Introduction
When sourcing Dapoxetine Hydrochloride (HCl) powder, price alone should never determine supplier choice. The global API market is flooded with suppliers, and while some provide GMP-certified, high-purity product, others ship adulterated, low-grade, or mislabeled powders.
To avoid costly mistakes, buyers must know how to verify quality before scaling orders. The three cornerstones of verification are:
- COA (Certificate of Analysis) – confirms batch specifications.
- HPLC (High Performance Liquid Chromatography) – verifies purity and identity.
- MSDS (Material Safety Data Sheet) – ensures safety, handling, and compliance.
This guide explains how to use these documents and tests to confirm the authenticity of Dapoxetine powder.
👉 For procurement strategy, see the Complete 2025 Buyer’s Guide to Dapoxetine HCl Powder.
Step 1: Reviewing the COA
A Certificate of Analysis (COA) is the first checkpoint in verifying a Dapoxetine shipment. Every supplier should provide a COA for the exact batch delivered.
Key COA Fields to Check
- Product Name & CAS No.: Dapoxetine HCl, CAS 129938-20-1
- Batch Number & Date: Ensures traceability
- Appearance: White to off-white crystalline powder
- Assay (Purity): ≥99% (HPLC method)
- Loss on Drying (LOD): ≤0.5%
- Heavy Metals: <10 ppm
- Residual Solvents: Within ICH Q3C limits
📌 Tip: COAs can be falsified. Always request third-party lab test results or run your own verification.
👉 Supplier comparisons available in Top Dapoxetine Powder Manufacturers & Suppliers 2025.
Step 2: Confirming with HPLC Testing
Even with a COA in hand, independent HPLC (High Performance Liquid Chromatography) analysis is critical.
Why HPLC Matters
- Confirms chemical identity (retention time compared to standard Dapoxetine).
- Detects impurities and degradation products.
- Quantifies purity percentage (≥99% expected).
Best Practices
- Send 100 g sample lot to an accredited third-party lab.
- Verify chromatogram peaks match Dapoxetine reference standard.
- Reject batches with unidentified peaks or purity <99%.
📊 Industry norm: Top GMP factories report Dapoxetine HCl purity between 99.0–99.5% HPLC.
👉 For long-term procurement, see Wholesale & Bulk Dapoxetine Powder Supply.
Step 3: Using the MSDS for Compliance
A Material Safety Data Sheet (MSDS) ensures safe handling, storage, and transport. Customs and regulatory agencies also require MSDS documentation for import/export.
Critical MSDS Sections
- Identification: Product name, CAS number, synonyms
- Hazard Classification: Irritant; toxic if misused
- First Aid Measures: Guidance for inhalation, ingestion, skin/eye exposure
- Handling & Storage: Store at 2–8°C, dry, sealed, away from light
- Transport Information: HS Code 29339990; shipping class not hazardous, but regulated as API
⚠️ Missing or incomplete MSDS is a red flag — shipments may be delayed or rejected at customs.
👉 For full template, see Dapoxetine Powder MSDS & Safety Guidelines.
Additional Verification Methods
- NMR (Nuclear Magnetic Resonance): Confirms molecular structure.
- IR Spectroscopy: Matches fingerprint region with Dapoxetine reference.
- Particle Size Distribution: Important for micronized batches.
- Stability Testing: Ensures 24–36 month shelf life under 2–8°C storage.
Buyer Red Flags
- Supplier refuses to provide COA or MSDS.
- COA reports exactly 100.0% purity (unrealistic, often fake).
- No batch number or manufacturing date on documents.
- Refusal to send samples for third-party testing.
- Quotes below $250/kg bulk (high probability of counterfeit).
Conclusion
Verifying Dapoxetine HCl powder quality is essential for avoiding financial loss, regulatory issues, and product failure.
Key steps:
- Start with COA review → look for ≥99% HPLC purity.
- Confirm via third-party HPLC test.
- Ensure a valid MSDS accompanies every batch.
- Use NMR, IR, and stability tests for advanced verification.
📌 Next Steps:
- Small-lot sourcing → Buy Dapoxetine Powder Online
- Scale with confidence
- Secure compliant vendors
By combining document review, analytical testing, and supplier audits, buyers can ensure every shipment of Dapoxetine powder meets pharma-grade standards.