PHR1880

オクトレオチド 酢酸塩

Pharmaceutical Secondary Standard; Certified Reference Material

• 別名: Octreotide acetate salt
• 実験式（ヒル表記法）: C₄₉H₆₆N₁₀O₁₀S₂ · xC₂H₄O₂
• CAS番号: 79517-01-4
• 分子量: 1019.24 (free base basis)
• UNSPSCコード: 41116107
• NACRES: NA.24

特性

• グレード: certified reference material; pharmaceutical secondary standard
• 品質水準: 300
• 認証: traceable to USP 1477604
• APIファミリー: octreotide
• フォーム: powder
• CofA: current certificate can be downloaded
• 包装: pkg of 10 mg
• アプリケーション: pharmaceutical
• 保管温度: -10 to -25°C
• SMILES記法: S1SCC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C1)C(=O)N[C@@H]([C@H](O)C)CO)C(O)C)CCCCN)Cc4c5c([nH]c4)cccc5)Cc3ccccc3)NC(=O)C(N)Cc2ccccc2.OC(=O)C.OC(=O)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
• InChI Key: QWFYIFWTVZFPRY-AARKYNAGSA-N

詳細

詳細

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.

アプリケーション

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

アナリシスノート

このような2次標準は、入手可能な場合にはUSP、EP、BPの1次標準にマルチトレーサビリティを提供します。

脚注

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.

安全性情報

• 保管分類コード: 11 - Combustible Solids
• WGK: WGK 3
• 引火点(°F): Not applicable
• 引火点(℃): Not applicable