How to Source Metyrapone for Pharmaceutical Formulation

Metyrapone (Tablets, 250 mg) is classified under Women's Health. It is therapeutically aligned with reference brands such as Metopirone (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Metyrapone for formulation, R&D, or bulk manufacturing.

Product Overview: Metyrapone is a cortisol synthesis inhibitor used primarily in diagnostic testing of adrenal function (the metyrapone stimulation test). It works by blocking the enzyme 11‑beta‑hydroxylase in the adrenal gland, reducing cortisol production and allowing clinicians to assess pituitary ACTH reserve. In certain clinical situations, it may also be used to manage endogenous Cushing’s syndrome by lowering cortisol levels. Careful monitoring of hormone levels is required, and side effects can include nausea, dizziness, fatigue, and elevated ACTH.

1. Regulatory Compliance & Documentation

Ensure suppliers provide:

• ✔ Valid DMF (Drug Master File)
• ✔ COA (Certificate of Analysis) for each batch
• ✔ GMP, ISO, or ICH Q7 compliance certificates

2. Purity, Grade & Specification Matching

Metyrapone must meet exact grade and purity for your dosage form:

• ✔ USP / EP / JP grade verification
• ✔ Particle size distribution check
• ✔ Residual solvent and heavy metal limits

3. Supplier Reliability & Audit History

• ✔ Positive past audit reports
• ✔ Pharma client references
• ✔ Years of proven API manufacturing experience

4. Commercial Terms: Pricing, MOQ & Flexibility

• ✔ Transparent pricing
• ✔ Pilot batch MOQ flexibility
• ✔ Volume-based discounts

5. Lead Time, Inventory & Logistics

Typical lead time for Metyrapone is 4–6 weeks.

• ✔ Emergency dispatch options
• ✔ Regional warehousing
• ✔ Special storage if needed

6. Formulation Support

• ✔ Technical datasheets
• ✔ Sample availability
• ✔ Stability study support

Conclusion

Sourcing Metyrapone is more than procurement—it’s a strategic partnership. With its tablets form and 250 mg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.

Frequently Asked Questions For Sourcing of Metyrapone