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Key Documents

PHR1598

Supelco

Pramipexole Dihydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Pramipexole dihydrochloride monohydrate, (S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride

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About This Item

Empirical Formula (Hill Notation):
C10H17N3S · 2HCl · H2O
CAS Number:
Molecular Weight:
302.26
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0001266
traceable to USP 1553859

API family

pramipexole

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

InChI

1S/C10H17N3S.2ClH.H2O/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;1H2/t7-;;;/m0.../s1

InChI key

APVQOOKHDZVJEX-QTPLPEIMSA-N

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General description

Pramipexole Dihydrochloride is a non-ergot dopamine agonist widely used for the treatment of early and advanced Parkinson′s disease (PD). It is also used to treat restless legs syndrome.
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.

Application

Pramipexole Dihydrochloride may be used as a secondary pharma standard for the determination of the analyte in pharmaceutical formulations by spectrophotometric technique.
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.

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 LRAA4714 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - STOT SE 3

Target Organs

Central nervous system

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Ecofriendly spectrophotometric method development and their validation for quantitative estimation of Pramipexole Dihyrochloride using mixed hydrotropic agent
Jain N, et al.
Journal of Chemical and Pharmaceutical Research , 3(1), 548-552 (2009)
Spectrophotometric methods for the estimation of pramipexole dihydrochloride in pharmaceutical formulations
Gurupadayya MB, et al.
World Journal of chemistry, 4(2), 157-160 (2009)

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