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Key Documents

PHR1851

Supelco

Olmesartan Medoxomil

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Olmesartan medoxomil

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About This Item

Empirical Formula (Hill Notation):
C29H30N6O6
CAS Number:
Molecular Weight:
558.59
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 1173
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

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

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)

InChI key

UQGKUQLKSCSZGY-UHFFFAOYSA-N

Gene Information

human ... AGTR1(185)

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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.

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.

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

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 LRAC2529 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

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

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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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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