Mycophenolate mofetil Bulk Supply for Industrial Use
China Factory Direct
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| CAS number | 128794-94-5 |
| Product name | Mycophenolate mofetil |
| Stock | Stock readily available; annual supply capacity exceeding 1,000 tons. |
| Grade | Pharmaceutical Grade |
| Packaging | 25KG/bag500KG/bag1000KG/bag |
| Sample | Test Samples Available (Click to Request Samples) |
| COA | View COA |
| Price | Get Quote |
| Supply Type | Bulk / Contract manufacturing / OEM |
| Shipping | FCL / LCL available |
| Payment Terms | Support FOB \ CIF \ EXW quotations, and accept Letter of Credit (L/C). |
| Manufacturer | Greenrock Chemical(China Factory) |
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Documents We Provide for Mycophenolate mofetil
Post-sale: Full documentation is provided.
To request documents, please contact us via email at sales@GRchemical.com.
Bulk Mycophenolate mofetil Supplier from China
17+ years in chemical exports.Fully compliant, reliable supply.Your B2B partner in bulk chemical procurement.
Industrial Applications of Mycophenolate mofetil
| Industry | Application | Process |
|---|---|---|
| Pharmaceuticals | Immunosuppressant for prevention of organ transplant rejection | Used as a prodrug of mycophenolic acid; hydrolyzed by esterases in vivo to release the active moiety, mycophenolic acid, which inhibits lymphocyte proliferation |
| Pharmaceuticals | Treatment of autoimmune disorders (e.g., lupus nephritis) | Orally administered and metabolically activated in the gastrointestinal tract and liver; selectively inhibits the de novo purine synthesis pathway in T and B lymphocytes |
Manufacturing Quality Control of Mycophenolate mofetil
| Test Item | Common Testing Methods | Method Overview |
|---|---|---|
| Assay | High-Performance Liquid Chromatography (HPLC) | Utilizes a reverse-phase C18 column with a mobile phase consisting of phosphate buffer and organic solvent, quantifying the main component using a UV detector (e.g., 254 nm or 215 nm), in accordance with pharmacopoeial standards. |
| Related Substances/Impurity Analysis | HPLC Gradient Elution Method | Employs a high-sensitivity HPLC system with gradient elution to separate and quantify known impurities (e.g., mycophenolic acid, degradation products), typically controlling limits according to ICH Q3A/B guidelines. |
| Residual Solvents | Gas Chromatography (GC) with Headspace Sampling | According to ICH Q3C, utilizes a capillary column and FID detector with headspace sampling technique to determine residual organic solvents (e.g., methanol, ethyl acetate) from the manufacturing process. |
| Loss on Drying | Drying Method or Thermogravimetric Analysis (TGA) | Dries the sample to constant weight at a specified temperature (e.g., 105°C) and calculates the percentage of mass loss to assess moisture and volatile substance content. |
| Residue on Ignition | High-Temperature Ashing Method | The sample is incinerated in a muffle furnace at high temperature (600–800°C), and the residual inorganic mass is weighed to evaluate the total level of inorganic impurities. |
| Heavy Metals | Atomic Absorption Spectroscopy (AAS) or ICP-MS | After sample digestion, measures residual elements such as lead, cadmium, mercury, and arsenic using atomic absorption or inductively coupled plasma mass spectrometry, in compliance with pharmacopoeial heavy metal limits. |
| Dissolution | Dissolution Apparatus + HPLC Detection | Simulates in vivo conditions by measuring the amount of drug released over time in a specified medium (e.g., pH 6.8 buffer) to evaluate consistency in bioavailability of the formulation. |
| Water Content | Karl Fischer Titration | Directly titrates water content in the sample using Karl Fischer reagent via volumetric or coulometric methods, suitable for quality control of moisture-sensitive active pharmaceutical ingredients. |
| Crystal Form Analysis | X-Ray Powder Diffraction (XRPD) | Determines crystal structure through characteristic diffraction peaks to ensure consistency of the active pharmaceutical ingredient’s crystal form, preventing potential impacts on stability or bioavailability due to polymorphic differences. |
| Microbial Limits | Pharmacopoeial Microbiological Testing Methods | Includes total aerobic microbial count, mold and yeast count, and testing for specified control organisms (e.g., Escherichia coli, Salmonella spp.) to ensure compliance with requirements for sterile or non-sterile dosage forms. |
Technical Specifications of Mycophenolate mofetil
| Test Item | Specification |
|---|---|
| Appearance | White to almost white powder or crystals |
| Purity | >=98.0% (HPLC) |
| Water Content (KF) | <=0.5% |
| Melting Point | 124–128°C |
| Total Impurities | <=2.0% |
| Single Impurity | <=0.5% |
| Heavy Metals | <=20 ppm |
| Residue on Ignition | <=0.1% |
Specifications vary by industry. Reach out to our technical experts for a COA tailored specifically to your application. Email:selse@GRchemical.com
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Download COA of Mycophenolate mofetil
| CAS/Product ID | *Required fields | |
| Lot/Batch Number | *Required fields | |
NMR Spectra of Mycophenolate mofetil
Packaging of Mycophenolate mofetil
Industrial Mycophenolate mofetil Procurement FAQ
1. How do you ensure product quality consistency?
We rely on a mature China-based manufacturing system and implement strict batch control and quality inspection for every shipment. Our production process complies with ISO 9001 standards, and a COA is provided for each batch to ensure consistent and reliable quality.
2. Do you offer competitive pricing for bulk orders?
Yes, as a China-based manufacturer and bulk supplier, we provide tiered pricing based on order volume. We support FOB and CIF quotations, as well as L/C payment terms for large transactions to meet international trade requirements.
3. Can you support large-volume or long-term supply?
We have stable production capacity and a well-established supply chain, enabling continuous bulk supply. We support ton-level and container-level orders, as well as long-term cooperation projects.
4. What is your typical lead time?
For in-stock products, shipment can be arranged within 1–3 days. For bulk packaging or customized orders, lead time depends on the specific quantity and production schedule.
5. What documents do you provide?
We can provide complete documentation upon request, including COA, SDS, TDS, and other compliance certificates, meeting industrial procurement and export requirements.
6. Can you customize product specifications or packaging?
Yes, we support customization of parameters such as purity, impurities, residual solvents, and heavy metals. We also offer various bulk packaging options, including 25kg bags, drums, and IBC tanks, suitable for industrial applications and transportation.
7. What shipping options do you support?
We support both FCL (Full Container Load) and LCL (Less than Container Load) shipments, and can flexibly arrange logistics solutions based on order size to meet bulk chemical export needs.
8. Do you provide technical or application support?
Yes, we provide basic application guidance and technical support based on industry experience to help customers optimize product usage.
9. How do you handle compliance and export regulations?
We are familiar with international trade and export regulations, ensuring all products comply with relevant requirements. We also provide complete documentation to support smooth customs clearance and global delivery.
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