bulk drug
• Determination of octreotide acetate in pharmaceutical formulations using a stability-indicating capillary zone electrophoresis method (CZE)
• Estimation of octreotide acetate from a peptide-based hydrogel using an ultra-high performance liquid chromatographic method in combination with photo-diode array detection (PDA), following the quality-by-design (QbD) approach

Risultati analitici

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

Nota a piè di pagina

To see an example of a Certificate of Analysis for this material enter LRAC3014 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Informazioni sulla sicurezza

• 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