impuritylab.com

Peramivir Impurity N1

process impurity reference standard

CAS229613-93-8
Peramivir Impurity N1 chemical structure
Cat. no. CP128742 Purity >95% HPLC Form Off-White to Beige Solid

Specifications

Product name
Peramivir Impurity N1
CAS number
229613-93-8
Catalogue number
CP128742
Molecular formula
C18H30N2O5
Molecular weight
354.44
Purity (HPLC)
>95%
Physical form
Off-White to Beige Solid
Storage
2-8 °C
SMILES
O1N=C(C(CC)CC)[C@@H]2[C@H]1[C@H](C[C@H]2NC(OC(C)(C)C)=O)C(OC)=O
Available pack sizes
Quoted on request
Lead time
In stock
Intended use
Related substances and impurity testing, method development and validation, system suitability, QC release and stability testing.

Fields shown as — are not published for this item. They are left blank rather than filled with an estimate.

Description

Peramivir Impurity N1 (CAS 229613-93-8) is supplied by ImpurityLab as a process impurity standard, covering impurities that are neither pharmacopoeially lettered nor degradation products of the parent substance. Catalogue number CP128742. It is related to Peramivir.

Parent drug substance. Peramivir. Browse the full Peramivir impurity and related compound standards held by ImpurityLab.

The material is issued against molecular formula C18H30N2O5, molecular weight 354.44 g mol−1, physical form described as off-white to beige solid.

Structural notation: O1N=C(C(CC)CC)[C@@H]2[C@H]1[C@H](C[C@H]2NC(OC(C)(C)C)=O)C(OC)=O

Process impurities are controlled through the ICH Q3A reporting, identification and qualification thresholds, or through the equivalent thresholds in ICH Q3B for the drug product. The limits depend on the maximum daily dose of the product rather than on the impurity itself.

Storage. Store at 2-8 °C. Allow the container to reach room temperature before opening so that moisture does not condense onto the material. Record the date of first opening on the label.

Pack sizes. Quoted on request. Non-standard quantities are quoted on request, normally within two working days.

Documentation. Each lot is released with a certificate of analysis that states the assay method, the water content and the form as supplied. The safety data sheet is available with the same lot number. Quote catalogue number CP128742 when requesting either document.

Documentation

Certificate of analysis (per lot)COA-CP128742Download
Safety data sheet (SDS)SDS-CP128742Download

Documents are issued per lot. The COA you receive describes the lot that ships, not a representative sample.

Regulatory reference

Process impurity, not pharmacopoeially lettered. Set the limit from your own ICH Q3A or Q3B assessment and confirm against the current method.

References are provided to help you map a standard to a pharmacopoeial method. Confirm the acceptance criteria against your own method before use.

Processed in 0.372207 Second , 115 querys.