Rupatadine Fumarate

-Plant extracts

Rupatadine Fumarate
Rupatadine Fumarate

1.High quality plant extracts;
2.Organic and Natural；
3.Better stability.

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Product information

Rupatadine Fumarate API

Basic Properties

CAS No.: 182349-46-4

Rupatadine fumarate is second-generation dual antihistamine API with anti-allergy and anti-inflammatory effects, used to relieve allergic rhinitis and chronic urticaria symptoms. Off-white crystalline powder, purity ≥99.8%, complies with USP/EP/CP pharmacopoeia standards. Hermetically sealed storage at 15–25°C, strictly avoid light and moisture. Each batch provides full COA, HPLC, related substances, residual solvent and heavy metal inspection reports.

Production Technology

Fine chemical total synthetic process, multi-step purification and recrystallization under ICH Q7 quality guidelines. Strictly control impurities and chiral impurities, complete stability test data to support global pharmaceutical registration filing.

Core Advantages

Dual inhibition of histamine and platelet-activating factor, rapid onset and long duration of action, low sedative side effects. Stable supply chain for factories producing oral tablets, oral suspensions and capsules. Complete GMP audit materials and DMF supporting documents to simplify overseas registration. Flexible order plans: lab trial samples, medium batches and large industrial bulk with competitive prices.

Application Fields

  1. Prescription anti-allergy finished drugs: tablets, oral liquid capsules for allergic rhinitis, skin urticaria and pruritus treatment
  2. Special pharmaceutical raw material for anti-allergy compound preparations

Storage & Operation

Vacuum aluminum foil inner bag + fiber drum packaging, warehouse humidity controlled ≤60%, far away from high temperature and strong light. Operators wear dust-proof gloves, masks during sampling and feeding; separate storage from food, feed and cosmetic raw materials.

Our Advantages

Sufficient long-term inventory, complete analytical and registration certification documents provided. Support small trial samples and large-volume bulk wholesale cooperation.

Related raw material link: Vitamin A palmitate

Global pharmaceutical compliance standard: FDA Official Portal