Ambroxol HCl

Ambroxol HCl

Параметр Технические характеристики
Название продукта Ambroxol HCl
Номер CAS 23828-92-4
Молекулярная формула C13H18Br2N2O·HCl
Молекулярная масса 414.56 g/mol
Внешний вид Кристаллический порошок от белого до небелого цвета
Анализ (ВЭЖХ) 99.0% – 101.0% (calculated on dried basis)
Растворимость Soluble in water, ethanol; slightly soluble in acetone
Упаковка 25 kg fiber drum with double polyethylene liner

Ambroxol HCl Structure

Синонимы: 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.

Основные особенности продукта

  • Высокая степень очистки: Assay 99.0%–101.0% by HPLC, suitable for oral solid dosage and liquid formulations.
  • Поддержка в области нормативно-правового регулирования: 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 Технические характеристики
Идентификация IR and HPLC retention time match reference standard
Потери при сушке ≤ 0,51 TP3T
Остаток после прокаливания ≤ 0,11 TP3T
Тяжелые металлы ≤ 20 ppm
Органические примеси Meets EP/USP requirements
Microbial Limits Total aerobic count ≤ 1000 CFU/g; absence of specified pathogens

Bulk Supply & Ordering

  • Упаковка: 25 kg fiber drum with double polyethylene liner, or as per customer request.
  • Минимальный объем заказа: 25 kg.
  • Время выполнения: 3-5 business days for stock items.
  • Документация: COA, MSDS, TDS, and stability data available upon request.
  • Storage: Store in a cool, dry place, protected from light.

Frequently Asked 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

send us your specification for a quotation.

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Room,5-0203, Unit 5, Beiyuanmen Street,Xi'an,Shaanxi,China

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