Ambroxol HCl

Ambroxol HCl

Paramètre Spécifications
Nom du produit Ambroxol HCl
Numéro CAS 23828-92-4
Formule moléculaire C13H18Br2N2O·HCl
Poids moléculaire 414.56 g/mol
Apparence Poudre cristalline blanche à blanc cassé
Essai (HPLC) 99.0% – 101.0% (calculated on dried basis)
Solubilité Soluble in water, ethanol; slightly soluble in acetone
Colis Fût en fibre de 25 kg avec double revêtement en polyéthylène

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Ambroxol HCl Structure

Synonymes : Ambroxol hydrochloride, trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, 23828-92-4, Mucosolvan, Ambroxol HCl API

Ambroxol HCl is the hydrochloride salt of ambroxol, a synthetic mucoactive agent derived from the natural alkaloid vasicine. As a pharmaceutical ingredient, it is supplied as a white crystalline powder with a defined particle size distribution, meeting pharmacopeial standards for oral and parenteral formulations.

In the global API market, Ambroxol HCl is a mature, high-volume product used in respiratory care. Its primary role is to improve mucociliary clearance and ease expectoration in conditions such as bronchitis and COPD. The compound is also investigated for its local anesthetic and antioxidant properties, though its core application remains in cough and cold preparations.

Product Highlights

  • High Purity: Assay 99.0%–101.0% by HPLC, suitable for oral solid dosage and liquid formulations.
  • Regulatory Support: CEP and US DMF available for streamlined registration.
  • Consistent Particle Size: D90 typically ≤ 50 µm, ensuring blend uniformity.
  • Large-Scale Capacity: Annual output exceeding 200 MT from our dedicated facility.
  • Full Documentation: COA, MSDS, TDS, and stability data provided with each lot.
  • Fast Turnaround: Stock items ready for shipment within 3-5 business days.

Applications & Formulation Use

  • Oral solid dosage forms: tablets, capsules, and granules for cough and cold relief.
  • Liquid formulations: syrups, drops, and suspensions for pediatric and adult use.
  • Injection: sterile ambroxol HCl for hospital use in acute respiratory conditions.
  • Combination products: with antibiotics or bronchodilators to enhance therapeutic outcomes.
  • Research: reference standard for analytical method development and bioequivalence studies.

Quality Specifications (QC Tests)

Test Item Spécifications
Identification IR and HPLC retention time match reference standard
Perte au séchage ≤ 0,5%
Résidu au feu ≤ 0,11 TP3T
Métaux lourds ≤ 20 ppm
Organic Impurities Meets EP/USP requirements
Limites microbiologiques Total aerobic count ≤ 1000 CFU/g; absence of specified pathogens

Bulk Supply & Ordering

  • Conditionnement : 25 kg fiber drum with double polyethylene liner, or as per customer request.
  • MOQ: 25 kg.
  • Délai d'exécution : 3-5 business days for stock items.
  • Documentation : COA, MSDS, TDS, and stability data available upon request.
  • Storage: Store in a cool, dry place, protected from light.

Foire aux questions

What is the minimum order quantity (MOQ) for Ambroxol HCl?

Our MOQ is 25 kg. For smaller quantities, please contact our sales team to discuss your specific needs.

What is the delivery time?

For stock items, delivery is typically within 3-5 business days after order confirmation.

Can you provide a COA and sample?

Yes, we provide a COA for each lot. Samples are available upon request and can be shipped within 1-2 days.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

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