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Tadalafil Raw Powder
2. Appearance: White powder
3. Specification: 98%
4. Chemical Abstracts Service ID: 171596-29-5
5. Molecular formula: C22H19N3O4
6. Molecular weight: 389.4
7. Payment method: telegraphic transfer to Alipay
8. Certificates: US Food and Drug Administration, Organic Food, kosher ISO、HALAL、HACCP、GMP
9. Transport packaging: 1kg aluminum foil bag/25kg drum
10. Factory situation: Factory and three production lines. GMP standard workshop and two independent laboratories.
11. Storage method: Keep in a dry and cool place
12.Export only
- Product Description
Pharmaceutical-Grade Tadalafil Raw Powder | cGMP/ISO/FDA-Certified Supplier for Bulk API
When you need reliable, high-quality tadalafil raw powder for making drugs, it's very important to get the proper provider. We analyze the purity of our pharmaceutical-grade raw materials with advanced high-performance liquid chromatography (HPLC) technology to make sure they meet high international standards. Our main technology is "multi-stage solvent recrystallization + aerodynamic micronization." This makes sure that tadalafil is always more than 99.5% pure, and by changing its shape, the particle size is kept to D90 < 10μm, which means that the dissolving rate in the human body is 40% faster, giving your formulation's bioequivalence (BE) studies the best possible base.
Tadalafil bulk powder is a high-quality active pharmaceutical ingredient (API) that is used to make medications that treat erectile dysfunction (ED) and pulmonary arterial hypertension. Our medication meets the strict standards set by the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). This means that it has a high bioavailability and strong therapeutic effects. This tadalafil powder for sale is at least 98% pure (HPLC certified) and stable from batch to batch, therefore it is perfect for producing many different kinds of medications.
Tadalafil Advantages
1. Extreme Impurity Profile Control: We adhere to the latest USP/EP standards, utilizing LC-MS/MS to eliminate single impurities, ensuring any single impurity is less than 0.1%.
2. Exclusive Customized "Ultra-fine Powder" Processing: We possess an independent multi-stage micronization workshop. Whether your process involves direct compression flake formation or wet granulation, we can provide matching particle size specifications (such as specific ranges like D50 and D90).
3. 100% Transparent Origin and Audit Support: As a physical factory with over 20 years of production experience, Shaanxi Hongda provides complete DMF documents, stability test data, and batch records. We welcome clients to conduct online factory video audits or third-party on-site inspections to ensure your supply chain complies with GxP specifications.
4. Global "Green Channel" Compliant Delivery: We employ light-proof, anti-static, multi-layer composite anti-counterfeiting packaging. We have established customs clearance partners in the US, Europe, and Southeast Asia, ensuring that goods not only arrive but also legally, safely, and quickly enter your laboratory.
Product Specification
Product name | Tadalafil Powder | ||||||||
Appearance | white or almost white powder. | Almost white powder | Complies | ||||||
Appearance | Solubility | Freely soluble in dimethyl sulfoxide, slightly soluble in dichloromethane, practically insoluble in water. | Freely soluble in dimethyl sulfoxide, slightly soluble in dichloromethane, practically insoluble in water. | Complies | |||||
Identification | Infrared Absorption | The infrared absorption spectrum of the sample shall be consistent with that of the reference substance. | Complies | Complies | |||||
HPLC | The retention time of the major peak of the Sample solution corresponds to that of the Identification solution, as obtained in the test for Enantiomeric and Diastere- omeric Purity. | Complies | Complies | ||||||
Analysis | Organic impurities | Individual impurities not more than 0.1% | 0.012% | Complies | |||||
Total impurities not more than 0 . 3 % | 0.020% | ||||||||
Analysis | Enantiomeric | 6R,12aS diastereomer not more than 0.1% | Not detected | Complies | |||||
6 S,12 aS enantiomer not more than 0. 1% | Not detected | ||||||||
6S,12aR diastereomer not more than 0.1% | Not detected | ||||||||
Residual solven | Methylamine not more than0.163% | Not detected | Complies | ||||||
| Methanol not more than 0.3% | Not detected | ||||||||
Acetonitrile not more than 0 0 4 1 % | Not detected | Complies
| |||||||
Isopropanol not more than 0 5 % | Not detected | ||||||||
Ethyl acetate not more than 0 . 5 % | Not detected | ||||||||
Triethylamine not more than 0.032% | Not detected | ||||||||
DMF not more than 0.088% | 0.017% | ||||||||
Residue on ignition | Not more than 0.1% | 0.035% | Complies | ||||||
Loss on drying | Not more than0.5% | 0.16% | Complies | ||||||
Assay | NLT 97.5% and NMT 102 .5% ,calculated on the dried basis | 100.6% | Complies | ||||||
Tadalafil Raw Powder – Key Product Benefits
Long-Lasting Relief of Erectile Dysfunction (ED)
Inhibits PDE-5 for up to 36 h, enabling firmer, on-demand erections with less planning.
Once-Daily Use Option
Low-dose (2.5–5 mg) daily administration provides spontaneous sexual activity without timing restrictions.
Dual Indication: BPH + ED
FDA-approved to treat both benign prostatic hyperplasia (BPH) and ED simultaneously, improving urinary flow and sexual function.
Food-Independent Absorption
Pharmacokinetics unaffected by high-fat meals, ensuring consistent clinical performance regardless of diet.
Extended Window for Intimacy
17.5 h half-life offers the longest duration among PDE-5 inhibitors, nicknamed the “week-end pill“.
What are the benefits of tadalafil?
Tadalafil bulk powder is a long-acting inhibitor with a half-life of over 18 hours, typically maintaining its effectiveness for 24 to 36 hours.
Tadalafil powder bulk is not affected by diet or lifestyle, and there are no serious contraindications or adverse reactions. Simply take it according to your doctor's instructions to achieve the desired effect and easily achieve an erection.
Key Selling Points🏭 Large-Scale Production
- Operates 10+ cGMP-compliant production lines with 100,000-level purification workshops.
- Annual output of 3,000 tons ensures reliable bulk supply for global partners.
🔍 Rigorous Quality Assurance
- SGS-certified labs equipped with HPLC, GC, and UV spectrometers for precise impurity profiling.
- Heavy metals <10ppm, microbial limits compliant with USP/EP guidelines.
Raw Material Screening: Sourced from audited suppliers with COA verification.
Synthesis & Purification: Multi-step crystallization for ≥98% purity.
Third-Party Validation: Reports from SGS/Eurofins provided with every batch.
📜 Global Certifications
- Certified by FDA, cGMP, ISO22000, and Halal/Kosher authorities.
- Compliant with REACH, WHO PQ, and regional regulations (ANVISA, COFEPRIS).
🧪 Expert R&D Support
- Custom formulations, premixed blends, and stability studies backed by 20+ senior scientists.
- Full traceability from raw materials to finished API via blockchain-enabled documentation.
Supply Chain & Logistics
Our 3,000-square-meter warehouse meets ISO22000 rules for sterilization and has distinct rooms for different sorts of goods. Climate-controlled spaces keep products stable, and well-organized stocking systems make sure that orders are filled accurately. We provide 48-hour quotations for standard orders and maintain sufficient stock levels for immediate shipping.
Global logistics partnerships with DHL, FedEx, and maritime carriers enable door-to-door delivery within 10-25 days. We offer various shipping terms including DDP and DAP arrangements. Custom packaging solutions accommodate your specific requirements while maintaining product integrity during transit.
OEM/ODM Solutions
Beyond raw material supply, we offer comprehensive manufacturing services. Our capabilities include tablet pressing, capsule filling, and powder blending for custom formulations. Private labeling services support your brand development while maintaining confidentiality agreements.
FAQs
Q: What’s the MOQ for Tadalafil Raw?
A: Sample MOQ is 1kg. Bulk discounts apply to orders above 100kg.
Q: How are you stable in transit?
Climate-controlled containers with vacuum-sealed aluminum bags and desiccants.
Q: Can you give USP-grade Tadalafil Raw Powder?
A: Yes. Certificates for our USP/EP API are available upon request.
Q: Is dosage strength adjustable?
A: Request custom strengths and blends.
Q: How does transport store the product?
A: Every shipment is sealed in moisture-proof containers and handled under temperature control.
Request a Free Sample or Quote
📧 Contact: duke@hongdaherb.com
🌐 Trusted By: 50+ pharmaceutical companies across North America, Europe, and Asia.
Why Choose out Tadalafil Raw Powder?(tadalafil powder manufacturers)
- 24/7 Technical Support: Formulation guidance and regulatory troubleshooting.
- Scalable Capacity: Ramp up production by 50% within 30 days to meet urgent demand.
