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Merck
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Key Documents

PHR1880

Supelco

Octreotide Acetate

Pharmaceutical Secondary Standard; Certified Reference Material

동의어(들):

Octreotide acetate salt

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About This Item

실험식(Hill 표기법):
C49H66N10O10S2 · xC2H4O2
CAS Number:
Molecular Weight:
1019.24 (free base basis)
UNSPSC 코드:
41116107
NACRES:
NA.24

Grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to USP 1477604

API family

octreotide

형태

powder

CofA

current certificate can be downloaded

포장

pkg of 10 mg

응용 분야

pharmaceutical

저장 온도

-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 key

QWFYIFWTVZFPRY-AARKYNAGSA-N

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일반 설명

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.

애플리케이션

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

분석 메모

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

각주

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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point (°F)

Not applicable

Flash Point (°C)

Not applicable


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시험 성적서(COA)

Lot/Batch Number

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이 제품을 이미 가지고 계십니까?

문서 라이브러리에서 최근에 구매한 제품에 대한 문서를 찾아보세요.

문서 라이브러리 방문

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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