PHR2050

Amlodipine Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 3-Ethyl 5-methyl [2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylate] fumarate
• Empirical Formula (Hill Notation): C₂₀H₂₃ClN₂O₅ · C₄H₄O₄
• CAS Number: 2138811-33-1
• Molecular Weight: 522.93
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to USP 1029512
• API family: amlodipine
• CofA: current certificate can be downloaded
• packaging: pkg of 50 mg
• application(s): pharmaceutical small molecule
• format: neat
• storage temp.: 2-8°C

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.

It is an impurity of the long-acting calcium channel blocker, amlodipine, that belongs to the class of 1,4-Dihydropyridine (DHP) calcium antagonists. The parent active pharmaceutical ingredient is used in the treatment of hypertension and anginal chest pain.

Application

This pharmaceutical secondary standard can also be used as follows:

• Development of a stability-indicating reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method for determining related impurities of S(−)amlodipine and S(−)metoprolol succinate in their combined tablet dosage
• Ultra-high pressure liquid chromatographic (UHPLC) separation and estimation of amlodipine and bisoprolol-related impurities in the combined pharmaceutical formulation of the parent APIs
• Development and validation of a UHPLC method for quantifying impurities of valsartan, amlodipine besylate, and hydrochlorothiazide in their combined tablet dosage
• Separation and determination of amlodipine and atorvastatin, along with their impurities using a stability-indicating RP-HPLC method in their combined solid dosage forms

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 LRAB9841 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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Safety Information

• pictograms: GHS06,GHS08,GHS05,GHS09
• signalword: Danger
• hcodes: H301,H318,H373,H410
• pcodes: P260 - P273 - P280 - P301 + P310 - P305 + P351 + P338 - P314
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Eye Dam. 1 - STOT RE 2
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable