High-Purity Chlorpheniramine Maleate (CAS 113-92-8): Your Reliable API Source from Kaifeng Darui Pharmaceutical
In the dynamic landscape of pharmaceutical manufacturing and research, sourcing high-quality Active Pharmaceutical Ingredients (APIs) is paramount. For formulators seeking a reliable, consistent, and high-purity supply of a cornerstone antihistamine, Chlorpheniramine Maleate (CAS: 113-92-8) stands out. Kaifeng Darui Pharmaceutical Co., Ltd. is a leading manufacturer and supplier of this essential pharmaceutical raw material, committed to exceeding industry standards in quality, reliability, and customer support. This page delves into the specifics of Chlorpheniramine Maleate, its critical applications, and why partnering with Kaifeng Darui Pharmaceutical offers a distinct strategic advantage for your business.
Understanding Chlorpheniramine Maleate (CAS 113-92-8): A First-Generation Antihistamine Powerhouse
Chlorpheniramine Maleate, identified by its Chemical Abstracts Service (CAS) number 113-92-8, is a well-established first-generation antihistamine belonging to the alkylamine class. It functions primarily as a potent H1 receptor antagonist, effectively blocking the action of histamine, a substance released by the body during allergic reactions. This mechanism forms the basis of its widespread therapeutic use.
Chemical Profile and Mechanism of Action
Chemically known as 2-[p-chloro-α-(2-dimethylaminoethyl)benzyl]pyridine maleate, Chlorpheniramine Maleate presents as a white crystalline powder. Its effectiveness stems from its ability to competitively inhibit histamine binding at H1 receptors located on effector cells in the respiratory tract, blood vessels, and gastrointestinal tract. This antagonism alleviates the classic symptoms associated with histamine release, such as:
- Sneezing
- Rhinorrhea (runny nose)
- Itchy, watery eyes
- Itching of the nose or throat
- Urticaria (hives) and skin rashes
While highly effective, as a first-generation antihistamine, Chlorpheniramine Maleate can cross the blood-brain barrier, potentially leading to sedative effects, a characteristic differentiating it from newer, second-generation antihistamines. However, its long history of use, established efficacy, and cost-effectiveness ensure its continued relevance in numerous formulations.
Key Properties and Specifications
Kaifeng Darui Pharmaceutical provides high-purity Chlorpheniramine Maleate that meets stringent quality benchmarks. Key properties typically include:
- CAS Number: 113-92-8
- Molecular Formula: C16H19ClN2·C4H4O4
- Molecular Weight: 390.86 g/mol
- Appearance: White Crystalline Powder
- Purity (Assay): Typically 99.0% (Compliant with USP/EP/BP/JP standards)
- Solubility: Freely soluble in water, soluble in ethanol and chloroform.
Our commitment ensures that the Chlorpheniramine Maleate API you receive adheres to the highest pharmacopeial standards, guaranteeing consistency and performance in your final product formulations. Sourcing pharmaceutical raw material like Chlorpheniramine Maleate requires a partner focused on these critical details.
Diverse Applications and Therapeutic Uses of Chlorpheniramine Maleate
The versatility and established efficacy of Chlorpheniramine Maleate (CAS 113-92-8) make it a vital component in a wide range of pharmaceutical products targeting allergic and cold-related symptoms.
Allergy Relief Medications
This is the primary application. Chlorpheniramine Maleate is a cornerstone ingredient in over-the-counter (OTC) and prescription medications designed to treat symptoms of allergic rhinitis (hay fever), seasonal and perennial allergies, and other allergic conditions like urticaria. Its rapid onset of action provides quick relief from debilitating allergy symptoms.
Combination Cold and Flu Products
Due to its effectiveness in alleviating runny nose, sneezing, and itchy/watery eyes, Chlorpheniramine Maleate is frequently included in multi-symptom cold and flu remedies. It is often combined with decongestants (like pseudoephedrine or phenylephrine), analgesics/antipyretics (like acetaminophen or ibuprofen), and sometimes cough suppressants (like dextromethorphan) to provide comprehensive relief.
Veterinary Applications
The antihistaminic properties of Chlorpheniramine Maleate are also utilized in veterinary medicine, primarily for treating allergic reactions, pruritus (itching), and anaphylactic reactions in animals, particularly dogs and cats, under veterinary guidance.
Research and Development
As a well-characterized molecule, Chlorpheniramine Maleate continues to be relevant in pharmaceutical research, potentially serving as a reference compound or being investigated for novel delivery systems or therapeutic combinations. Access to a reliable supply of high-purity Chlorpheniramine from Kaifeng Darui Pharmaceutical is crucial for researchers.
Why Choose Kaifeng Darui Pharmaceutical for Chlorpheniramine Maleate (CAS 113-92-8)?
Selecting an API supplier is a critical decision impacting product quality, regulatory compliance, and supply chain stability. Kaifeng Darui Pharmaceutical Co., Ltd. emerges as the preferred partner for sourcing Chlorpheniramine Maleate (CAS 113-92-8) for several compelling reasons:
Unwavering Commitment to Quality (E-E-A-T Focus)
Quality is not just a metric; it's the foundation of our operations. Kaifeng Darui Pharmaceutical operates under strict quality management systems, adhering to Good Manufacturing Practices (GMP). Our facilities are regularly audited, and we hold relevant certifications (e.g., ISO certifications), ensuring our Chlorpheniramine Maleate API meets the highest international standards (USP, EP, BP, JP). Rigorous in-process controls and final product testing guarantee purity, consistency, and compliance batch after batch.
Manufacturing Excellence and Capacity
Our state-of-the-art manufacturing facilities are equipped with modern technology and scalable infrastructure. This allows us to produce Chlorpheniramine Maleate efficiently and consistently, meeting diverse volume requirements from R&D quantities to large commercial batches. We invest continuously in process optimization to ensure cost-effectiveness without compromising the integrity of this vital antihistamine API.
Reliability and Supply Chain Security
In today's global market, supply chain reliability is non-negotiable. Kaifeng Darui Pharmaceutical understands this critical need. We maintain robust inventory management systems and have established resilient logistics networks to ensure timely and dependable delivery of Chlorpheniramine Maleate (CAS 113-92-8) worldwide. Partnering with us minimizes supply chain risks and ensures continuity for your manufacturing operations.
Expertise and Dedicated Customer Support (E-E-A-T Focus)
Our team comprises experienced chemists, engineers, and pharmaceutical professionals with deep expertise in API manufacturing and regulatory affairs. We provide comprehensive technical support, including detailed documentation (Certificates of Analysis, MSDS, DMF availability information upon request) to facilitate your formulation development and regulatory submissions. Kaifeng Darui Pharmaceutical is more than a supplier; we are a collaborative partner invested in your success.
Technical Specifications and Quality Assurance for Chlorpheniramine Maleate
Kaifeng Darui Pharmaceutical is committed to transparency and providing detailed technical information for our Chlorpheniramine Maleate (CAS 113-92-8).
Purity and Impurity Profiling
We consistently achieve high-purity Chlorpheniramine Maleate (typically 99.0%). Our rigorous quality control includes advanced analytical techniques (like HPLC) for assay determination and comprehensive impurity profiling. We control impurities stringently according to pharmacopeial monographs and ICH guidelines, ensuring the safety and efficacy of the final drug products manufactured using our API.
Compliance with Pharmacopeial Standards
Our Chlorpheniramine Maleate API is manufactured to comply with the latest editions of major pharmacopeias, including:
- United States Pharmacopeia (USP)
- European Pharmacopoeia (EP)
- British Pharmacopoeia (BP)
- Japanese Pharmacopoeia (JP)
We provide documentation confirming compliance upon request, supporting your global regulatory needs.
Rigorous Testing Protocols
Each batch of Chlorpheniramine Maleate (CAS 113-92-8) undergoes a full panel of tests in our certified QC laboratory. This includes identification, assay, loss on drying, residue on ignition, heavy metals, related substances (impurities), and residual solvents, ensuring every shipment meets predefined specifications.
Packaging and Storage
We offer flexible packaging options suitable for pharmaceutical raw materials, typically including multi-layer bags within fiber drums, designed to protect the product's integrity during transit and storage. Recommended storage conditions (typically cool, dry, dark place) are clearly indicated to maintain product stability.
The Critical Importance of High-Purity Chlorpheniramine Maleate API
Using a high-purity Chlorpheniramine Maleate API, such as that supplied by Kaifeng Darui Pharmaceutical, is crucial for several reasons:
- Efficacy: Higher purity directly correlates with predictable therapeutic effects. Impurities can interfere with the drug's mechanism or reduce its effective concentration.
- Safety: Certain impurities can have toxicological effects. Strict control over impurity profiles, as practiced by Kaifeng Darui, minimizes patient safety risks.
- Stability: Pure compounds are generally more stable, leading to better shelf life for both the API and the final drug product.
- Regulatory Compliance: Health authorities worldwide mandate stringent purity requirements for APIs. Using high-purity material facilitates smoother regulatory submissions and approvals.
- Manufacturing Consistency: Consistent API purity leads to more predictable and reproducible results during the drug product manufacturing process, reducing batch failures and deviations.
Choosing Kaifeng Darui Pharmaceutical for your Chlorpheniramine Maleate (CAS 113-92-8) needs ensures you receive an API that meets these critical purity and quality demands.
Partnering with Kaifeng Darui Pharmaceutical: A Strategic Advantage
Beyond supplying a high-quality antihistamine API, partnering with Kaifeng Darui Pharmaceutical offers significant strategic benefits:
- Long-Term Reliability: Build your production plans on the foundation of a stable and reliable supply of Chlorpheniramine Maleate.
- Quality Assurance Partnership: Benefit from our robust quality systems and transparent documentation, simplifying your internal QA processes and regulatory filings.
- Technical Collaboration: Leverage our technical expertise for formulation support or troubleshooting.
- Competitive Pricing: Our efficient manufacturing processes allow us to offer competitive pricing for premium quality Chlorpheniramine Maleate (CAS 113-92-8).
- Streamlined Procurement: Experience responsive customer service and efficient order processing.
We aim to be more than just a supplier; we strive to be an integral part of your success story by providing exceptional pharmaceutical raw materials like Chlorpheniramine Maleate.
Request Your Quote for Chlorpheniramine Maleate (CAS 113-92-8) Today!
Ensure the quality and reliability of your pharmaceutical products by sourcing high-purity Chlorpheniramine Maleate (CAS 113-92-8) from a trusted global leader. Kaifeng Darui Pharmaceutical Co., Ltd. is ready to meet your API needs with exceptional quality, reliable supply, and dedicated support.
Contact our expert team today to discuss your specific requirements, request technical documentation, or receive a competitive quote for Chlorpheniramine Maleate.
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