Metformin Impurity 8

About Metformin Impurity 8

Metformin Impurity 8 is an impurity of Metformin carrying the CAS registry number 598-65-2. The compound has the formula C6H20N6O4S, corresponding to a molecular weight of 272.33 g/mol. It is also known as 1,1-Dimethylguanidine or N,N-Dimethylguanidine.

It is supplied as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. The GHS classification uses the signal word “Warning”, so appropriate gloves, eye protection and ventilation are recommended.

Pharmaceutical QC and development laboratories use this impurity standard of Metformin to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export worldwide.

Typical applications

Analytical method development
Method validation (AMV)
QC release testing
ANDA / DMF filings

Industries

Related to Metformin

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

Metformin impurities

Specifications & identifiers

Chemical identifiers
Product name	Metformin Impurity 8
Catalogue No.	VQ-049062
CAS Number	598-65-2
IUPAC name	bis(1,1-dimethylguanidine);sulfuric acid
Molecular formula	C₆H₂₀N₆O₄S
Molecular weight	272.33 g/mol
Exact mass	272.1267
Grade	Reference Standard
HSN code	38229090
InChIKey	QSCHFHVDZCPIKX-UHFFFAOYSA-N
SMILES	CN(C)C(=N)N.CN(C)C(=N)N.OS(=O)(=O)O
PubChem CID	69024

Physical properties
Physical form	Solid
H-bond donors / acceptors	6 / 6
TPSA	189 Å²
Synonyms	1,1-Dimethylguanidine, N,N-Dimethylguanidine, 1,1-dimethylguanidine sulfate(2:1), Guanidine, N,N-dimethyl-, sulfate (2:1), 1,1-Dimethylguanidine sulfate salt, Metformin Impurity 16, 1,1-Dimethyl guanidinium sulfate, 1,1-dimethylguanidine hemisulfate, 1,1-dimethylguanidine,sulfuric acid, 1,1-dimethylguanidinesulfate(2:1), 1,1-Dimethylguanidine sulfate (2:1), N,N-Dimethylguanidinium sulfate (2:1)

Safety & hazard information (GHS)

Harmful / irritant

Signal word: Warning

Hazard statements

H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation

Precautionary statements: P261, P264, P264 + P265, P271, P280, P302 + P352, P304 + P340, P305 + P351 + P338, P319, P321, P332 + P317, P337 + P317, P362 + P364, P403 + P233, 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 Metformin Impurity 8?

The CAS Registry Number of Metformin Impurity 8 is 598-65-2. It is also known as 1,1-Dimethylguanidine, N,N-Dimethylguanidine, 1,1-dimethylguanidine sulfate(2:1).

What is the molecular formula and molecular weight of Metformin Impurity 8?

Metformin Impurity 8 has the molecular formula C6H20N6O4S and a molecular weight of 272.33 g/mol.

What is Metformin Impurity 8 used for?

Metformin Impurity 8 is supplied as a characterised reference material related to Metformin. 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 Metformin Impurity 8 can I order?

We supply Metformin Impurity 8 in Reference Standard 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 Metformin Impurity 8?

Yes. Every lot of Metformin Impurity 8 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 Metformin Impurity 8 be shipped internationally?

Yes. Metformin Impurity 8 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.