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Merck
CN

PHR1880

醋酸奥曲肽

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

Octreotide acetate salt

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关于此项目

经验公式(希尔记法):
C49H66N10O10S2 · xC2H4O2
化学文摘社编号:
分子量:
1019.24 (free base basis)
UNSPSC Code:
41116107
NACRES:
NA.24
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SMILES string

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

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1477604

API family

octreotide

form

powder

CofA

current certificate can be downloaded

packaging

pkg of 10 mg

application(s)

pharmaceutical

storage temp.

-10 to -25°C

Quality Level

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General description

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.

Application

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

Analysis Note

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

Other Notes

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.

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

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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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