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Pharmacopeial Impurities (EP / USP / BP)

Dienogest EP Impurity I

Reference StandardAvailable on request

Order Dienogest EP Impurity I (CAS 65928-65-6) online at Zemixal. Lab and bulk packs, batch COA, fast global delivery. Packs from 10 mg.

Pack sizes
Dienogest EP Impurity I chemical structure
CAS number65928-65-6
FormulaC20H27NO2
Molar mass313.4 g/mol
Physical formSolid
HS code38229090
InChIKeyWFQBBPSNJXAJGD-SWBPCFCJSA-N
IUPAC name2-[(8R,9S,13S,14S,17R)-17-hydroxy-13-methyl-3-oxo-1,2,4,6,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl]acetonitrile

About Dienogest EP Impurity I

Dienogest EP Impurity I belongs to the Dienogest reference-standard family in the Zemixal catalogue. Key data (Reference Standard): CAS 65928-65-6, formula C20H27NO2 and molar mass 313.4 g/mol. It is handled as a solid.

Typical applications

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

Storage and safety notes

It carries the GHS signal word Danger (H372, H400 and H410), so wear gloves and eye protection and work with good ventilation.

Available as 10 mg, 25 mg, 50 mg and 100 mg. Larger or split packs can be arranged. You receive a certificate of analysis with characterisation data with each order. Request pricing online and we confirm availability, documentation and freight to your country.

Reference standards for Dienogest

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

Dienogest 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 Dienogest EP Impurity I
Product nameDienogest EP Impurity I
Catalogue numberZX-024274
CAS number65928-65-6
IUPAC name2-[(8R,9S,13S,14S,17R)-17-hydroxy-13-methyl-3-oxo-1,2,4,6,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl]acetonitrile
Molecular formulaC20H27NO2
Molar mass313.4 g/mol
Exact mass313.2042
GradeReference Standard
Physical formSolid
XLogP32.3
H-bond donors / acceptors1 / 3
Topological polar surface area61.1 Ų
HS code38229090
InChIKeyWFQBBPSNJXAJGD-SWBPCFCJSA-N
SMILESC[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@]2(CC#N)O)CCC4=C3CCC(=O)C4
PubChem CID13175120
SynonymsDienogest - Impurity I, Dienogest Impurity I, (17alpha)-17-Hydroxy-3-oxo-19-norpregn-5(10)-ene-21-nitrile, STS-533, (17, A)-17-Hydroxy-3-oxo-19-norpregn-5(10)-ene-21-nitrile, 17-Hydroxy-3-oxo-19-norpregn-5(10)-ene-21-nitrile, (17alpha)-, 19-Norpregn-5(10)-ene-21-nitrile, 17-hydroxy-3-oxo-, (17alpha)-

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

Safety and GHS hazards

GHS08 Health hazard
Health hazard
GHS09 Hazardous to the environment
Hazardous to the environment

Signal word Danger

  • H372Causes damage to organs through prolonged or repeated exposure
  • H400Very toxic to aquatic life
  • H410Very toxic to aquatic life with long lasting effects

Precautionary statements P260, P264, P270, P273, P319, P391, 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 Dienogest EP Impurity I
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 Dienogest EP Impurity I

Which CAS number identifies Dienogest EP Impurity I?
Dienogest EP Impurity I is registered under CAS 65928-65-6. You may also see it listed as Dienogest - Impurity I, Dienogest Impurity I, (17alpha)-17-Hydroxy-3-oxo-19-norpregn-5(10)-ene-21-nitrile. Our catalogue number for this item is ZX-024274.
What are the formula and molar mass of Dienogest EP Impurity I?
For Dienogest EP Impurity I, its formula is C20H27NO2 and its molar mass is 313.4 g/mol. The systematic (IUPAC) name is 2-[(8R,9S,13S,14S,17R)-17-hydroxy-13-methyl-3-oxo-1,2,4,6,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl]acetonitrile. InChIKey WFQBBPSNJXAJGD-SWBPCFCJSA-N lets you match it in any structure database.
How is Dienogest EP Impurity I used in pharmaceutical QC?
Dienogest EP Impurity I is a characterised reference material linked to Dienogest. 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 Dienogest EP Impurity I?
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 Dienogest EP Impurity I?
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 Dienogest EP Impurity I to my country?
Yes. Because Dienogest EP Impurity I 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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