Sildenafil Mesylate Powder

Sildenafil Mesylate raw powder CAS1308285-21-3 GMP factory supply

1: What Is Sildenafil Mesylate Powder & Specifications and Core Pharmaceutical Applications

1.1 What is sildenafil mesylate powder API

Sildenafil mesylate is a PDE5 inhibitor; making a salt by mixing sildenafil free base with methanesulfonic acid creates another version of sildenafil to get around patent issues. Other PDE5 inhibitor medicines include sildenafil citrate, tadalafil, avanafil, water-soluble tadalafil, alcohol-soluble tadalafil, tadalafil derivatives, undetected tadalafil analogs like Jinyangjian, Xinyangjian, Huanyangjian, 520, SX, and vardenafil HCl. Plant PDE inhibitors like epimedium extract, Ginseng extract, and Kaempferia parviflora.

PDE5 inhibitors like sildenafil mesylate could be combined with dapoxetine; dapoxetine does not belong to PDE inhibitors; dapoxetine is the only oral medicine for premature ejaculation. It belongs to the class of SSRI inhibitors(Selective Serotonin Reuptake Inhibitors).

1.2 Sildenafil mesylate API Chemical Specifications & CAS Number
1.2 .1 API name: Sildenafil mesylate
1.2 .2 Appearance: White crystal powder
1.2 .3 Taste: Sildenafil mesylate, compared to the tadalafil series, sildenafil mesylate tastes bitter
1.2 .4 Specification: 98%-102% powder according to USP, EP
1.2 .5 CAS No.: 1308285-21-3
1.2 .6 Molecular Formula: C23H34N6O7S2
1.2 .7 Molecular Weight: 570.68
1.2 .8 Certificates: GMP, cGMP, CEP, CDE, FDA, Organic, Kosher, ISO, HALAL, FSSC, DMF
1.2 .9 Testing partner of independent lab: Wuxi AppTec, Merieux
1.2 .10 Test Method: HPLC, UV-visible spectrophotometry
1.2 .11 Storage method:15～25℃, RH＜60%, store away from light
1.2 .12 Export only, welcome research labs and professionals

1.3 Pharmaceutical Applications (5 Benefits of sildenafil mesylate powder for Health)
1.3.1 Avoid patent conflicts involving sildenafil citrate and other PDE inhibitors like tadalafil, etc.
1.3.2 Effectively relieve symptoms of benign prostatic hyperplasia (BPH)
1.3.3 Fast-acting to help you perform better
1.3.4 Applicable for issues linked to pulmonary arterial hypertension
1.3.5 Boost physical stamina and build greater self-confidence

2: FAQ about sildenafil mesylate powder

2.1 Sildenafil Mesylate Powder Order Quantity
10g: Free samples for your lab test and even body test
1kg: Trial order to test our secure door-to-door delivery service
25kg–200kg: Ideal for you to check our stable product supply; new batches are in stock
200kg–500kg: We will reship free of charge if goods get lost. We are your reliable partner
500kg and above: Each batch comes with an HPLC test report. We can meet your specific requirements on impurities and particle size, and we’ll be your ideal finished product partner.

2.2 Sildenafil mesylate powder packaging
10g: Packed in aluminum foil bags with inner transparent PE bags to prevent leakage
1kg: Packed in aluminum foil bags with inner transparent PE bags to prevent leakage
25kg–200kg: Blue tamper-proof HDPE plastic drums and fiber drums available
200kg–500kg: Blue tamper-proof HDPE drums or fiber drums, shipped with forklift pallets
500kg and above: Custom labels and customized packaging are acceptable as per your request
Carton boxes are also common packaging
Because of customs policy, sometimes commercial packaging is needed

2.3 Sildenafil mesylate powder delivery channel and lead time
Post office route: Around 5kg max, transit time about 15 days. Works well for Indonesia, Turkey, and South Africa. Slow transit, but customers don’t need to handle customs clearance themselves.
Express options: FedEx, UPS, DHL, 7 days around.
Air freight: We supply all customs clearance documents for you.
Truck/train transport: Suitable for Central Asian countries.
Sea freight: Only available for large bulk orders.
Our exclusive chemical shipping line: Door-to-door delivery available worldwide.

2.4 How to Use sildenafil mesylate powder
2.4.1 Take 45~90 mg for erectile dysfunction. Most users shouldn’t take more than one dose within 24 hours
2.4.2 For benign prostatic hyperplasia (BPH), 22.5~45 mg at a fixed time before bedtime daily.
2.4.3 Sildenafil Mesylate 30 mg, three times daily to treat primary pulmonary hypertension
2.4.4 Dosage & Usage, Warnings: See Sildenafil Citrate

2.5 Sildenafil mesylate powder available formulations are as follows:
Hard capsules
Film-coated tablets
Hard capsules & tablets in plastic bottles
Hard capsules & tablets in single blister packs
Hard capsules & tablets in multi-blister packs
Oral dissolvable films (fast-dissolving oral films)
Oral suspensions
Oral syrup drinks
Honey-based preparations
Coffee formulations
Medicated wine (can be mixed with whiskey)
Gummy candies (e.g., bear-shaped gummies)

2.6 Sildenafil mesylate powder: take-work time, lasting time compared to other PDE5 inhibitors
2.6.1 Sildenafil mesylate powder: takes effect in 30–60 mins, peak blood concentration at 1 hour, the lasting time is 4–6 hours, half-life is 4 hours
2.6.2 Vardenafil: takes effect in 15–30 mins, peak blood concentration at 1 hour, the lasting time is 4–6 hours, half-life is 4 hours
2.6.3 Avanafil: fastest acting, takes effect in around 15 mins, peak blood concentration in 30–45 mins, the lasting time is 6 hours, half-life is 6 hours
2.6.4 Tadalafil: takes effect in 30–45 mins, peak blood concentration at 2 hours, the lasting time is up to 36 hours, half-life is 18 hours

2.7 Sildenafil mesylate powder Side Effects & Usage Tips
2.7.1 Side effects
Small side effects include flushing, headache, and nasal congestion; classical blue vision similar to sildenafil citrate. If these side effects occur, reduce the dose to 22.5 mg (equal to 25 mg sildenafil citrate).
2.5.2 Drug interactions
Do not take together with nitrates (nitroglycerin, isosorbide mononitrate, etc.), as this may cause life-threatening low blood pressure.
2.7.2 Avoid grapefruit juice
Grapefruit juice slows sildenafil mesylate metabolism, raising blood drug levels and side effect risks. Do not drink it while using this product.
2.7.3 Alcohol notes
Avoid alcohol after taking this medicine. Alcohol significantly reduces efficacy and worsens hypotension and dizziness. This differs from tadalafil; please take note.

2.8 Solubility of sildenafil mesylate powder
2.8.1 Water
It dissolves better than sildenafil citrate. It makes a clear liquid when mixed with a small amount of water, but turns cloudy if you use a high concentration. Mostly used for oral suspensions and water-based oral liquids.
2.8.2 Ethanol
Only a small amount can dissolve in alcohol. It works fine in small doses for medicinal wine, coffee, and honey drinks. Do not use it in high-concentration mixes.
2.8.3 Food-grade PEG400
Dissolves very well and makes a completely clear liquid. Commonly used to make suspensions, syrups, and soft candies.
2.8.4 Propylene Glycol
It has good dissolving power. People often mix it with PEG400 to make liquid products with high drug content and keep the mixture stable.
2.8.5 Glycerin
It dissolves moderately well. Mainly used for honey syrups and gentle oral drinks.

2.9 Legal status of sildenafil mesylate
The legal status of sildenafil mesylate may vary by country. In many regions, it is classified as a prescription medication, while in others, it can be obtained over the counter. Always verify local regulations regarding the purchase and use of sildenafil mesylate to ensure compliance with the law.
We can supply GMP registration documents and customs clearance papers to support your marketing business.

3: Cooperation advantages about us 

We have focused on PDE5 inhibitors since 2011 and have solid expertise in this area. We are glad to develop exclusive customized products to support you and achieve win-win cooperation.
With over 10 years of experience, we have completed more than 120 clinical trials covering over 16,000 participants and provided reliable supply services to clients from more than 10 countries.

3.1 Factory Production Control Introduction
Our modern factory meets cGMP, ISO22000, and FSSC22000 standards. All production lines are separated from sensitive chemicals and follow the latest 2026 GMP Class D cleanroom rules.
Our internal standards are stricter than USP43 and EP10. Every batch goes through three high-precision molecular sieve filters to remove unknown analogues and residues.
We use LC-MS/MS testing equipment to control genotoxic impurities and solvent residues like ethanol, methanol, and ethyl acetate. All test results stay below detection limits, providing pure and safe products for export and registration.

3.2 Lab and Quality Control System 
We specialize in quality control for APIs and adopt a dual inspection system: in-house laboratory testing plus independent third-party testing.
Our in-house lab is fully equipped to conduct comprehensive tests, including HPLC, MS, GC, GC-MS, LCMS-ELSD, HPLC-ELSD, chirality tests, and nuclear magnetic resonance testing. Every batch undergoes full internal testing before shipment.
We also cooperate with three authoritative third-party labs, namely WuXi AppTec, Pony Testing, and Merieux. Objective and compliant test reports are provided to support clients’ global registration and sales.

3.3 Quality control of every batch(Below is an HPLC test report of tadalafil just for you referrence).
Every batch of products undergoes full HPLC quality testing, with stable and controllable test results. We can provide complete original test report images for you before you place an order, not COAs, since COAs can be modified. You can trace every step of our product quality.

3.4 We own a complete industrial chain covering intermediates, APIs, formula development, and finished products.
3.4.1 We work with tablet OEM clients. We can customize formulas and coating colors together.
3.4.2 Our mainstream hard capsules are size 00 and 0. We use high-speed automatic production machines.
3.4.3 We support custom blister molds and custom color boxes.
3.4.4 We have professional dissolution technology. It fits coffee oral liquid, honey oral liquid, and oral wine.
3.4.5 We make gummies in custom shapes, like bear gummies.
3.4.6 Custom oral dissolvable films (oral strips) can be made to order.
3.4.7 We provide bottle packaging. Customers can get personalized colorful labels.
3.4.8 We have many compound formulas for choice.
We do not suggest mixing PDE5 active ingredients.
We do not suggest mixing PDE5 active ingredients like sildenafil citrate, Sildenafil Mesylate, avanafil, water-soluble tadalafil, alcohol-soluble tadalafil, tadalafil derivative, undetected tadalafil analogs like Jinyangjian, Xinyangjian, 520, SX, and vardenafil HCl. But it is good combined with herbal PDE5 inhibitors like epimedium extract, Ginseng extract, and Kaempferia parviflora.
The best match is tadalafil plus dapoxetine. Formulas added with plant extracts also perform well.

3.5 We are well-versed in relevant laws, regulations, and customs policies worldwide.
We specialize in the men’s PDE5 inhibitor area, and we are familiar with local regulations and patents.
The clients should follow their local laws. Based on clients’ demands and local policies, we can develop derivative products and undetectable PDE5 inhibitors.
We also provide product registration services for our clients.

4: In our opinion, PDE5 inhibitors belong to a niche market. Their patents are expiring one after another, yet these pharmaceutical products must still be sold in compliance with local laws and regulations. We are looking for professional partners in this field. If you don’t have relevant experience yet, partnering with us will make you an expert in this industry.

References

1: Verified tadalafil vendor in Chemicalbook from:
https://www.chemicalbook.com/manufacturer/shaanxi-linkyou-biotechnology-25552/
2: A professional PDE5 finished products producer
https://www.linkyougroup.com
3: Title: Sildenafil 4.0—Integrated Synthetic Chemistry, Formulation and Analytical Strategies
Source: PMC (NIH U.S. Government open academic library)
Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC8071249/
4: Title: Chemistry Review for Sildenafil Oral Suspension NDA (Salt Form & Cosolvent Compatibility Data)
Source: FDA AccessData
5: Link: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203109Orig1s000ChemR.pdf
Title: CYP3A4-Mediated Metabolism of Sildenafil: Modulation by Natural CYP3A Inhibitors Including Grapefruit Furanocoumarins
Source: NIH PMC full open access
Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10747454/
6: Title: CYP3A4-Mediated Metabolism of Sildenafil: Modulation by Natural CYP3A Inhibitors Including Grapefruit Furanocoumarins
Source: NIH PMC full open access
Link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10747454/
7: Title: Sildenafil: Pharmacology, Salt Form Differences, Clinical Dosing and Adverse Effects
Source: NCBI StatPearls (U.S. federal public medical database)
Link: https://www.ncbi.nlm.nih.gov/books/NBK558978/