China Factory Direct
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| CAS number | 2628280-40-8 |
| Product name | PF-07321332 |
| Stock | Stock readily available; annual supply capacity exceeding 1,000 tons. |
| Grade | Pharmaceutical 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 |
|---|---|---|
| Pharmaceuticals | Antibody-drug conjugate intermediates | Chemical synthesis for biopharmaceutical manufacturing |
| Biotechnology | Monoclonal antibody production | Used as a key intermediate in cell culture processes |
| Pharmaceutical R&D | New drug development | Applied in structural modification of targeted therapeutics |
| Test Item | Common Testing Methods | Method Overview |
|---|---|---|
| Assay | High-Performance Liquid Chromatography (HPLC) | Utilizes a reverse-phase C18 column and a UV detector (approximately 262 nm) to determine the content of the active ingredient via external standard or internal standard methods, ensuring compliance with pharmacopoeial standards. |
| Related Substances (Impurities) | High-Performance Liquid Chromatography (HPLC) | Employs a gradient elution program to separate and detect process-related impurities and degradation products; qualitative identification is based on relative retention times, and quantification is performed via peak area normalization or external standard methods. |
| Residual Solvents | Gas Chromatography (GC) | According to ICH Q3C guidelines, detects organic solvents used during manufacturing (e.g., methanol, ethanol, acetone, dichloromethane) using headspace sampling to enhance sensitivity. |
| Water Content | Karl Fischer Titration | Performed using either volumetric or coulometric methods to precisely measure water content in the active pharmaceutical ingredient, controlling it within specified limits to prevent degradation. |
| Crystal Form Analysis | X-ray Powder Diffraction (XRPD) | Determines whether the crystal form of PF-07321332 conforms to the reference form (e.g., Form I) to ensure physical stability and consistent bioavailability. |
| Particle Size Distribution | Laser Diffraction Particle Size Analysis (LDL) | Measures particle size distribution (D10, D50, D90) using wet or dry dispersion methods; influences dissolution rate and stability of the final formulation. |
| Chiral Purity | Chiral High-Performance Liquid Chromatography (Chiral HPLC) | Uses a chiral stationary phase column to detect potential enantiomeric impurities, ensuring stereochemical purity meets requirements. |
| Melting Point | Capillary Melting Point Determination | Measures the melting temperature range of the compound as a physical property for identification, aiding in assessing purity and consistency of crystal form. |
| Ultraviolet Absorption Characteristics | Ultraviolet-Visible Spectrophotometry (UV-Vis) | Measures the maximum absorption wavelength (λmax) and molar absorptivity in a specified solvent for qualitative and auxiliary quantitative analysis. |
| Microbial Limits | Microbial Limit Test | Performs tests in accordance with pharmacopoeial requirements for total aerobic microbial count, total mold and yeast count, and specified control organisms (e.g., Escherichia coli) to ensure microbiological safety. |
| Heavy Metals | Inductively Coupled Plasma Mass Spectrometry (ICP-MS) | Detects residual heavy metal elements such as lead, cadmium, arsenic, and mercury, in compliance with ICH Q3D limits for elemental impurities. |
| Test Item | Specification |
|---|---|
| Appearance | White to off-white solid |
| Purity | >=98.0% (HPLC) |
| Total Impurities | <=2.0% (HPLC) |
| Single Impurity | <=0.5% (HPLC) |
| Water Content (KF) | <=0.5% |
| Identification (NMR) | Consistent with reference standard |
| Residue on Ignition | <=0.1% |
| Odor | Characteristic, not objectionable |
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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.