99% Tiopronin API Of GMP Manufacturer
Tiopronin (also known as Thiopronin) is a sulfhydryl‑containing compound derived from the amino acid glycine. It acts as a reducing agent, forming soluble mixed disulfides with cystine and preventing the formation of cystine kidney stones in patients with cystinuria. Additionally, tiopronin has hepatoprotective and free-radical-scavenging properties, making it useful for liver disease and as a mucolytic adjunct in certain respiratory conditions.
Our Tiopronin Raw Material is manufactured in a GMP‑compliant facility with strict control over related substances, residual solvents, and particle size.
It is suitable for oral tablets (100 mg, 200 mg, 300 mg, branded as Thiola®), compounded capsules, and, less commonly, ophthalmic solutions for certain indications.
Why Import Tiopronin API From Us
First, Strict GMP guidelines guarantee high quality.
Our Tiopronin API is produced in accordance with cGMP guidelines.
Therefore, this API is suitable for producing finished dosages for human consumption, especially for pharmacy compounding.
Second: Steady supply with stable stock
OCTAGONCHEM is a supplier that has a rotating stock quantity of 100~200 Kilos.
Stock status may vary slightly due to order quantities submitted by regular customers, but we ensure quick supply by leveraging our flexible production plans.
"Tiopronin API: Essential for Cystinuria Treatment and Compounding"
Manufacturer Documents Download
Tiopronin Bulk Powder is a white to off-white powder with its characteristic odor.
As an organic sulfur compound, it doesn’t smell good or pleasant.
Tiopronin is soluble in water or ethanol and very slightly soluble in chloroform or ether.
Meanwhile, as a reducing molecule, tiopronin quickly becomes rancid when exposed to high temperatures and sunlight.
Applications:
Tiopronin API is used in the following pharmaceutical and compounding applications:
Oral tablets (immediate release) – for the prevention of cystine kidney stones in patients with cystinuria (a rare genetic disorder). Typical maintenance dose: 200–600 mg three times daily (adjusted to reduce urinary cystine levels below 200–300 mg/L). Branded as Thiola® (US) and Thiola EC® (EU, enteric‑coated).
Compounded oral capsules – for patients who cannot swallow tablets, require custom dosing (e.g., 50 mg, 150 mg, 250 mg), or need to avoid excipients in commercial products.
Compounded oral suspensions (flavored) – for pediatric patients with cystinuria (rare but occurs in children) or geriatric patients with dysphagia.
Hepatoprotective adjunct (off‑label) – for alcoholic liver disease, non‑alcoholic steatohepatitis (NASH), and certain types of hepatitis (limited evidence; used in some countries).
Compounded ophthalmic solutions (investigational) – for the treatment of corneal cystine crystals in cystinosis (a different disorder; tiopronin has been used off‑label as a topical thiol agent).
Research formulations for mucolytic applications – due to its ability to break disulfide bonds in mucus (similar to N‑acetylcysteine).
Product Name: Tiopronin APIs (Tiopronina, 硫普罗宁)
Cas Number: 1953-02-2
Molecular Formula: C5H9NO3S
Molecular Weight: 163.20 g/mol
Chemical Name: [2-(2-sulfanylpropanoylamino)acetic acid; N-(2-Mercaptopropionyl)glycine]
HS Code: 2930909099 (Other organic sulfur compounds-其他有机硫化合物)
Suitability to be shipped by air as common goods: suitable. It is safe to be shipped by air as common goods.
Grade: Pharma-Grade
Purity or Assay: 99%
Standards: Current Enterprise/USP Standards
Manufacturer Certificates available: GMP/ISO
Manufacturer Documents Available: COA/DMF/MSDS
Supply Capability: 1000+ KG per year
MOQ: 1KG
Lead Time: 5~6 days for quantities less than 50KG, 3~4 days for orders less than 10KG.
Stock Status: Over 100KG
Shipping Temperature: Room temperature
Armazenar: Room temperature
Technical Data:
Clarity and color of solution: Clear and colorless
Melting point: 96~99°C
Loss on drying: NMT0.5%
Residue on ignition: NMT0.1%
Sulfate: NMT0.048%
Related substances: NMT 2.0%
As: NMT2ppm
Fe: NMT5ppm
Assay: NLT98.5%
Why Choose Us As Your Tiopronin API Supplier?
As a key player in China’s pharmaceutical industry, OCTAGONCHEM is excited to offer you a great opportunity to import Tiopronin active pharmaceutical ingredients (APIs) from China at affordable prices and help you reduce your purchasing costs. But that’s not all; our uncompromising commitment to higher quality, customer satisfaction, and innovation has positioned us as your preferred manufacturer of Tiopronin API.
Below is why:
#1. Strict QC and 0-Tolerance for quality issues
At OCTAGONCHEM, we are proud of our quality guarantee policy. If you encounter any quality issues, you will receive a full refund or a free exchange.
We dare to keep that promise because of our strict quality control measures.
#2. Proven expertise within the API industry
With decades of experience in the pharmaceutical export circle, OCTAGONCHEM has established itself as a reliable supplier. Our successful business relations with top pharmaceutical companies reflect our dedication to delivering excellence to all our customers.
#3. Top-notch manufacturing facilities
Our Tiopronin API production facilities are newly built and equipped with the latest intelligent technology, enabling us to operate at the highest standards in the current pharmaceutical industry. Our advanced facilities also give us an advantage during official audits by the USFDA, TGA, and similar authorities.
Choosing OCTAGONCHEM as your supplier of tiopronin means you will be free from quality issues and have a stable, uninterrupted supply for your manufacturing schedules.
We look forward to any inquiries you may have as we begin our successful relationship.
FAQs About Our Tiopronin API
#Q1. What measures do you take to ensure the quality of your Tiopronin API?
A1. As a GMP manufacturer, ensure Tiopronin API quality by adhering to GMP guidelines.
We demonstrate our high quality through testing, primarily using three methods to ensure the quality of our tiopronin raw material.
For Purity: HPLC or LC-Mass
We test its purity on every batch before export.
We must ensure the quality is good before materials leave our warehouse.
Our purity requirement for bulk tiopronin is a minimum of 98.5%. Usually, the actual results exceed 99%.
For Structure: 1HNMR
We don’t test 1H NMR on every batch, but we can do so for you. If you need it
You can also use HPLC to identify the material by comparing it with the RS testing spectrum. Once the retention times of the peaks correspond, it is the same material.
For heavy metals: Elemental Analysis and atomic absorption
We don’t usually perform elemental analysis for this product, as neither the FDA nor other pharmacopeias require it.
We will test such requirements at a third-party testing institution if you have them.
#Q2. Can you supply Tiopronin APIs for compounding pharmacies?
A2. Absolutely yes.
We provide high-quality Tiopronin API specifically for compounding applications.
#Q3. What is your MOQ for Tiopronin API?
A3: Normally, the MOQ from the GMP factory starts at one standard packing unit: 25 kg. However, to better serve our pharmacy customers, we are willing to repackage 1 kg as our MOQ.
If you have an even smaller demand, less than 1kg, please get in touch with us directly to see if we can sample accordingly.
#4. What is your lead time for Tiopronin API?
A4. The average lead time for our tiopronin API is around 4~5 days for standard packing units, say 25kg, 50kg, 100kg, etc.
If you need repackaging into 1kg, 5kg, etc., it will take about 6~8 days.
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