PHR1598

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
• Empirical Formula (Hill Notation): C₁₀H₁₇N₃S · 2HCl · H₂O
• CAS Number: 191217-81-9
• Molecular Weight: 302.26
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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

Description

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

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Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H302,H336
• Precautionary Statements: P261 - P264 - P271 - P301 + P312 - P304 + P340 + P312 - P403 + P233
• 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