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Key Documents

PHR2010

Supelco

Pramipexole Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

2,6-Diamino-4,5,6,7-tetrahydrobenzothiazole, (S)-4,5,6,7-TETRAHYDROBENZO THIAZOLE-2,6-DIAMINE

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About This Item

Empirical Formula (Hill Notation):
C7H11N3S
CAS Number:
Molecular Weight:
169.25
MDL number:
UNSPSC Code:
41116107

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to USP 1553768

API family

pramipexole

CofA

current certificate can be downloaded

packaging

pkg of 50 mg

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

N[C@H]1CCc2nc(N)sc2C1

InChI

1S/C7H11N3S/c8-4-1-2-5-6(3-4)11-7(9)10-5/h4H,1-3,8H2,(H2,9,10)/t4-/m0/s1

InChI key

DRRYZHHKWSHHFT-BYPYZUCNSA-N

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General description

Pramipexole Related Compound A is an impurity of pramipexole, which is an aminobenzothiazole compound and non-ergoline dopamine agonist widely used in the treatment of Parkinson′s disease (PD).
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 using liquid chromatography 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 LRAB4761 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

Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Pre?clinical studies of pramipexole: clinical relevance
Hubble PJ
European Journal of Neurology, 7(2000), 15-20 null
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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