Valganciclovir EP Impurity N (Hydrochloride) 1401562-16-0

Name: Valganciclovir EP Impurity N (Hydrochloride)
Brand: Vaqora Chemicals
SKU: VQ-006754

About Valganciclovir EP Impurity N (Hydrochloride)

Listed under CAS 1401562-16-0, Valganciclovir EP Impurity N (Hydrochloride) is a pharmacopeial impurity of Valganciclovir available from Vaqora Chemicals at a purity of 93%. Formula C15H25ClN6O5, molecular weight 404.85 g/mol. Alternative names: N-Methyl Valganciclovir Hydrochloride and Ganciclovir EP Impurity N (Hydrochloride).

The product is provided as a solid. Keep the vial tightly closed, protected from light and humidity, at the temperature stated on the Certificate of Analysis. The GHS classification uses the signal word “Danger”, so appropriate gloves, eye protection and ventilation are recommended.

Pharmaceutical QC and development laboratories use this impurity standard of Valganciclovir to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Buyers come mainly from pharmaceutical manufacturing and academic and industrial research.

We offer Valganciclovir EP Impurity N (Hydrochloride) in 10 mg, 25 mg, 50 mg and 100 mg packs with a batch-specific COA, and ship to customers worldwide. Stock is available for quick dispatch.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Valganciclovir

View every impurity, metabolite and intermediate we list for Valganciclovir.

Valganciclovir impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Valganciclovir EP Impurity N (Hydrochloride)
Catalogue No.	VQ-006754
CAS Number	1401562-16-0
Other CAS	1401661-95-7
IUPAC name	[2-[(2-amino-6-oxo-1H-purin-9-yl)methoxy]-3-hydroxypropyl] (2S)-3-methyl-2-(methylamino)butanoate;hydrochloride
Molecular formula	C₁₅H₂₅ClN₆O₅
Molecular weight	404.85 g/mol
Exact mass	404.1575
Grade	Reference Standard
Purity / assay	93%
HSN code	38229090
InChIKey	UOXYIRLWWGUICN-FTCYEJDNSA-N
SMILES	CC(C)[C@@H](C(=O)OCC(CO)OCN1C=NC2=C1N=C(NC2=O)N)NC.Cl
PubChem CID	137177902

Physical properties
Physical form	Solid
H-bond donors / acceptors	5 / 8
TPSA	153 Å²
Synonyms	N-Methyl Valganciclovir Hydrochloride, Ganciclovir EP Impurity N (Hydrochloride), Ganciclovir Impurity N, Ganciclovir Mono-N-methyl Valinate Hydrochloride, Valganciclovir Impurity 4, N-Methyl Valganciclovir Hydrochloride (Mixture of Diastereomers), Valganciclovir Impurity 5, Valganciclovir EP Impurity N, (2-(RS)-[(guanin-9-yl)methoxy]-3-hydroxypropyl N-methyl-L-valinate hydrochloride), 2-(RS)-[(Guanin-9-yl)methoxy]-3-hydroxypropyl N-methyl-L-valinate hydrochloride

Safety & hazard information (GHS)

Health hazard

Signal word: Danger

Hazard statements

H340May cause genetic defects

Precautionary statements: P203, P280, P318, P405, P501

Classification is indicative (aggregated GHS notifications) and may vary by grade and concentration. Always refer to the SDS supplied with your lot.

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Valganciclovir EP Impurity N (Hydrochloride)?

The CAS Registry Number of Valganciclovir EP Impurity N (Hydrochloride) is 1401562-16-0. It is also known as N-Methyl Valganciclovir Hydrochloride, Ganciclovir EP Impurity N (Hydrochloride), Ganciclovir Impurity N.

What is the molecular formula and molecular weight of Valganciclovir EP Impurity N (Hydrochloride)?

Valganciclovir EP Impurity N (Hydrochloride) has the molecular formula C15H25ClN6O5 and a molecular weight of 404.85 g/mol.

What is Valganciclovir EP Impurity N (Hydrochloride) used for?

Valganciclovir EP Impurity N (Hydrochloride) is supplied as a characterised reference material related to Valganciclovir. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Valganciclovir EP Impurity N (Hydrochloride) can I order?

We supply Valganciclovir EP Impurity N (Hydrochloride) in Reference Standard (93%) grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Valganciclovir EP Impurity N (Hydrochloride)?

Yes. Every lot of Valganciclovir EP Impurity N (Hydrochloride) is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Valganciclovir EP Impurity N (Hydrochloride) be shipped internationally?

Yes. Valganciclovir EP Impurity N (Hydrochloride) is classified as hazardous, so it is packed in UN-approved packaging and shipped as dangerous goods under IATA/IMDG rules. We export worldwide on EXW, FOB, CIF and DAP terms.