How to Source Dexrazoxane Hydrochloride for Pharmaceutical Formulation
Dexrazoxane Hydrochloride (Injection, 500 mg/50 mL, 250 mg/25 mL) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Zinecard (USA), Totect (USA), Cardioxane (EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Dexrazoxane Hydrochloride for formulation, R&D, or bulk manufacturing.
Product Overview:
Dexrazoxane hydrochloride is a cardioprotective agent used in oncology to minimize the risk of heart...
Dexrazoxane Hydrochloride API – ideal for compliant pharmaceutical formulation.
Quick Insight: Over 60% of formulation delays are linked to poor API sourcing. A well-planned sourcing strategy can reduce risk and accelerate market entry.
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
Dexrazoxane Hydrochloride 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 Dexrazoxane Hydrochloride is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Pro Tip: Engage supplier formulation experts early — it can improve bioavailability and cut development time.
Conclusion
Sourcing Dexrazoxane Hydrochloride is more than procurement—it’s a strategic partnership. With its injection form and 500 mg/50 mL, 250 mg/25 mL 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.
Next Step: Get expert assistance in sourcing Dexrazoxane Hydrochloride.
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Frequently Asked Questions For Sourcing of Dexrazoxane Hydrochloride
What is the typical lead time for Dexrazoxane Hydrochloride?
Lead times range from 4–6 weeks depending on supplier and region.
Is Dexrazoxane Hydrochloride available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Dexrazoxane Hydrochloride require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Dexrazoxane Hydrochloride?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Dexrazoxane Hydrochloride?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Dexrazoxane Hydrochloride?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Dexrazoxane Hydrochloride suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Dexrazoxane Hydrochloride be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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