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Key Documents

PHR1880

Supelco

醋酸奥曲肽

Pharmaceutical Secondary Standard; Certified Reference Material

同義詞:

Octreotide acetate salt

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About This Item

經驗公式(希爾表示法):
C49H66N10O10S2 · xC2H4O2
CAS號碼:
分子量::
1019.24 (free base basis)
分類程式碼代碼:
41116107
NACRES:
NA.24

等級

certified reference material
pharmaceutical secondary standard

品質等級

agency

traceable to USP 1477604

API 家族

octreotide

形狀

powder

CofA

current certificate can be downloaded

包裝

pkg of 10 mg

應用

pharmaceutical

儲存溫度

-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

InChI 密鑰

QWFYIFWTVZFPRY-AARKYNAGSA-N

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一般說明

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.

應用

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

分析報告

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

腳註

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.

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


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分析證明 (COA)

Lot/Batch Number

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存取文件庫

A simple stability indicating CZE method for the analysis of octreotide acetate
Tamizi E and Jouyban A
Chromatographia, 77, 1347-1357 (2014)

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