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PHR1880

Supelco

Octreotide Acetate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Octreotide acetate salt

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About This Item

Empirical Formula (Hill Notation):
C49H66N10O10S2 · xC2H4O2
CAS Number:
79517-01-4
Molecular Weight:
1019.24 (free base basis)
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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

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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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, EP and BP primary standards, where they are available.

Footnote

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.

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD8297
LRAC6386
LRAB1954
LRAC3014

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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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