Clavulanate Potassium EP Impurity K

About Clavulanate Potassium EP Impurity K

Clavulanate Potassium EP Impurity K is a pharmacopeial impurity of Clavulanate carrying the CAS registry number 107-45-9. Formula C8H19N, molecular weight 129.24 g/mol. Its systematic (IUPAC) name is 2,4,4-trimethylpentan-2-amine. It is also known as Potassium Clavulanate EP Impurity K or 1,1,3,3-Tetramethylbutylamine.

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. It carries the GHS signal word “Danger” with 7 hazard statements. Review the Safety Data Sheet before use.

Pharmaceutical QC and development laboratories use this impurity standard of Clavulanate to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Our customers for this product work in pharmaceutical manufacturing and academic and industrial research.

We offer Clavulanate Potassium EP Impurity K in 10 mg, 25 mg, 50 mg and 100 mg packs with a batch-specific COA, and ship to customers worldwide.

Typical applications

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

Industries

Related to Clavulanate

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

Clavulanate impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Clavulanate Potassium EP Impurity K
Catalogue No.	VQ-021292
CAS Number	107-45-9
IUPAC name	2,4,4-trimethylpentan-2-amine
Molecular formula	C₈H₁₉N
Molecular weight	129.24 g/mol
Exact mass	129.1517
Grade	Reference Standard
HSN code	38229090
InChIKey	QIJIUJYANDSEKG-UHFFFAOYSA-N
SMILES	CC(C)(C)CC(C)(C)N
PubChem CID	61017

Physical properties
Physical form	Solid
LogP (XLogP3)	2
H-bond donors / acceptors	1 / 1
TPSA	26 Å²
Synonyms	Potassium Clavulanate EP Impurity K, 1,1,3,3-Tetramethylbutylamine, Clavulanic Acid EP Impurity K, Clavulanate EP Impurity K, Clavulanate Potassium - Impurity K, tert-Octylamine, 2,4,4-Trimethyl-2-pentylamine, 1,1,3,3-Tetramethylbutanamine, Butylamine, 1,1,3,3-tetramethyl-, 2,4,4-Trimethyl-2-pentanamine, 2-Amino-2,4,4-trimethylpentane, Butylamine, bis(1,3-dimethyl)-

Safety & hazard information (GHS)

Flammable

Corrosive

Toxic

Harmful / irritant

Environmental hazard

Signal word: Danger

Hazard statements

H226Flammable liquid and vapor
H290May be corrosive to metals
H301Toxic if swallowed
H302Harmful if swallowed
H314Causes severe skin burns and eye damage
H318Causes serious eye damage
H411Toxic to aquatic life with long lasting effects

Precautionary statements: P210, P233, P234, P240, P241, P242, P243, P260, P264, P264 + P265, P270, P273, P280, P301 + P316, P301 + P317, P301 + P330 + P331, P302 + P361 + P354, P303 + P361 + P353, P304 + P340, P305 + P354 + P338, P316, P317, P321, P330

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 Clavulanate Potassium EP Impurity K?

The CAS Registry Number of Clavulanate Potassium EP Impurity K is 107-45-9. It is also known as Potassium Clavulanate EP Impurity K, 1,1,3,3-Tetramethylbutylamine, Clavulanic Acid EP Impurity K.

What is the molecular formula and molecular weight of Clavulanate Potassium EP Impurity K?

Clavulanate Potassium EP Impurity K has the molecular formula C8H19N and a molecular weight of 129.24 g/mol. Its IUPAC name is 2,4,4-trimethylpentan-2-amine.

What is Clavulanate Potassium EP Impurity K used for?

Clavulanate Potassium EP Impurity K is supplied as a characterised reference material related to Clavulanate. 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 Clavulanate Potassium EP Impurity K can I order?

We supply Clavulanate Potassium EP Impurity K 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 Clavulanate Potassium EP Impurity K?

Yes. Every lot of Clavulanate Potassium EP Impurity K 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 Clavulanate Potassium EP Impurity K be shipped internationally?

Yes. Clavulanate Potassium EP Impurity K 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.