China Factory Direct
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| CAS number | 137234-62-9 |
| Product name | Voriconazole |
| Stock | Stock readily available; annual supply capacity exceeding 1,000 tons. |
| Grade | Pharmaceutical GradeIndustrial GradeSpecialty Grade |
| Packaging | 25KG/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) |
Based on current marketvolatility and material availability.
17+ years in chemical exports.Fully compliant, reliable supply.Your B2B partner in bulk chemical procurement.
| Industry | Application | Process |
|---|---|---|
| Pharmaceutical Industry | Antifungal Agent | Used to treat severe systemic fungal infections |
| Chemical Industry | Intermediate | Serves as an intermediate in the synthesis of other antifungal agents |
| Pharmaceutical Industry | Drug Formulation | Applied in the preparation of oral tablets, intravenous injections, and other dosage forms |
| Test Item | Common Testing Method | Method Overview |
|---|---|---|
| Content Determination | High-Performance Liquid Chromatography (HPLC) | Using a reverse-phase C18 chromatographic column with an acetonitrile-buffer system (e.g., phosphate buffer) as the mobile phase. The ultraviolet detector measures at approximately 254 nm wavelength, and external standard method is used to calculate the main component content. It has strong specificity and high precision, suitable for quantitative analysis of active pharmaceutical ingredients and formulations. |
| Related Substances (Impurities) | High-Performance Liquid Chromatography (HPLC) | Gradient elution is employed to separate voriconazole and its degradation products or synthetic intermediates. Detection is performed at about 254 nm. This method can effectively detect potential impurities (such as N-oxide, isomers, etc.), complying with ICH impurity study requirements. |
| Dissolution | UV-Visible Spectrophotometry (UV-Vis) or HPLC | Commonly used to evaluate dissolution behavior of tablets or dry suspensions. A dissolution apparatus (e.g., paddle method) is used in media such as pH 4.5 acetate buffer or 0.1 mol/L hydrochloric acid. Sampling is followed by UV or HPLC measurement of dissolved concentration to assess release performance of the formulation. |
| Residual Solvents | Gas Chromatography (GC) | In accordance with the Chinese Pharmacopoeia or ICH Q3C guidelines, headspace injection-capillary gas chromatography is applied to detect residual organic solvents from the production process (e.g., methanol, ethanol, dichloromethane, N,N-dimethylformamide). FID detector ensures solvent residues meet safety limits. |
| Moisture Content | Karl Fischer Titration | Used to determine moisture content in active pharmaceutical ingredients. It includes volumetric or coulometric methods, providing high accuracy to avoid moisture impact on stability. Usually, moisture should be controlled within certain limits (e.g., ≤1.0%). |
| Polymorphic Analysis | X-ray Powder Diffraction (XRPD) | Used to identify different polymorphic forms of voriconazole (e.g., known A, B, C forms), ensuring polymorphic consistency that affects solubility and bioavailability. It is an important means for solid-state form control. |
| Particle Size Distribution | Laser Diffraction Particle Size Analysis | Used to control particle size in dry suspensions or inhalation formulations. Ensures proper dispersion and absorption characteristics in the body, typically controlling D90 within specific ranges. |
| Microbial Limits | Microbial Limit Test | Conducted according to General Chapters 1105 and 1106 of the Chinese Pharmacopoeia, measuring aerobic bacterial count, mold and yeast count, as well as controlled bacteria (e.g., Escherichia coli, Salmonella), to ensure non-sterile preparations meet microbial standards. |
| Related Substances (Chiral Impurities) | Chiral High-Performance Liquid Chromatography (Chiral HPLC) | If chiral centers are involved in impurities, chiral stationary phase columns can be used to separate enantiomers and evaluate optical purity. Suitable for specific process control requirements. |
| Content Uniformity | HPLC or UV Method | Used for quality control of low-dose tablets. Individual units are measured separately to calculate content uniformity (CU), determining whether each tablet’s content is consistent, meeting pharmacopoeial standards (e.g., ±15% variation). |
| Test Item | Specification |
|---|---|
| Appearance | White crystalline solid |
| Purity | >=98.0% (LC-MS) |
| Total Impurities | <=2.0% |
| Single Impurity | <=0.5% |
| Water Content (KF) | <=0.5% |
| Melting Point | 136.0 to 140.0 °C |
| Optical Rotation | -62.0 to -58.0 deg (c=1, in methanol) |
| Identification (NMR) | Conforms to reference spectrum |
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| CAS/Product ID | *Required fields | |
| Lot/Batch Number | *Required fields | |
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.