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PHR1824

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Pramipexole Related Compound D

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(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
Empirical Formula (Hill Notation):
C10H17N3S · 2HCl
CAS Number:
Molecular Weight:
284.25
MDL number:
UNSPSC Code:
12352200
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0001267
traceable to USP 1553815

description

Pharmaceutical Secondary Standard; Certified Reference Material

API family

pramipexole

CofA

current certificate can be downloaded

packaging

pkg of 50 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

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

InChI key

QMNWXHSYPXQFSK-XCUBXKJBSA-N

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General description

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.

Biochem/physiol Actions

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.

Analysis Note

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

Other Notes

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.

Footnote

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.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 4 Oral

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

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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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