Nizatidine EP Impurity A

About Nizatidine EP Impurity A

Nizatidine EP Impurity A is a pharmacopeial impurity of Nizatidine carrying the CAS registry number 54252-45-8 at a purity of 99.46%. Formula C4H9N3O2, molecular weight 131.13 g/mol. The IUPAC name is 1-N,1-N'-dimethyl-2-nitroethene-1,1-diamine. It is also known as N,N'-Dimethyl-2-nitro-1,1-ethenediamine or 1,1-Bis(methylamino)-2-nitroethene.

It is supplied 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 Nizatidine 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 Nizatidine EP Impurity A 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 Nizatidine

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

Nizatidine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Nizatidine EP Impurity A
Catalogue No.	VQ-006543
CAS Number	54252-45-8
IUPAC name	1-N,1-N'-dimethyl-2-nitroethene-1,1-diamine
Molecular formula	C₄H₉N₃O₂
Molecular weight	131.13 g/mol
Exact mass	131.0695
Grade	Reference Standard
Purity / assay	99.46%
HSN code	38229090
InChIKey	VQBVPDAUEBSGMB-UHFFFAOYSA-N
SMILES	CNC(=C[N+](=O)[O-])NC
PubChem CID	12377312

Physical properties
Physical form	Solid
LogP (XLogP3)	0.5
H-bond donors / acceptors	2 / 4
TPSA	69.9 Å²
Synonyms	N,N'-Dimethyl-2-nitro-1,1-ethenediamine, 1,1-Bis(methylamino)-2-nitroethene, N,N'-Dimethyl-2-nitroethene-1,1-diamine, Ranitidine EP Impurity L, 1,1-Ethenediamine, N,N'-dimethyl-2-nitro-, Nizatidine Impurity A, N,N'-Dimethyl-2-nitro-1,1-ethendiamine, N~1~,N'~1~-Dimethyl-2-nitroethene-1,1-diamine, Nizatidine Imp. A (EP)

Safety & hazard information (GHS)

Health hazard

Signal word: Danger

Hazard statements

H360May damage fertility or the unborn child

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 Nizatidine EP Impurity A?

The CAS Registry Number of Nizatidine EP Impurity A is 54252-45-8. It is also known as N,N'-Dimethyl-2-nitro-1,1-ethenediamine, 1,1-Bis(methylamino)-2-nitroethene, N,N'-Dimethyl-2-nitroethene-1,1-diamine.

What is the molecular formula and molecular weight of Nizatidine EP Impurity A?

Nizatidine EP Impurity A has the molecular formula C4H9N3O2 and a molecular weight of 131.13 g/mol. Its IUPAC name is 1-N,1-N'-dimethyl-2-nitroethene-1,1-diamine.

What is Nizatidine EP Impurity A used for?

Nizatidine EP Impurity A is supplied as a characterised reference material related to Nizatidine. 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 Nizatidine EP Impurity A can I order?

We supply Nizatidine EP Impurity A in Reference Standard (99.46%) grade, in 10 mg, 25 mg, 50 mg, 100 mg, 250 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Nizatidine EP Impurity A?

Yes. Every lot of Nizatidine EP Impurity A 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 Nizatidine EP Impurity A be shipped internationally?

Yes. Nizatidine EP Impurity A 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.