Introduction
With the rise of generic Cialis® production and widespread API exports from China and India, the market for Tadalafil raw powder has grown significantly. Unfortunately, this expansion also increases the risk of counterfeit or substandard material entering supply chains.
To ensure safety, compliance, and efficacy, buyers must know how to check the quality of Tadalafil powder before scaling contracts. This article covers USP/EP standards, Certificate of Analysis (COA), and lab testing methods like HPLC.
👉 For an overview of procurement, see the Complete 2025 Buyer’s Guide to Tadalafil Raw Powder.
USP/EP Standards for Tadalafil Powder
Pharmaceutical-grade Tadalafil must meet strict pharmacopeial requirements (USP, EP, ICH).
Key Specifications:
- Appearance: White to off-white crystalline powder.
- Purity (Assay): ≥99% by HPLC.
- Related Substances: ≤0.5% total impurities.
- Loss on Drying: ≤0.5%.
- Residual Solvents: Within ICH Q3C limits.
- Heavy Metals: ≤10 ppm.
- Shelf Life: 24–36 months under 2–8°C storage.
⚠️ Red Flag: Yellow or brown discoloration, clumping, or unusual odor may indicate degradation or contamination.
👉 For safe handling details, see Tadalafil MSDS & Safety Guidelines.
Reviewing the Certificate of Analysis (COA)
A COA is the first document buyers must request.
Checklist for COA Verification:
- Product name: Tadalafil / Tadalafil Citrate
- CAS Number: 171596-29-5
- Batch/Lot Number (traceability)
- Assay result (≥99% HPLC)
- Appearance: white/off-white crystalline
- Residual solvents + heavy metals data
- Date of testing + signature/stamp of lab QA
📌 Red Flag: A generic template COA without batch-specific data is unreliable.
👉 For supplier vetting, see Top Tadalafil Powder Manufacturers & Suppliers 2025.
Independent Analytical Testing
Even with COA, third-party testing is critical for confirmation.
HPLC (High-Performance Liquid Chromatography)
- Confirms chemical identity (retention time match).
- Measures purity vs impurities.
- Industry standard: ≥99.0% purity.
NMR (Nuclear Magnetic Resonance)
- Confirms molecular structure matches reference compound.
IR (Infrared Spectroscopy)
- Verifies molecular fingerprint.
Residual Solvent & Heavy Metals Testing
- Must comply with ICH Q3C and USP <232>.
- Ensures safe limits for solvents and trace metals.
📊 Industry Benchmark: Top Indian and Chinese GMP plants report 99.0–99.5% purity (HPLC).
Packaging & Physical Checks
High-quality Tadalafil powder should arrive in:
- 1–5 kg vacuum-sealed foil bags (inner packaging).
- 25 kg fiber drums (outer packaging).
- Labels with CAS number, batch ID, storage instructions, expiry date.
- Consistent white/off-white crystalline appearance.
⚠️ If the powder has grainy texture, unusual taste, or off-color, it may be adulterated.
👉 For packaging details, see Wholesale & Bulk Tadalafil Powder Supply Guide.
Common Buyer Mistakes
- Accepting “100% purity” claims (no real API ever tests at exactly 100%).
- Skipping third-party HPLC testing for pilot lots.
- Ignoring batch-specific COA.
- Buying from unverified middlemen without export history.
- Accepting plastic bag packaging instead of double-sealed foil + drum.
Buyer’s Mini-Checklist for Quality
- Request batch-specific COA + GMP + MSDS.
- Confirm HPLC purity ≥99%.
- Inspect appearance: white/off-white crystalline.
- Run independent HPLC/NMR tests on pilot lots.
- Verify packaging: vacuum-sealed foil inside fiber drum.
👉 For small-lot verification, see Buy Tadalafil Powder Online: Verified Sources & Compliance.
Conclusion
Ensuring Tadalafil powder quality is non-negotiable for manufacturers, distributors, and research labs.
Key Takeaways:
- Meet USP/EP standards (purity ≥99%).
- Validate batch with COA + independent HPLC/NMR testing.
- Reject suppliers who lack GMP/MSDS or proper packaging.
- Use pilot orders before scaling to wholesale contracts.
📌 Next Steps:
- Direct sourcing
- Scale with confidence
- Vet factories
By combining document review, lab testing, and packaging checks, buyers can avoid counterfeit risk and build a compliant Tadalafil supply chain.