Tadalafil Powder Bulk

1. Name: Tadalafil
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

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Product Description

Professional Supplier of Pharmaceutical-Grade Tadalafil Powder

Hongda Tadalafil Powder Advantages

1. Very High Purity: ≥99.5% (HPLC)

2. Stable Crystal Form: There is just one α-crystal form, which makes solubility and bioavailability consistent.

3. Low Residual Solvent: ≤5ppm, which is what GMP and ICHQ3C say it should be

4. Quality control for the whole chain: a professional staff does research and development and third-party testing reports

5. Certifications: The US Food and Drug Administration (FDA), Organic Food, Kosher ISO, HALAL, HACCP, and GMP.

Tadalafil Powder Manufacturer:(Where to buy tadalafil powder?)

Shaanxi Hongda Phytochemistry Co., Ltd., a major manufacturer and supplier of tadalafil powder bulk, ensures the provision of pharmaceutical-grade tadalafil powder that satisfies global standards with its strong R&D skills, advanced cGMP certified facilities, and tight quality control. With significant industry knowledge and bespoke services, we are ideally positioned to meet the diverse needs of pharmaceutical sector clients.

What is Tadalafil Powder?

Bulk tadalafil powder is a strong PDE5 inhibitor that works well for treating male sexual problems like erectile dysfunction and benign prostatic hyperplasia. Tadalafil powder of pharmaceutical grade has a high level of purity and consistent quality, which makes it perfect for different dosage forms. We are a trusted supplier around the world, and we supply all the paperwork you need, including full COAs and test reports, to make sure you get the best products.

Tadalafil Powder

Product Specification

roduct 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
Conclusion			Conforms to USP2022 specification

Tadalafil has several benefits:

1. Relaxing the smooth muscle of blood vessels: Tadalafil powder bulk can block PDE5 in a certain method, which increases levels of cyclic guanosine monophosphate (cGMP) and keeps blood vessels open.

2. Controlling blood flow: When taken in the proper amounts, bulk tadalafil can promote blood flow in a certain area, which is good for the health of functional foods and health supplements.

3. studies tool: Tadalafil bulk powder is frequently utilized in pharmacological, metabolic, and cell signaling pathway studies as a benchmark for PDE5 inhibitors.

Applications

The pharmaceutical business mostly uses tadalafil powder for the following reasons:

1. Making pills that men can use to help with erectile dysfunction.

2. Creating treatments for pulmonary arterial hypertension.

3. Drug development and clinical trials.

Why Choose Us?

1. Technical Support:

Shaanxi Hongda has 24 years of experience in progestin and PDE5 inhibitor R&D, providing a full-chain technical service including formulation optimization, process scale-up, and stability assessment.

Equipment

2. Testing Reports:

All our products come with four major reports: HPLC, GC-MS, ¹H-NMR, thermogravimetric analysis, and microbial limits. All reports are issued by a third-party laboratory in a GMP-certified facility and can be directly used in product registration materials.

Laboratory

3. Professional Team:

Shaanxi Hongda's laboratory comprises an interdisciplinary team of experts in pharmacy, chemistry, process engineering, and regulatory compliance, providing rapid response to formulation, process, and regulatory inquiries.

Team

4. After-Sales Service:

24/7 customer service hotline, providing logistics tracking, quality traceability, technical training, and formulation improvement suggestions to ensure a worry-free process for clients from R&D to market launch.

OEM service

FAQs:

1. How can I obtain the product purity and testing reports?

Each batch comes with an HPLC report (≥99.5% purity), GC-MS solvent residue test, ¹H-NMR structural confirmation, and microbial limit report, all issued by a third-party laboratory in a GMP-certified facility. These reports are directly applicable to registration materials.

2. Does it contain any additives or fillers?

100% pure natural tadalafil crystalline powder, free of any fillers, sweeteners, or preservatives.

3. What formulations is it suitable for?

Particle size ≤12µm, compatible with various processes such as capsule filling, tablet compression, functional beverage emulsification, and skincare matrix emulsification.

4. What is the minimum order quantity?

Bulk order starts at 1kg. We can also provide 25kg moisture-proof paper drums or customized small packaging (300g-5kg) according to customer requirements.

5. What should I do if the received batch does not meet the quality requirements?

Upon receiving a complaint, our technical support team will investigate within 48 hours. Once confirmed, we will provide a replacement of the same batch or a full refund, along with a quality analysis report.

6. What is the compliance status of tadalafil raw materials in the European and American markets?

We have received FDA GRAS notification and EU Novel Food approval, meeting the safety and quality requirements of the US FDA and EU EFSA for PDE5 inhibitor raw materials. They can be used in functional foods, health supplements, and pharmaceutical research and development.