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Documentos Principais

PHR1824

Supelco

Pramipexole Related Compound D

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Dexpramipexole dihydrochloride, (R)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride, (R)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride // (R)-Pramipexole dihydrochloride, (R)-4,5,6,7-Tetrahydro-6-(propylamino)-benzothiazole-2-amine dihydrochloride, (R)-Pramipexole dihydrochloride, KNS 760704, R-(+)-Pramipexole dihydrochloride, RPPX, SND 919CL2X

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About This Item

Fórmula empírica (Notação de Hill):
C10H17N3S · 2HCl
Número CAS:
Peso molecular:
284.25
Número MDL:
Código UNSPSC:
12352200
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to Ph. Eur. Y0001267
traceable to USP 1553815

descrição

Pharmaceutical Secondary Standard; Certified Reference Material

família API

pramipexole

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 50 mg

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

Formato

neat

temperatura de armazenamento

2-30°C

cadeia de caracteres SMILES

Cl.Cl.CCCN[C@@H]1CCc2nc(N)sc2C1

InChI

1S/C10H17N3S.2ClH/c1-2-5-12-7-3-4-8-9(6-7)14-10(11)13-8;;/h7,12H,2-6H2,1H3,(H2,11,13);2*1H/t7-;;/m1../s1

chave InChI

QMNWXHSYPXQFSK-XCUBXKJBSA-N

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Descrição geral

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. Pramipexole Related Compound D is a pharmaceutical impurity of pramipexole. Pramipexole is a non-ergot dopamine receptor agonist, widely used in the treatment of Parkinson′s disease.

Aplicação

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. Pramipexole may be used as a secondary pharma standard for the determination of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography and ultraviolet spectrophotometry technique.

Ações bioquímicas/fisiológicas

R-(+)-Pramipexole is a neuroprotective agent; weak non-ergoline dopamine agonist. R-(+)-Pramipexole has been found to have neuroprotective effects and is being investigated for treatment of ALS. It reduces mitochondrial reactive oxygen species (ROS) production, inhibits the activation of apoptotic pathways, and increase cell survival in response to a variety of neurotoxins and β-amyloid neurotoxicity. Compared to the S-(-) isomer, R-(+)-Pramipexole has much lower dopamine agonist activity.

Nota de análise

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

Outras notas

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.

Nota de rodapé

To see an example of a Certificate of Analysis for this material enter LRAA9409 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictogramas

Exclamation mark

Palavra indicadora

Warning

Frases de perigo

Declarações de precaução

Classificações de perigo

Acute Tox. 4 Oral

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Development and validation of a LC method for the determination of pramipexole using an experimental design
Srinubabu G, et al.
Chromatographia, 64(1-2), 95-100 (2006)

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