Impurity reference standards
Pramipexole impurity standards
34 characterised compounds linked to Pramipexole are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 11 pharmacopoeial impurities, 1 nitrosamine and 2 degradation products.
34reference materials
11pharmacopoeial
1nitrosamines
2degradants
Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Pharmacopoeial11EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Degradants2N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Pramipexole reference materials
1–34 of 34 standards
(S)-N6,N6-dipropyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine
- CAS
- 1147937-31-2
- Formula
- C8H10N4O3S
- MW
- 242.26 g/mol
ZX-026475
2-Amino-6-phthalimido-4,5,6,7-tetrahydrobenzothiazole
- CAS
- 104618-33-9
- Formula
- C15H13N3O2S
- MW
- 299.3 g/mol
ZX-031937
N-(2-Amino-4,5,6,7-tetrahydro-1,3-benzothiazol-6-yl)acetamide
- CAS
- 104617-51-8
- Formula
- C9H13N3OS
- MW
- 211.29 g/mol
ZX-031941
N-(Aminothioxomethyl)-5-oxo-1-propyl-2-pyrrolidineacetamide
- CAS
- 936751-11-0
- Formula
- C10H17N3O2S
- MW
- 243.33 g/mol
ZX-031938
Pramipexole EP Impurity A (DiHydrochloride Salt)
- CAS
- 106092-10-8
- Formula
- C7H13Cl2N3S
- MW
- 242.17 g/mol
ZX-005895
Pramipexole EP Impurity B (Dihydrochloride Salt)
- CAS
- 1802051-36-0
- Formula
- C13H25Cl2N3S
- MW
- 326.3 g/mol
ZX-005896
Pramipexole EP impurity D (DiHydrochloride Salt)
- CAS
- 104632-27-1
- Formula
- C10H19Cl2N3S
- MW
- 284.2 g/mol
ZX-005898
rac N-Propyl-2-cyanimidopyrrolidine-5-acetic Acid
- CAS
- 1246833-75-9
- Formula
- C10H15N3O2
- MW
- 209.24 g/mol
ZX-031939
Questions
Pramipexole impurities, answered
How many Pramipexole impurity standards does Zemixal list?
The catalogue currently lists 34 compounds for Pramipexole, including 11 pharmacopoeial impurities, 1 nitrosamine and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Pramipexole impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Pramipexole impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
Do you supply Pramipexole nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Pramipexole. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.