Megestrol Acetate EP Impurity J

Megestrol Acetate EP Impurity J is a defined impurity of megestrol acetate, the synthetic progestin used in hormonal therapy and as an appetite stimulant in cachexia. Its formula C24H34O4 and molecular weight of 386.52 place it among the steroidal degradation and process-related impurities that require monitoring in the drug substance and its oral formulations. A characterised standard of this kind supports method development and validation, particularly for stability-indicating separations, as well as identification and confirmation of impurity peaks, system suitability assessment and the preparation of calibration standards for quantitative impurity determination. The material is a white to off-white solid, stored at -20 °C (±5 °C) and shipped with ice packs. Pack sizes offered are 10 mg, 20 mg, 25 mg, 50 mg, 55 mg, 60 mg, 100 mg and 200 mg. Requests for quotations or supporting documentation are welcome.
Also known as
Megestrol Acetate Impurity J. Further pharmacopoeial and trivial names are recorded on the certificate of analysis.
Pack sizes and lead time
| Pack size | Availability | Quote |
|---|---|---|
| 10 mg | In stock | |
| 20 mg | 14 days | |
| 25 mg | 14 days | |
| 50 mg | 14 days | |
| 55 mg | 14 days | |
| 60 mg | 14 days | |
| 100 mg | 14 days | |
| 200 mg | 14 days |
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: -20℃±5℃, Shipping with Ice Packs.
Frequently asked questions
Is a certificate of analysis (COA) available for Megestrol Acetate EP Impurity J?
Yes. A batch-specific COA and the MSDS are issued for every lot of Megestrol Acetate EP Impurity J (catalogue number C4X-141410). Use the COA link on this page, or email chao.lu@cato-chem.com 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 10 mg are held in stock and typically ship within 1–2 working days Other sizes (20 mg, 25 mg, 50 mg, 55 mg, 60 mg, 100 mg, 200 mg) are quoted with a lead time of approximately 14 days.
How is the purity of Megestrol Acetate EP Impurity J 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 chao.lu@cato-chem.com with the target quantity and required delivery date.
How is Megestrol Acetate EP Impurity J shipped?
Shipping conditions for this item: Shipping with Ice Packs. Shipments are packed to maintain the specified storage condition, and the SDS is provided for transport classification.