PHR1824

Pramipexole Related Compound D

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(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
• Formule empirique (notation de Hill): C₁₀H₁₇N₃S · 2HCl
• Numéro CAS: 104632-27-1
• Poids moléculaire : 284.25
• Numéro MDL: MFCD13186799
• Code UNSPSC : 12352200
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0001267; traceable to USP 1553815
• Description: Pharmaceutical Secondary Standard; Certified Reference Material
• Famille d'API: pramipexole
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 50 mg
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-30°C
• Chaîne 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
• Clé InChI: QMNWXHSYPXQFSK-XCUBXKJBSA-N

Description

Description générale

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.

Application

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.

Actions biochimiques/physiologiques

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.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

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.

Informations sur la sécurité

• Pictogrammes: GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H302
• Conseils de prudence: P301 + P312 + P330
• Classification des risques: Acute Tox. 4 Oral
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable