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PHR1335

Labetalol Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Labetalol hydrochloride, 2-Hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C19H24N2O3 · HCl
CAS Number:
32780-64-6
Molecular Weight:
364.87
NACRES:
NA.24
PubChem Substance ID:
329823320
UNSPSC Code:
41116107
EC Number:
251-211-1
MDL number:
MFCD00057663

Key Documents

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Product Name

Labetalol Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C19H24N2O3.ClH/c1-13(7-8-14-5-3-2-4-6-14)21-12-18(23)15-9-10-17(22)16(11-15)19(20)24;/h2-6,9-11,13,18,21-23H,7-8,12H2,1H3,(H2,20,24);1H

InChI key

WQVZLXWQESQGIF-UHFFFAOYSA-N

SMILES string

Cl.CC(CCc1ccccc1)NCC(O)c2ccc(O)c(c2)C(N)=O

grade

certified reference material
pharmaceutical secondary standard

agency

USP 1356654

API family

labetalol

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

Gene Information

human ... ADRA1A(148), ADRA1B(147), ADRA1D(146), ADRA2A(150), ADRA2B(151), ADRA2C(152), ADRB1(153), ADRB2(154), ADRB3(155)

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Other Notes

To see an example of a Certificate of Analysis for this material enter LRAA1069 in the slot below. This is an example certificate only and may not be the lot that you receive.
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.

Analysis Note

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

Application

Labetalol Hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using spectrophotometric techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

General description

Labetalol Hydrochloride is an adrenergic α-receptor and β-receptor blocking agent, widely used in the treatment of hypertension. It is a sensitive drug and is used quantitatively especially in myocardial infarction and unstable angina, since it decreases blood pressure more rapidly than other beta blockers.
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.

pictograms

Health hazard
GHS08

signalword

Warning

hcodes

H361f

Hazard Classifications

Repr. 2

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

监管及禁止进口产品
This item has

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Determination of labetalol hydrochloride in drug formulations by spectrophotometry
Rahman N, et al.
J. Chin. Chem. Soc., 54(1), 185-196 (2007)
Determination of labetalol hydrochloride by kinetic spectrophotometry using potassium permanganate as oxidant
Rahman N, et al.
Journal of the Mexican Chemical Society, 55(2), 105-112 (2011)
Chitra Saran et al.
The Journal of pharmacology and experimental therapeutics (2021-11-20)
Drug-induced liver injury (DILI) is the leading cause of acute liver failure and a major concern in drug development. Altered bile acid homeostasis via inhibition of the bile salt export pump (BSEP) is one mechanism of DILI. Dasatinib, pazopanib and

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