When pharmaceutical buyers source an established antihistamine API, they usually care less about promotional claims and more about three practical questions:
Is the API quality stable?
Can the supplier support regulatory documents?
Is the material suitable for formulation and commercial evaluation?
For companies working with allergy, cold, cough, and antihistamine formulations, Chlorpheniramine Maleate API CAS 113-92-8 remains a widely used and commercially important pharmaceutical raw material.
Huzhou Ureda Pharmaceutical Co., Ltd. supplies Chlorpheniramine Maleate API with GMP and DMF support for international pharmaceutical manufacturers, distributors, CDMOs, and formulation developers.
Product Snapshot
| Item | Information |
|---|---|
| Product Name | Chlorpheniramine Maleate |
| CAS No. | 113-92-8 |
| Product Category | Antihistamine API |
| Quality Standard | USP |
| Documentation | GMP / DMF available |
| Typical Packing | 25 kg/drum |
| Application | Antihistamine, cold, allergy, and respiratory formulations |
Chlorpheniramine Maleate is commonly used in oral solid dosage forms, combination cold medicines, allergy products, and other antihistamine-related pharmaceutical formulations.
Why Chlorpheniramine Maleate Still Has Strong Market Demand
Chlorpheniramine Maleate is not a new molecule, but it remains highly relevant because it is widely recognized, cost-effective, and suitable for many finished dosage formulations.
It is commonly evaluated by customers involved in:
- Allergy medicine manufacturing
- Cold and cough formulations
- Antihistamine tablets or capsules
- Combination respiratory products
- Generic medicine development
- API distribution and resale
- Regulated and semi-regulated market supply
For mature antihistamine APIs, buyers usually prioritize consistent quality, reliable supply, competitive pricing, and complete documentation.
USP Quality Profile
A recent batch of Chlorpheniramine Maleate API was tested according to USP requirements. The batch showed strong impurity control and full compliance with the tested standard.
| Test Item | Specification | Result |
|---|---|---|
| Optical Rotation | -0.10° to +0.10° | 0.00° |
| Infrared Identification | Corresponds to reference standard | Complies |
| HPLC Identification | Retention times correspond to standard | Complies |
| Impurity B | ≤0.2% | Not detected |
| Impurity C | ≤0.1% | Not detected |
| Impurity E | ≤0.1% | 0.02% |
| Impurity F | ≤0.1% | Not detected |
| Any Other Unspecified Impurity | ≤0.10% | 0.03% |
| Total Impurities | ≤0.5% | 0.05% |
| Loss on Drying | ≤0.5% | 0.1% |
| Residue on Ignition | ≤0.2% | <0.2% |
| Assay | 98.0%–102.0% | 100.0% |
| Packaging and Storage | Tight, light-resistant containers | Complies |
This quality profile is useful for customers who need to evaluate batch suitability, impurity control, assay performance, and supplier reliability before placing a sample or commercial order.
GMP and DMF Support
For pharmaceutical manufacturers, API sourcing is not only about price. Documentation support is often essential for supplier approval and registration preparation.
For Chlorpheniramine Maleate API, Ureda Pharma can support customers with:
- GMP documentation
- DMF support
- COA
- Specification
- MSDS
- Technical document support
- Export documentation
- Packaging and storage information
This makes the product suitable for customers working on formulation manufacturing, vendor qualification, dossier preparation, and commercial sourcing.
What Buyers Should Confirm Before Ordering
Before purchasing Chlorpheniramine Maleate API, buyers are advised to confirm:
Quality Standard
The referenced batch is tested according to USP. Customers should confirm whether USP meets their internal or target market requirements.
Document Requirement
Some customers only need COA and specification, while others may require GMP, DMF, MSDS, questionnaire, or supplier qualification documents.
Quantity and Packing
The typical packing is 25 kg/drum. For sample or commercial inquiries, buyers should provide the required quantity and destination country.
Storage Condition
The product should be preserved in tight, light-resistant containers to maintain quality during storage and transportation.
Product Summary
| Product | CAS No. | Standard | Documents | Application |
|---|---|---|---|---|
| Chlorpheniramine Maleate API | 113-92-8 | USP | GMP / DMF available | Antihistamine and cold formulations |
Why Source from Huzhou Ureda Pharmaceutical?
Huzhou Ureda Pharmaceutical Co., Ltd. supports global customers with APIs, pharmaceutical raw materials, and specialty ingredients. For Chlorpheniramine Maleate API, we focus on practical sourcing support, including availability check, document review, quotation, and export coordination.
We welcome inquiries from:
- Pharmaceutical manufacturers
- Generic drug companies
- Finished dosage producers
- API distributors
- CDMOs
- Sourcing and regulatory teams
Contact Us for Chlorpheniramine Maleate API
If you are looking for Chlorpheniramine Maleate API CAS 113-92-8 with GMP and DMF support, please contact us for availability, COA, specification, and quotation.
Huzhou Ureda Pharmaceutical Co., Ltd.
Contact: Owen Lee
Email: sales@uredapharm.com
Website: www.uredapharm.com
WhatsApp: +86-18270717590
FAQ
What is Chlorpheniramine Maleate API?
Chlorpheniramine Maleate API is an antihistamine pharmaceutical raw material used in allergy, cold, cough, and respiratory formulations.
What is the CAS number of Chlorpheniramine Maleate?
The CAS number of Chlorpheniramine Maleate is 113-92-8.
Is GMP documentation available?
Yes. GMP support is available for Chlorpheniramine Maleate API.
Is DMF support available?
Yes. DMF support is available depending on customer requirements and project evaluation.
What quality standard is available?
The referenced batch was tested according to USP.
What is the typical packing?
Typical packing is 25 kg/drum.
