Pregabalin EP Impurity B

Name: Pregabalin EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-006605

About Pregabalin EP Impurity B

Pregabalin EP Impurity B is a pharmacopeial impurity of Pregabalin carrying the CAS registry number 148553-51-9. Formula C8H17NO2, molecular weight 159.23 g/mol. The IUPAC name is (3R)-3-(aminomethyl)-5-methylhexanoic acid. Alternative names: (R)-3-(Aminomethyl)-5-methylhexanoic acid and (R)-Pregabalin.

The product is provided 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. It is used across pharmaceutical manufacturing and academic and industrial research.

We offer Pregabalin EP Impurity B 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 Pregabalin

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

Pregabalin impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Pregabalin EP Impurity B
Catalogue No.	VQ-006605
CAS Number	148553-51-9
IUPAC name	(3R)-3-(aminomethyl)-5-methylhexanoic acid
Molecular formula	C₈H₁₇NO₂
Molecular weight	159.23 g/mol
Exact mass	159.1259
Grade	Reference Standard
HSN code	38229090
InChIKey	AYXYPKUFHZROOJ-SSDOTTSWSA-N
SMILES	CC(C)C[C@H](CC(=O)O)CN
PubChem CID	125889

Physical properties
Physical form	Solid
LogP (XLogP3)	-1.6
H-bond donors / acceptors	2 / 3
TPSA	63.3 Å²
Synonyms	(R)-3-(Aminomethyl)-5-methylhexanoic acid, (R)-Pregabalin, ent-Pregabalin, Pregabalin, (R)-, Hexanoic acid, 3-(aminomethyl)-5-methyl-, (3R)-, Pregabalin(Renantiomer), Pregabalin (R enantiomer), Pregabalin impurity B CRS, EX-A4191, Pregabalin EP Impurity B/(R)-Pregabalin

Safety & hazard information (GHS)

Corrosive

Harmful / irritant

Health hazard

Signal word: Danger

Hazard statements

H318Causes serious eye damage
H336May cause drowsiness or dizziness
H361Suspected of damaging fertility or the unborn child

Precautionary statements: P203, P261, P264 + P265, P271, P280, P304 + P340, P305 + P354 + P338, P317, P318, P319, 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 Pregabalin EP Impurity B?

The CAS Registry Number of Pregabalin EP Impurity B is 148553-51-9. It is also known as (R)-3-(Aminomethyl)-5-methylhexanoic acid, (R)-Pregabalin, ent-Pregabalin.

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

Pregabalin EP Impurity B has the molecular formula C8H17NO2 and a molecular weight of 159.23 g/mol. Its IUPAC name is (3R)-3-(aminomethyl)-5-methylhexanoic acid.

What is Pregabalin EP Impurity B used for?

Pregabalin EP Impurity B 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 B can I order?

We supply Pregabalin EP Impurity B 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 B?

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

Yes. Pregabalin EP Impurity B 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.