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Hydroxyzine Hydrochloride is a first-generation antihistamine with anxiolytic, sedative, antiemetic, and antipruritic properties. It belongs to the piperazine class of antihistamines and is widely used to manage allergic reactions, anxiety, nausea, and tension.
At Bluepill Express, Hydroxyzine Hydrochloride API is manufactured under WHO-GMP, ISO 9001:2015, and cGMP-compliant facilities, ensuring superior quality, purity, and consistency. Our product is supplied globally for the formulation of tablets, capsules, and syrups used in the treatment of allergic conditions and anxiety disorders.
Therapeutic Applications
- Management of anxiety and tension in psychoneurotic conditions
- Relief from allergic skin reactions such as urticaria and dermatitis
- Adjunct therapy in sedation and anesthesia
- Prevention and control of nausea and vomiting
- Treatment of itching (pruritus) caused by allergic conditions
Mechanism of Action
Hydroxyzine Hydrochloride works by blocking histamine H1 receptors in peripheral tissues and the central nervous system (CNS). It also exhibits anticholinergic and sedative effects by suppressing subcortical areas of the CNS. The result is reduced histamine-mediated allergic responses, anxiety relief, and sedation.
Key Technical Specifications
- Chemical Name: Hydroxyzine Hydrochloride
- Molecular Formula: C₂₁H₂₇ClN₂O₂·HCl
- Molecular Weight: 447.4 g/mol
- CAS Number: 2192-20-3
- Appearance: White to off-white crystalline powder
- Assay (on dried basis): ≥ 99.0% (HPLC)
- Melting Point: 169°C – 173°C
- pH (1% solution): 4.0 – 5.0
- Loss on Drying: ≤ 1.0%
- Residue on Ignition: ≤ 0.1%
- Heavy Metals: ≤ 10 ppm
- Solubility: Freely soluble in water and alcohol
- Storage: Store below 25°C, protected from light and moisture
Pharmacopoeial Standards
- Complies with: IP / BP / USP / EP standards (as required)
- Manufacturing Standards: WHO-GMP / ISO / cGMP Certified
- Analytical Methods: HPLC, UV spectrophotometry, IR spectroscopy, KF
Pharmacological Category
- Therapeutic Class: Antihistamine / Anxiolytic / Sedative
- ATC Classification: N05BB01
- Drug Category: Piperazine derivative antihistamine
Dosage Form Applications
Hydroxyzine Hydrochloride API from Bluepill Express is ideal for formulation into:
- Tablets & Capsules (10 mg, 25 mg, 50 mg)
- Oral Syrups & Solutions (for pediatric and adult use)
- Injectable Preparations (where applicable)
Our API ensures excellent stability, flowability, and compressibility properties for seamless formulation development.
Documentation Support
Available regulatory documents:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data
- Method of Analysis (MOA)
- DMF (under confidentiality agreement)
Packaging & Export Options
- Available Pack Sizes: 100 g | 500 g | 1 kg | 5 kg | 10 kg
- Packaging Type: Double polyethylene bags inside HDPE drums or aluminum containers
- Labeling: Product name, batch number, manufacturing/expiry date, net weight, storage conditions, and manufacturer details
- Shelf Life: 36 months (under recommended conditions)
- Transportation: Non-hazardous per IATA & IMDG classification
Safety & Handling
- Precaution: Avoid contact with skin, eyes, and clothing.
- Protection: Use gloves, masks, and protective eyewear.
- Disposal: Dispose of material in accordance with local regulations.
- Spillage: Absorb with inert material and dispose safely.
Advantages of Bluepill Express Hydroxyzine Hydrochloride API
- WHO-GMP & ISO certified manufacturing
- High purity with global pharmacopoeial compliance
- Consistent particle size for reliable formulation
- Exported to Africa, Asia, and Latin America
- Backed by complete regulatory and documentation support
