Merck
CN

PHR2050

Supelco

氨氯地平相关化合物A

Pharmaceutical Secondary Standard; Certified Reference Material

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别名:
3-Ethyl 5-methyl [2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylate] fumarate
经验公式(希尔记法):
C20H23ClN2O5 · C4H4O4
分子量:
522.93

等级

certified reference material
pharmaceutical secondary standard

质量水平

Agency

traceable to USP 1029512

API family

amlodipine

CofA

current certificate can be downloaded

包装

pkg of 50 mg

格式

neat

储存温度

2-8°C

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一般描述

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.

应用

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

分析说明

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

附注

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.

推荐产品

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

相关产品

产品编号
说明
价格

警示用语:

Danger

危险分类

Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Eye Dam. 1 - STOT RE 2

储存分类代码

6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable


分析证书(COA)

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示例

T1503
货号
-
25G
包装规格/数量

其它示例:

705578-5MG-PW

PL860-CGA/SHF-1EA

MMYOMAG-74K-13

1000309185

输入内容 1.000309185)

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批号可以在产品标签上"批“ (Lot或Batch)字后面找到。

Aldrich 产品

  • 如果您查询到的批号为 TO09019TO 等,请输入去除前两位字母的批号:09019TO。

  • 如果您查询到的批号含有填充代码(例如05427ES-021),请输入去除填充代码-021的批号:05427ES。

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部分情况下,可能未在线提供COA。如果搜索不到COA,可在线索取。

索取COA

Stability-indicating method for the determination of assay and quantification of impurities in amlodipine-atorvastatin combination dosage form by RP-HPLC
Sangeetha D and Vadlamudi MK
Journal of Liquid Chromatography and Related Technologies, 40, 576-598 (2017)
Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Determination of Related Substances of S (-) Amlodipine and S (-) Metoprolol Succinate in Fixed Dose Combination Tablet Dosage Form
Shitole S, et al.
Chromatography Research International, 2014 (2014)
Robust UHPLC separation method development for multi-API product containing amlodipine and bisoprolol: the impact of column selection
Kormany, R, et al.
Chromatographia, 77, 1119-1127 (2014)

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