PHR1851

Olmesartan Medoxomil

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Olmesartan medoxomil
• Empirical Formula (Hill Notation): C₂₉H₃₀N₆O₆
• CAS Number: 144689-63-4
• Molecular Weight: 558.59
• MDL number: MFCD00944911
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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)

Description

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.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H302 + H312 + H332
• Precautionary Statements: P261 - P264 - P280 - P301 + P312 - P302 + P352 + P312 - P304 + P340 + P312
• 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