China Factory Direct
|
|
| CAS number | 38092-89-6 |
| Product name | N-Methyl Desloratadine |
| 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 | Active pharmaceutical ingredient (API) for antiallergic drugs | Used as a metabolite of loratadine in the development of antihistamine drugs for treating allergic rhinitis, urticaria, and other allergic conditions |
| Pharmaceutical R&D | Reference standard for drug metabolism studies | Applied in in vitro or in vivo drug metabolism experiments to evaluate the metabolic pathways and pharmacokinetic properties of loratadine in humans |
| Pharmaceutical Analysis | Analytical reference standard | Used as a reference standard in high-performance liquid chromatography (HPLC) or mass spectrometry (MS) assays for quantitative and qualitative analysis of metabolites in biological samples |
| Test Item | Common Testing Methods | Method Overview |
|---|---|---|
| Identification | High-Performance Liquid Chromatography (HPLC) | Identify the main component by comparing retention times with reference standards under identical chromatographic conditions. |
| Identification | Infrared Spectroscopy (IR) | Determine the infrared absorption spectrum of the sample and compare it with standard spectra to confirm molecular structure and functional groups. |
| Related Substances (Impurities) | High-Performance Liquid Chromatography (HPLC) | Use gradient or isocratic elution to separate and quantitatively detect organic impurities in N-methyl chlorpheniramine (such as degradation products, synthetic intermediates), typically using a UV detector (e.g., 254 nm). |
| Content Determination | High-Performance Liquid Chromatography (HPLC) | Determine the content of N-methyl chlorpheniramine by comparing peak areas with those of known concentration reference standards using external or internal standard methods. |
| Residual Solvents | Gas Chromatography (GC) | Detect residual organic solvents used in the production process (e.g., methanol, dichloromethane, ethanol) according to ICH Q3C guidelines, using headspace or direct injection methods. |
| Dried Weight Loss | Thermogravimetric Analysis (TGA) or Constant Pressure Drying Method | Dry the sample at a specified temperature (e.g., 105°C) until constant weight is achieved, and determine the percentage mass loss due to water or other volatile components. |
| Ignition Residue | Gravimetric Method | Heat the sample to a high temperature (typically 700–800°C) and determine the amount of inorganic residue to evaluate the presence of inorganic salts or metal catalysts. |
| Heavy Metals | Atomic Absorption Spectrometry (AAS) or Inductively Coupled Plasma Mass Spectrometry (ICP-MS) | Detect harmful elements such as lead, cadmium, mercury, and arsenic according to pharmacopoeia requirements, ensuring they meet safety limits. |
| Solution Clarity and Color | Visual Colorimetry or UV-Visible Spectrophotometry | Prepare the sample into a solution of specified concentration and compare its clarity and color with standard turbidity/color solutions to assess appearance quality. |
| pH Value | pH Meter Measurement Method | Determine the acidity or alkalinity of a prepared aqueous solution using a calibrated pH meter to ensure compliance with formulation stability requirements. |
| Test Item | Specification |
|---|---|
| Appearance | Off-white solid |
| Purity | >=98.0% (HPLC) |
| Total Impurities | <=2.0% (HPLC) |
| Single Impurity | <=0.5% (HPLC) |
| Water Content (KF) | <=0.5% |
| Melting Point | 132–136°C |
| Identification (NMR) | Consistent with structure |
| Residue on Ignition | <=0.1% |
|
|
|
| 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.