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Merck
CN

PHR1851

奥美沙坦酯

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

Olmesartan medoxomil

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关于此项目

经验公式（希尔记法）:
C29H30N6O6
化学文摘社编号:
144689-63-4
分子量:
558.59
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
MFCD00944911

主要文件

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产品名称

奥美沙坦酯, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C29H30N6O6/c1-5-8-23-30-25(29(3,4)38)24(27(36)39-16-22-17(2)40-28(37)41-22)35(23)15-18-11-13-19(14-12-18)20-9-6-7-10-21(20)26-31-33-34-32-26/h6-7,9-14,38H,5,8,15-16H2,1-4H3,(H,31,32,33,34)

SMILES string

CCCC1=NC(C(O)(C)C)=C(C(OCC2=C(C)OC(O2)=O)=O)N1CC(C=C3)=CC=C3C4=CC=CC=C4C5=NN=NN5

InChI key

UQGKUQLKSCSZGY-UHFFFAOYSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001405
traceable to USP 1478367

API family

olmesartan

CofA

current certificate can be downloaded

packaging

pkg of 200 mg

application(s)

pharmaceutical

format

neat

storage temp.

-10 to -25°C

Quality Level

300

Gene Information

human ... AGTR1(185)

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Analysis Note

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

Application

Theis pharmaceutical secondary standard can also be used as follows:

  • Development and validation of an isocratic ultra-high performance liquid chromatography (UHPLC) based stability indicating method to determine olmesartan medoxomil and amlodipine besylate in combined tablet dosage forms
  • Simultaneous determination of Olmesartan medoxomil and chlorthalidone by reversed phase-high performance liquid chromatography (RP-HPLC) in tablets
  • Quantification of olmesartan medoxomil and its degradation products in bulk drugs and pharmaceutical formulations by using a systematic quality by design (QbD)-based reverse-phase liquid chromatography method
  • Reversed phase-high performance liquid chromatographic (RP-HPLC) analysis of olmesartan medoxomil and hydrochlorothiazide in their combined tablet dosage form
  • Determination of olmesartan medoxomil and amlodipine besylate in their combined tablet dosage form by absorption subtraction method, ratio subtraction with extended ratio subtraction method, dual wavelength technique, and second order derivative spectrophotometry

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.

Olmesartan Medoxomil is an AT1 subtype angiotensin-II receptor antagonist used in the management of hypertension. It prevents angiotensin II from binding to the AT1 receptors, thereby decreasing vasoconstriction.

Other Notes

To see an example of a Certificate of Analysis for this material enter LRAC2529 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation mark
GHS07

signalword

Warning

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

分析证书(COA)

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Development and validation of RP-HPLC method for the simulteneous estimation of olmesartan medoxomil and chlorthalidone in tablet dosage form
Sawale V, et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 7, 266-269 (2015)
DAD based stability indicating RP-UPLC method for simultaneous determination of olmesartan medoxomil and amlodipine besylate
Kerai JR, et al.
Pharmaceutical Chemistry Journal, 52, 959-964 (2019)
Development and validation of RP-HPLC method for simultaneous determination of a combined formulation of olmesartan medoxomil & hydrochlorothiazide
Sony A, et al.
World Journal of Pharmacy and Pharmaceutical Sciences, 9, 1468-1488 (2020)

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