Tadalafil EP Impurity F

Tadalafil EP Impurity F is a defined impurity of tadalafil, a phosphodiesterase type 5 inhibitor used in the treatment of erectile dysfunction and pulmonary arterial hypertension. With a formula of C22H19N3O6 and a molecular weight of 421.40, it represents one of the process-related or degradation species that must be accounted for when the drug substance and its finished products are controlled. Analytical laboratories therefore use it to develop and validate stability-indicating methods, to identify and confirm impurity peaks by retention time and mass spectrometric response, to assess system suitability and resolution, and to prepare calibration solutions for quantitative determination. The material is a white to off-white solid, kept at 2 to 8 °C and shipped at room temperature. Pack sizes offered include 5 mg, 10 mg, 20 mg, 25 mg, 30 mg, 50 mg, 60 mg, 100 mg, 110 mg and 500 mg. Quotations and documentation are available on request.
Also known as
Tadalafil EP Impurity F; Tadalafil Spiro-urethane Impurity (EP Impurity F); TADALAFIL IMPURITY F [EP IMPURITY]. Further pharmacopoeial and trivial names are recorded on the certificate of analysis.
Chemical identifiers
- InChIKey
- ZUCOJEUKLPYQMG-DMXYAQSFSA-N
- SMILES
- CN1CC(=O)N2[C@@H](C1=O)CC3(C2C4=CC5=C(C=C4)OCO5)C6=CC=CC=C6NC(=O)O3
- PubChem CID
- 135390931
- IUPAC name
- (8'aR)-6'-(1,3-benzodioxol-5-yl)-2'-methylspiro[1H-3,1-benzoxazine-4,7'-3,6,8,8a-tetrahydropyrrolo[1,2-a]pyrazine]-1',2,4'-trione
Identifiers are provided so that this standard can be matched unambiguously against a structure, a database entry or an in-house method file.
Pack sizes and lead time
| Pack size | Availability | Quote |
|---|---|---|
| 5 mg | In stock | |
| 10 mg | In stock | |
| 20 mg | In stock | |
| 25 mg | In stock | |
| 30 mg | In stock | |
| 50 mg | In stock | |
| 60 mg | In stock | |
| 100 mg | On request | |
| 110 mg | 10 days | |
| 500 mg | On request |
What the documents contain
- Certificate of analysis — issued per lot: catalogue and lot number, the value assigned to the material and the analytical basis for it.
- Safety data sheet — supplied for the catalogue item, and the basis for the transport classification used on the shipment.
- Storage and shipping conditions for this item: 2℃ ~ 8℃, Shipping at Room Temperature.
Frequently asked questions
Is a certificate of analysis (COA) available for Tadalafil EP Impurity F?
Yes. A batch-specific COA and the MSDS are issued for every lot of Tadalafil EP Impurity F (catalogue number C4X-10876). Use the COA link on this page, or email [email protected] with the lot number printed on your label and we will send the matching document.
What pack sizes and lead times are offered?
Pack sizes 5 mg, 10 mg, 20 mg, 25 mg, 30 mg, 50 mg, 60 mg are held in stock and typically ship within 1–2 working days Other sizes (110 mg) are quoted with a lead time of approximately 10 days.
How is the purity of Tadalafil EP Impurity F documented?
Purity is determined per batch and stated on the COA together with the analytical data used for its assignment. If your method requires a specific grade or a particular pharmacopoeial naming, tell us the requirement when you enquire and we will confirm suitability.
Can you supply a larger quantity or a custom synthesis?
Yes. Quantities above the listed pack sizes are quoted on request, and custom synthesis or isolation from related starting materials can be discussed for compounds not held in stock. Contact [email protected] with the target quantity and required delivery date.
How is Tadalafil EP Impurity F shipped?
Shipping conditions for this item: Shipping at Room Temperature. Shipments are packed to maintain the specified storage condition, and the SDS is provided for transport classification.
