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Pharmacopeial Impurities (EP / USP / BP)

Tadalafil EP Impurity I

Reference StandardAvailable on request

Order Tadalafil EP Impurity I (CAS 2378614-29-8) online at Zemixal. Request a quote with price, lead time and documents.

Pack sizes
Tadalafil EP Impurity I chemical structure
CAS number2378614-29-8
FormulaC22H19N3O5
Molar mass405.4 g/mol
Physical formSolid
HS code38229090
InChIKeyJLEQLXGZAIAEFX-DMXYAQSFSA-N
IUPAC name(8'aR)-6'-(1,3-benzodioxol-5-yl)-2'-methylspiro[1H-indole-3,7'-3,6,8,8a-tetrahydropyrrolo[1,2-a]pyrazine]-1',2,4'-trione

About Tadalafil EP Impurity I

Zemixal lists Tadalafil EP Impurity I for laboratories that identify, quantify or control Tadalafil and its related substances. For your records (Reference Standard), the material is defined by CAS 2378614-29-8, formula C22H19N3O5 and molar mass 405.4 g/mol. It is handled as a solid.

Use cases we see most often

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

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and custom quantities are quoted on request. Each lot travels with a certificate of analysis with characterisation data. Request pricing online and we confirm availability, documentation and freight to your country.

Reference standards for Tadalafil

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

Tadalafil 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 Tadalafil EP Impurity I
Product nameTadalafil EP Impurity I
Catalogue numberZX-027080
CAS number2378614-29-8
IUPAC name(8'aR)-6'-(1,3-benzodioxol-5-yl)-2'-methylspiro[1H-indole-3,7'-3,6,8,8a-tetrahydropyrrolo[1,2-a]pyrazine]-1',2,4'-trione
Molecular formulaC22H19N3O5
Molar mass405.4 g/mol
Exact mass405.1325
GradeReference Standard
Physical formSolid
XLogP31
H-bond donors / acceptors1 / 5
Topological polar surface area88.2 Ų
HS code38229090
InChIKeyJLEQLXGZAIAEFX-DMXYAQSFSA-N
SMILESCN1CC(=O)N2[C@@H](C1=O)CC3(C2C4=CC5=C(C=C4)OCO5)C6=CC=CC=C6NC3=O
PubChem CID135390716
SynonymsTadalafil - Impurity I

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

Safety and GHS hazards

No GHS classification is on file for this item. Handle it as an unknown laboratory chemical and request the SDS with your quotation.

Pack sizes

Pack sizes of Tadalafil 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 Tadalafil EP Impurity I

Which CAS number identifies Tadalafil EP Impurity I?
Tadalafil EP Impurity I is registered under CAS 2378614-29-8. You may also see it listed as Tadalafil - Impurity I. Our catalogue number for this item is ZX-027080.
What are the formula and molar mass of Tadalafil EP Impurity I?
For Tadalafil EP Impurity I, its formula is C22H19N3O5 and its molar mass is 405.4 g/mol. The systematic (IUPAC) name is (8'aR)-6'-(1,3-benzodioxol-5-yl)-2'-methylspiro[1H-indole-3,7'-3,6,8,8a-tetrahydropyrrolo[1,2-a]pyrazine]-1',2,4'-trione. InChIKey JLEQLXGZAIAEFX-DMXYAQSFSA-N lets you match it in any structure database.
How is Tadalafil EP Impurity I used in pharmaceutical QC?
Tadalafil EP Impurity I is a characterised reference material linked to Tadalafil. 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 Tadalafil 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 Tadalafil 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 Tadalafil EP Impurity I to my country?
Yes. Tadalafil EP Impurity I ships worldwide by express courier, air cargo or sea freight, quoted on the Incoterm you prefer, with full export documents.

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