Pirfenidone EP Impurity B

About Pirfenidone EP Impurity B

Pirfenidone EP Impurity B is a pharmacopeial impurity of Pirfenidone carrying the CAS registry number 1003-68-5. Formula C6H7NO, molecular weight 109.13 g/mol. Systematically, it is named 5-methyl-1H-pyridin-2-one. It is also known as 2-Hydroxy-5-Picoline or 2-Hydroxy-5-Picoline(Pirfenidone impurity).

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. Under GHS it is labelled “Danger”, so handle it with suitable PPE and consult the SDS.

This Pirfenidone impurity supports analytical method development and validation (AMV), batch release testing and the impurity sections of ANDA and DMF filings. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Pirfenidone EP Impurity B is dispatched with a Certificate of Analysis (COA) to destinations worldwide.

Typical applications

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

Industries

Related to Pirfenidone

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

Pirfenidone impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Pirfenidone EP Impurity B
Catalogue No.	VQ-023478
CAS Number	1003-68-5
IUPAC name	5-methyl-1H-pyridin-2-one
Molecular formula	C₆H₇NO
Molecular weight	109.13 g/mol
Exact mass	109.0528
Grade	Reference Standard
HSN code	38229090
InChIKey	SOHMZGMHXUQHGE-UHFFFAOYSA-N
SMILES	CC1=CNC(=O)C=C1
PubChem CID	70482

Physical properties
Physical form	Solid
LogP (XLogP3)	0.1
H-bond donors / acceptors	1 / 1
TPSA	29.1 Å²
Synonyms	2-Hydroxy-5-Picoline, 2-Hydroxy-5-Picoline(Pirfenidone impurity), Pirfenidone - Impurity B, Pirfenidone Related Compound B, 2-Hydroxy-5-methylpyridine, 5-Methyl-2-pyridone, 5-Methyl-2(1H)-pyridinone, 5-methylpyridin-2-ol, 5-Methylpyridin-2(1H)-one, 5-Methyl-2-pyridinol, 2-Pyridinol, 5-methyl-, 2(1H)-Pyridinone, 5-methyl-

Safety & hazard information (GHS)

Corrosive

Harmful / irritant

Signal word: Danger

Hazard statements

H302Harmful if swallowed
H315Causes skin irritation
H318Causes serious eye damage
H319Causes serious eye irritation
H335May cause respiratory irritation

Precautionary statements: P261, P264, P264 + P265, P270, P271, P280, P301 + P317, P302 + P352, P304 + P340, P305 + P351 + P338, P305 + P354 + P338, P317, P319, P321, P330, 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 Pirfenidone EP Impurity B?

The CAS Registry Number of Pirfenidone EP Impurity B is 1003-68-5. It is also known as 2-Hydroxy-5-Picoline, 2-Hydroxy-5-Picoline(Pirfenidone impurity), Pirfenidone - Impurity B.

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

Pirfenidone EP Impurity B has the molecular formula C6H7NO and a molecular weight of 109.13 g/mol. Its IUPAC name is 5-methyl-1H-pyridin-2-one.

What is Pirfenidone EP Impurity B used for?

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

We supply Pirfenidone 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 Pirfenidone EP Impurity B?

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

Yes. Pirfenidone 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.