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主要文件

安全信息

PHR1880

Supelco

醋酸奥曲肽

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

Octreotide acetate salt

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About This Item

经验公式（希尔记法）:
C49H66N10O10S2 · xC2H4O2
CAS号:
79517-01-4
分子量:
1019.24 (free base basis)
UNSPSC代码:
41116107
NACRES:
NA.24

等级

certified reference material
pharmaceutical secondary standard

质量水平

300

Agency

traceable to USP 1477604

API类

octreotide

表单

powder

CofA

current certificate can be downloaded

包装

pkg of 10 mg

应用

pharmaceutical

储存温度

-10 to -25°C

SMILES字符串

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

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一般描述

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.

应用

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

分析说明

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

附注

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.

储存分类代码

11 - Combustible Solids

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable

法规信息

监管及禁止进口产品

历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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A simple stability indicating CZE method for the analysis of octreotide acetate
Tamizi E and Jouyban A
Chromatographia, 77, 1347-1357 (2014)
Quantitative determination and validation of octreotide acetate using 1H-NMR spectroscopy with internal standard method
Yu C, et al.
Magnetic Resonance in Chemistry, 56, 37-45 (2018)

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