Buprenorphine EP Impurity C

About Buprenorphine EP Impurity C

Buprenorphine EP Impurity C is a pharmacopeial impurity of Buprenorphine carrying the CAS registry number 16614-60-1. Its molecular formula is C27H36N2O4 and its molecular weight is 452.6 g/mol. Alternative names: Buprenorphine - Impurity C (PSY) and N-Cyano-3-O-methyl Norbuprenorphine.

It is supplied as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. It carries the GHS signal word “Danger” with 4 hazard statements. Review the Safety Data Sheet before use.

This Buprenorphine impurity supports analytical method development and validation (AMV), batch release testing and the impurity sections of ANDA and DMF filings. Buyers come mainly from 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

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

Industries

Related to Buprenorphine

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

Buprenorphine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Buprenorphine EP Impurity C
Catalogue No.	VQ-045160
CAS Number	16614-60-1
IUPAC name	(1S,2S,6R,14R,15R,16R)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-11,15-dimethoxy-13-oxa-5-azahexacyclo[13.2.2.12,8.01,6.02,14.012,20]icosa-8(20),9,11-triene-5-carbonitrile
Molecular formula	C₂₇H₃₆N₂O₄
Molecular weight	452.6 g/mol
Exact mass	452.2675
Grade	Reference Standard
HSN code	38229090
InChIKey	BNIUSDKOHBJDSD-VFERFCJDSA-N
SMILES	C[C@]([C@H]1C[C@@]23CC[C@@]1([C@H]4[C@@]25CCN([C@@H]3CC6=C5C(=C(C=C6)OC)O4)C#N)OC)(C(C)(C)C)O
PubChem CID	13324144

Physical properties
Physical form	Solid
LogP (XLogP3)	4.8
H-bond donors / acceptors	1 / 6
TPSA	75 Å²

Safety & hazard information (GHS)

Harmful / irritant

Health hazard

Signal word: Danger

Hazard statements

H302Harmful if swallowed
H317May cause an allergic skin reaction
H332Harmful if inhaled
H334May cause allergy or asthma symptoms or breathing difficulties if inhaled

Precautionary statements: P233, P260, P261, P264, P270, P271, P272, P280, P284, P301 + P317, P302 + P352, P304 + P340, P317, P321, P330, P333 + P317, P342 + P316, P362 + P364, P403, 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 Buprenorphine EP Impurity C?

The CAS Registry Number of Buprenorphine EP Impurity C is 16614-60-1. It is also known as Buprenorphine - Impurity C (PSY), N-Cyano-3-O-methyl Norbuprenorphine, 3-O-Methyl-N-cyanonorbuprenorphine.

What is the molecular formula and molecular weight of Buprenorphine EP Impurity C?

Buprenorphine EP Impurity C has the molecular formula C27H36N2O4 and a molecular weight of 452.6 g/mol.

What is Buprenorphine EP Impurity C used for?

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

We supply Buprenorphine EP Impurity C 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 Buprenorphine EP Impurity C?

Yes. Every lot of Buprenorphine EP Impurity C 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 Buprenorphine EP Impurity C be shipped internationally?

Yes. Buprenorphine EP Impurity C 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.