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Pharmacopeial Impurities (EP / USP / BP)

Buprenorphine EP Impurity B

Reference StandardAvailable on request

Order Buprenorphine EP Impurity B (CAS 78715-23-8) online at Zemixal. Request a quote with price, lead time and documents.

Pack sizes
Buprenorphine EP Impurity B chemical structure
CAS number78715-23-8
FormulaC25H35NO4
Molar mass413.5 g/mol
Physical formSolid
HS code38229090
InChIKeyYOYLLRBMGQRFTN-IOMBULRVSA-N
IUPAC name(1S,2S,6R,14R,15R,16R)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-5-azahexacyclo[13.2.2.12,8.01,6.02,14.012,20]icosa-8(20),9,11-trien-11-ol

About Buprenorphine EP Impurity B

Buprenorphine EP Impurity B belongs to the Buprenorphine reference-standard family in the Zemixal catalogue. For your records (Reference Standard), the material is defined by CAS 78715-23-8, formula C25H35NO4 and molar mass 413.5 g/mol. It is handled as a solid.

Where it is used

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

Handling and storage

Classified under GHS with signal word Danger and hazard statements H302+H332, H302, H317 and H332. Read the SDS before first use.

Order it in 10 mg, 25 mg, 50 mg and 100 mg packs or ask for a bulk quotation. Every shipment includes a certificate of analysis with characterisation data. Send an enquiry through the quote panel and you get a formal offer with Incoterms and delivery time.

Reference standards for Buprenorphine

See every impurity, metabolite and related compound we list for this API.

Buprenorphine standards

Typical uses

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

Applications

Pharmaceutical Manufacturing and QCResearch Labs and Universities

Grade guides

Ph. Eur. Grade (European Pharmacopoeia)

Specifications and identifiers

Specifications of Buprenorphine EP Impurity B
Product nameBuprenorphine EP Impurity B
Catalogue numberZX-036889
CAS number78715-23-8
IUPAC name(1S,2S,6R,14R,15R,16R)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-5-azahexacyclo[13.2.2.12,8.01,6.02,14.012,20]icosa-8(20),9,11-trien-11-ol
Molecular formulaC25H35NO4
Molar mass413.5 g/mol
Exact mass413.2566
GradeReference Standard
Physical formSolid
XLogP33.8
H-bond donors / acceptors3 / 5
Topological polar surface area71 Ų
HS code38229090
InChIKeyYOYLLRBMGQRFTN-IOMBULRVSA-N
SMILESC[C@]([C@H]1C[C@@]23CC[C@@]1([C@H]4[C@@]25CCN[C@@H]3CC6=C5C(=C(C=C6)O)O4)OC)(C(C)(C)C)O
PubChem CID114976
SynonymsBuprenorphine - Impurity B (PSY), Norbuprenorphine, Des(cyclopropylmethyl)buprenorphine

Lot values are stated on the batch certificate of analysis. Ask for a typical COA with your quotation.

Safety and GHS hazards

GHS07 Irritant or harmful
Irritant or harmful
GHS08 Health hazard
Health hazard

Signal word Danger

  • H302+H332Harmful if swallowed or if inhaled
  • 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 summarised from public GHS notifications. It can vary with grade and concentration, so always follow the SDS supplied with your lot.

Pack sizes

Pack sizes of Buprenorphine EP Impurity B
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request

Need a different size? Bulk drums and custom packing are quoted on request through the quote form on this page.

Questions about Buprenorphine EP Impurity B

Which CAS number identifies Buprenorphine EP Impurity B?
Buprenorphine EP Impurity B is registered under CAS 78715-23-8. You may also see it listed as Buprenorphine - Impurity B (PSY), Norbuprenorphine, Des(cyclopropylmethyl)buprenorphine. Our catalogue number for this item is ZX-036889.
What are the formula and molar mass of Buprenorphine EP Impurity B?
For Buprenorphine EP Impurity B, its formula is C25H35NO4 and its molar mass is 413.5 g/mol. The systematic (IUPAC) name is (1S,2S,6R,14R,15R,16R)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-5-azahexacyclo[13.2.2.12,8.01,6.02,14.012,20]icosa-8(20),9,11-trien-11-ol. InChIKey YOYLLRBMGQRFTN-IOMBULRVSA-N lets you match it in any structure database.
How is Buprenorphine EP Impurity B used in pharmaceutical QC?
Buprenorphine EP Impurity B is a characterised reference material linked to Buprenorphine. Laboratories use it to identify and quantify this impurity during method development and validation, stability work, batch release testing and regulatory submissions.
What grade and pack sizes are available for Buprenorphine EP Impurity B?
This listing is Reference Standard grade. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Buprenorphine EP Impurity B?
Each lot ships with a batch certificate of analysis and a 16-section GHS safety data sheet. A typical COA or specification sheet can be shared with the quotation before you order.
Can Zemixal ship Buprenorphine EP Impurity B to my country?
Yes. Because Buprenorphine EP Impurity B is classed as hazardous, it travels in UN-approved packaging as dangerous goods under IATA or IMDG rules, with the export paperwork your broker needs.

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