Active Pharmaceutical Ingredient – Manufacturer and Bulk Supplier in Maharashtra for Pharmaceutical Formulation Development And Manufacture
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Cetirizine Hydrochloride (CAS 83881-52-1) is a selective peripheral H1-receptor antagonist and active metabolite of hydroxyzine. Unlike first-generation antihistamines, cetirizine has minimal CNS penetration due to its zwitterionic structure at physiological pH, resulting in negligible sedation at therapeutic doses. It provides rapid, 24-hour duration relief from allergic rhinitis, seasonal hay fever, chronic urticaria, and allergic conjunctivitis, making it one of the world's most consumed OTC antihistamine APIs.
Cetirizine Hydrochloride API quality is characterised by its zwitterionic form stability — the hydrochloride salt ensures consistent dissolution behaviour across pH ranges in bioequivalence testing. Key quality parameters include chiral purity (racemic Cetirizine is pharmacologically active; levocetirizine is the R-enantiomer) confirmed by chiral HPLC, and N-oxide impurity control below 0.1%. For paediatric syrup formulations, micronised grade (D90 <50 µm) ensures uniform dose suspension.
Swapnroop supplies Cetirizine Hydrochloride API in racemic form (standard commercial product) and as pharmaceutical-grade material compliant with IP/BP/USP pharmacopeial specifications. Our Aurangabad WHO-GMP facility maintains high-volume production for this fast-moving OTC API, with consistent impurity profiling, chiral purity confirmation, and competitive bulk pricing for high-frequency tablet and syrup formulation orders.
Cetirizine Hydrochloride API is supplied in 25 kg double-polyethylene-lined fiber drums with desiccant and sealed against moisture. Fine particle grade for suspension formulations is supplied in 10 kg HDPE jars with anti-static inner liner. Stored at 25°C below with RH <65%.
Get Bulk QuoteThe CAS number for Cetirizine Hydrochloride is 83881-52-1. It is a Active Pharmaceutical Ingredient used in pharmaceutical pharmaceutical formulation development and manufacture.
Cetirizine Hydrochloride is classified as a Active Pharmaceutical Ingredient. It is used in pharmaceutical formulation development and manufacture and is an established API in both domestic Indian and international pharmaceutical markets.
Cetirizine Hydrochloride API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%, complete related substances profiling, and residual solvent analysis per ICH Q3C guidelines.
Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Larger volumes may be available from existing stock.
Yes, Swapnroop provides complete DMF-grade documentation for Cetirizine Hydrochloride API including Certificate of Analysis (CoA), MSDS, impurity profile, residual solvent certificate, and regulatory filing support for USFDA, EMA, and CDSCO submissions.
Swapnroop Drugs and Pharmaceuticals is a trusted Cetirizine Hydrochloride API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Cetirizine Hydrochloride API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Cetirizine Hydrochloride API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Cetirizine Hydrochloride API pricing, samples, and sourcing support.