Ibuprofen lysinate Bulk Supply for Industrial Use
China Factory Direct
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| CAS number | 57469-76-8 |
| Product name | Ibuprofen lysinate |
| 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 Ibuprofen lysinate
Post-sale: Full documentation is provided.
To request documents, please contact us via email at sales@GRchemical.com.
Bulk Ibuprofen lysinate Supplier from China
17+ years in chemical exports.Fully compliant, reliable supply.Your B2B partner in bulk chemical procurement.
Industrial Applications of Ibuprofen lysinate
| Industry | Application | Process |
|---|---|---|
| Pharmaceuticals | Nonsteroidal anti-inflammatory drug (NSAID) for relieving mild to moderate pain, fever, and inflammation (e.g., headache, toothache, arthritis) | Used as a water-soluble prodrug of ibuprofen; salt formation with lysine enhances solubility and bioavailability, facilitating formulation into rapid-release dosage forms such as oral solutions and injectables |
| Pharmaceutical Manufacturing | Drug intermediate or active pharmaceutical ingredient (API) | Produced via salt formation between racemic ibuprofen and L-lysine in a suitable solvent, followed by crystallization, drying, and other purification steps |
Manufacturing Quality Control of Ibuprofen lysinate
| Test Item | Common Testing Methods | Method Overview |
|---|---|---|
| Appearance | Visual Inspection and Physical Measurement | Observe the appearance of the sample (e.g., white or off-white crystalline powder), odor, solubility, etc., to ensure compliance with the appearance specifications outlined in the Chinese Pharmacopoeia or internal quality control standards. |
| Identification | Infrared Spectroscopy (IR) | Determine the infrared absorption spectrum using an infrared spectrophotometer, compare it with the reference standard of racemic ibuprofen lysinate, and confirm that the characteristic peaks match for chemical structure identification. |
| High-Performance Liquid Chromatography (HPLC) | Under specific chromatographic conditions (e.g., C18 column, methanol-water/buffer as mobile phase), identify the presence of the main component by comparing retention time with the reference standard. | |
| Content Determination | High-Performance Liquid Chromatography (HPLC) | Use external standard or internal standard methods to determine the peak area of racemic ibuprofen lysinate in the sample via HPLC. Compare it with the reference solution to calculate the content, typically required to be not less than 98.0% (on an anhydrous basis). |
| Related Substances | High-Performance Liquid Chromatography (HPLC) | Use gradient or isocratic elution HPLC system to detect possible impurities in the sample (e.g., free ibuprofen, lysine, oxidation products, degradation products), compare the peak area of impurities with the main peak area, and control the limits of single impurity and total impurities. |
| Solution Clarity and Color | Visual Colorimetry or UV-Visible Spectrophotometry | Dissolve the sample in a specified solvent (e.g., water or ethanol), visually inspect for clarity and absence of obvious color, or use a spectrophotometer at a specific wavelength (e.g., 450 nm) to measure absorbance, ensuring compliance with pharmacopoeia limits. |
| Residual Solvents | Gas Chromatography (GC) | Use headspace or direct injection GC method to detect residual organic solvents (e.g., ethanol, acetone, ethyl acetate) from the production process. Control the levels of each solvent according to ICH Q3C standards within permissible limits. |
| Moisture Content | Karl Fischer Titration (KF) | Determine the moisture content using Karl Fischer reagent through potentiometric or coulometric titration. Control the moisture level within a specified range (e.g., ≤0.5%) to ensure product stability. |
| Heavy Metals | Atomic Absorption Spectrometry (AAS) or ICP-MS | After ashing or digestion of the sample, use atomic absorption or inductively coupled plasma mass spectrometry to determine the content of heavy metals such as lead, cadmium, mercury, and arsenic. Ensure compliance with pharmacopoeia limits (e.g., ≤20 ppm). |
| Particle Size Distribution (if applicable) | Laser Diffraction or Microscopy | For powdered formulations, measure particle size distribution to ensure compliance with process requirements, affecting solubility and formulation uniformity. |
| Optical Rotation (or Specific Rotation) | Automatic Polarimeter Method | Racemic ibuprofen lysinate is a racemic compound and theoretically has no optical activity, so the result should be close to 0°. If an abnormal optical rotation is detected, it may indicate the presence of optical isomer contamination, used to assess the racemic purity. |
| pH Value (in Aqueous Solution) | pH Meter Method | Prepare a solution of specified concentration and measure the pH value using a calibrated pH meter to ensure it falls within the controlled range (e.g., 5.0–7.5), reflecting the acid-base stability of the product. |
| Microbial Limit | Microbial Count and Controlled Organism Testing | Conduct aerobic microbial count, mold and yeast count, and controlled organism testing (e.g., Escherichia coli) according to Chinese Pharmacopoeia General Chapter 1105 and 1106 to ensure compliance with microbial standards for non-sterile bulk drug substances. |
Technical Specifications of Ibuprofen lysinate
| Test Item | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Purity | >=98.5% |
| Water Content (KF) | <=0.5% |
| Melting Point | 120.0 - 124.0 °C |
| Total Impurities | <=1.5% |
| Single Impurity | <=0.5% |
| Residue on Ignition | <=0.1% |
| Heavy Metals | <=10 ppm |
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 Ibuprofen lysinate
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| Lot/Batch Number | *Required fields | |
Packaging of Ibuprofen lysinate
Industrial Ibuprofen lysinate 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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