Pregabalin EP Impurity A

Name: Pregabalin EP Impurity A
Brand: Vaqora Chemicals
SKU: VQ-027611

About Pregabalin EP Impurity A

Vaqora Chemicals supplies Pregabalin EP Impurity A, a pharmacopeial impurity of Pregabalin registered under CAS number 181289-23-6. With the molecular formula C8H15NO, it has a molar mass of 141.21 g/mol. The IUPAC name is (4S)-4-(2-methylpropyl)pyrrolidin-2-one. Common synonyms include Pregabalin Impurity A and Pregabalin - Impurity A.

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 “Danger”, so appropriate gloves, eye protection and ventilation are recommended.

Pharmaceutical QC and development laboratories use this impurity standard of Pregabalin 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 Pregabalin EP Impurity A 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 Pregabalin

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

Pregabalin impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Pregabalin EP Impurity A
Catalogue No.	VQ-027611
CAS Number	181289-23-6
IUPAC name	(4S)-4-(2-methylpropyl)pyrrolidin-2-one
Molecular formula	C₈H₁₅NO
Molecular weight	141.21 g/mol
Exact mass	141.1154
Grade	Reference Standard
HSN code	38229090
InChIKey	GUGXRXLTTHFKHC-ZETCQYMHSA-N
SMILES	CC(C)C[C@H]1CC(=O)NC1
PubChem CID	16101324

Physical properties
Physical form	Solid
LogP (XLogP3)	1.2
H-bond donors / acceptors	1 / 1
TPSA	29.1 Å²
Synonyms	Pregabalin Impurity A, Pregabalin - Impurity A, Pregabalin EP Impurity A, (S)-Pregabalin Lactam, (S)-4-Isobutylpyrrolidin-2-one, Pregabalin Lactam, 2-Pyrrolidinone, 4-(2-methylpropyl)-, (4S)-, (S)-Pregabalin Lactam, (S)-4-(Isobutyl)pyrrolidin-2-one, (s)-4-isobutyl-2-pyrrolidinone, (4S)-4-(2-Methylpropyl)pyrrolidin-2-one ((S)-Pregabalin Lactam), (S)-4-isobutyl-pyrrolidin-2-one, (S)-4-(2-Methylpropyl)-2-pyrrolidinone

Safety & hazard information (GHS)

Corrosive

Health hazard

Signal word: Danger

Hazard statements

H318Causes serious eye damage
H361Suspected of damaging fertility or the unborn child

Precautionary statements: P203, P264 + P265, P280, P305 + P354 + P338, P317, 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 Pregabalin EP Impurity A?

The CAS Registry Number of Pregabalin EP Impurity A is 181289-23-6. It is also known as Pregabalin Impurity A, Pregabalin - Impurity A, Pregabalin EP Impurity A, (S)-Pregabalin Lactam.

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

Pregabalin EP Impurity A has the molecular formula C8H15NO and a molecular weight of 141.21 g/mol. Its IUPAC name is (4S)-4-(2-methylpropyl)pyrrolidin-2-one.

What is Pregabalin EP Impurity A used for?

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

We supply Pregabalin EP Impurity A 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 Pregabalin EP Impurity A?

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

Yes. Pregabalin 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.