China Factory Direct
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| CAS number | 147127-20-6 |
| Product name | Tenofovir |
| 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) |
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 |
|---|---|---|
| Pharmaceuticals | Antiviral agent for the treatment of HIV infection and chronic hepatitis B | Used to inhibit viral reverse transcriptase activity, thereby suppressing viral replication; typically administered in combination with other antiviral agents to enhance efficacy and reduce the risk of resistance development |
| Pharmaceutical Manufacturing | Active pharmaceutical ingredient (API) production | Applied as an API, synthesized via a defined chemical route involving steps such as phosphorylation and esterification, yielding oral or injectable dosage forms |
| Biotechnology | Research tool | Applied in laboratory settings to investigate viral replication mechanisms and support the development of novel antiviral strategies |
| Clinical Trials | New drug development and evaluation | Used as a reference compound or as part of combination regimens during new drug development to assess efficacy and safety against various viral infections |
| Test Item | Commonly Used Testing Method | Method Overview |
|---|---|---|
| Content Determination | High-Performance Liquid Chromatography (HPLC) | An HPLC method using a reversed-phase C18 column, phosphate buffer-methanol as the mobile phase, and a UV detector to measure the peak area of the main component. The content is calculated using the external standard method. This method is suitable for the quantitative analysis of Tenofovir in raw materials and pharmaceutical formulations. |
| Related Substances (Impurities) | High-Performance Liquid Chromatography (HPLC) | A gradient or isocratic elution method to separate degradation products and synthetic impurities. The impurity levels are calculated by comparing with reference standards or by the self-reference method, controlling both total and individual impurity limits. |
| Residual Solvents | Gas Chromatography (GC) | According to ICH guidelines, headspace sampling-gas chromatography is used to detect organic solvents (e.g., methanol, dichloromethane, N,N-dimethylformamide) employed during manufacturing. Quantitation is performed using an FID detector. |
| Water Content | Karl Fischer Titration | An electrochemical titration method for determining water content in samples. It can be performed using either volumetric or coulometric methods and is suitable for precise determination of trace moisture in active pharmaceutical ingredients (APIs). |
| Crystal Form Identification | X-Ray Powder Diffraction (XRPD) | Analyzes the position and intensity of characteristic peaks in the sample's diffraction pattern to determine whether its crystal form conforms to the standard (e.g., amorphous or specific crystalline form). Used for polymorph control. |
| Particle Size Distribution | Laser Diffraction Particle Size Analysis | The sample is dispersed in a liquid or gas medium, and particle size distribution is measured based on laser scattering. This method is used to evaluate the dissolution properties of APIs and the uniformity of formulations. |
| pH Value | pH Meter Method | A 1% (w/v) aqueous solution of Tenofovir is prepared, and the pH is directly measured using a calibrated pH meter to control acidity or alkalinity. |
| Heavy Metals | Inductively Coupled Plasma Mass Spectrometry (ICP-MS) or Sulfide Colorimetric Method | The ICP-MS method offers high sensitivity and can simultaneously determine multiple heavy metal residues such as lead, cadmium, mercury, and arsenic. The colorimetric method is suitable for limit testing, offering simplicity but lower sensitivity. |
| Microbial Limits | Microbial Limit Test | Conducted according to the requirements of the Chinese Pharmacopoeia or USP, including tests for total aerobic microbial count, total mold and yeast count, and specified microorganisms (e.g., Escherichia coli, Salmonella spp.) to ensure microbiological safety. |
| Content Uniformity/Dissolution (Formulation) | HPLC Method | Used to determine the content uniformity or dissolution of Tenofovir tablets. Simulates gastrointestinal conditions to evaluate drug release behavior and batch consistency. |
| Test Item | Specification |
|---|---|
| Appearance | White solid |
| Purity | >=98.0% |
| Total Impurities | <=2.0% |
| Single Impurity | <=0.5% |
| Water Content (KF) | <=0.5% |
| Melting Point | 148–152°C |
| Optical Rotation | -21° to -19° (c=1, in methanol) |
| Identification (NMR) | Conforms to reference standard |
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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.