99% Ambroxol Hydrochloride API Of GMP Factory
Ambroxol Hydrochloride is a well‑established, centrally acting mucolytic agent that has become a staple in respiratory medicine across more than 50 countries. It is the active metabolite of bromhexine but offers superior efficacy, longer half‑life, and better tolerability.
Our ambroxol hydrochloride API is synthesized in a cGMP‑compliant facility using a validated multistep route. Each batch is tested for purity (≥ 99% by HPLC), related substances (including bromohexine and other process impurities), residual solvents (including methanol and ethyl acetate), heavy metals, and microbial limits.
For compounding pharmacies preparing pediatric oral solutions, preservative‑free formulations, or high‑dose capsules for off‑label neurological use, we provide the CoA, impurity profile, and excipient compatibility data required for USP <795> compliance.
Why Import Ambroxol Hydrochloride API From Us?
#1. High-quality Ambroxol Hydrochloride API With GMP/DMF
Our ambroxol hydrochloride API is a GMP-approved pharmaceutical ingredient suitable for compounding and medicine manufacturing.
Our purity is over 99%, with single impurities controlled below 0.1% and total impurities under 0.3%.
We can also provide DMF documents for your MOH registration.
#2. Low MOQ with Free Samples for Testing
Typically, our GMP-approved APIs start with a standard pack size of 10 KG or 25 KG.
Still, to accommodate the needs of compounding pharmacies and small- to medium-sized medicine manufacturers, we offer low MOQs for trial orders to get the ball rolling.
We can start at 100 grams for trial orders.
Free Ambroxol API samples are available for testing if you are unsure about our quality.
Ambroxol Hydrochloride API Applications and Specifications
Manufacturer Documents Download
Applications:
For Pharmaceutical Manufacturers
Ambroxol API is formulated into a wide range of finished dosage forms:
Oral solutions and syrups (3 mg/mL, 6 mg/mL, 15 mg/mL) – the most common pediatric and adult liquid formulations, often fruit‑flavored.
Tablets (30 mg, 60 mg, 75 mg) – immediate‑release and sustained‑release versions.
Effervescent tablets (30 mg, 60 mg) – for convenient dissolution in water.
Injection ampoules (15 mg/2 mL) – for hospital use in severe respiratory distress.
Sustained‑release capsules (75 mg) – for once‑ or twice‑daily dosing.
High‑dose capsules (100‑300 mg) – emerging for neurological repurposing (Gaucher, Parkinson’s).
For Compounding Pharmacies
Ambroxol is a high‑demand compounding ingredient, particularly for:
Pediatric preservative‑free oral suspensions (e.g., 3 mg/mL, 6 mg/mL) for children with sensitivities to commercial syrup preservatives.
Custom‑strength liquids (e.g., 7.5 mg/mL) for weight‑based dosing in infants.
High‑dose capsules (100‑200 mg) for off‑label neurological protocols (Gaucher, Parkinson’s) where commercial doses are inadequate.
Veterinary oral solutions for dogs, cats, and horses with respiratory conditions.
Sugar‑free or dye‑free preparations for patients with excipient allergies.
Product Name: Ambroxol hydrochloride APIs (盐酸氨溴索)
Appearance: A white to off-white powder
Solubility: Sparingly soluble in water, soluble in methanol, practically insoluble in methylene chloride
Cas Number: 23828-92-4
Molecular Formula: C13H19Br2ClN2O
Molecular Weight: 414.56 g/mol
Chemical Name: trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride
HS Code: 2922199090 (Other amino alcohols, their ethers, esters, and their salts-其他氨基醇及其醚、酯和它们的盐)
Suitability to be shipped by air/sea/rail as common goods: suitable. It is safe to be shipped by air as common goods.
Grade: Pharmaceutical Grade
Purity or Assay: 99.0%~101.0 (By HPLC)
Standards: EP/BP
Manufacturer Documents Available: COA/MSDS/SDS
Supply Capability: Over 100 KG per month
MOQ: 10 KG
Lead Time: 3~4 days for quantities less than 50 KG
Stock Status: Over 100 KG
Shipping Temperature: Room temperature
Storage: Room temperature
FAQs About Ambroxol APIs
What is Ambroxol Hydrochloride API used for in pharmaceutical manufacturing?
Ambroxol Hydrochloride API is the active ingredient in mucolytic formulations for acute and chronic respiratory tract disorders associated with viscid mucus, including acute bronchitis, exacerbations of chronic bronchitis, bronchial asthma, bronchiectasis, and COPD. It is also used off‑label in neonatal respiratory distress syndrome and, at high doses, for neuronopathic Gaucher disease and Parkinson’s disease (glucocerebrosidase enhancement). Finished dosage forms include oral solutions, syrups, tablets, effervescent tablets, sustained‑release capsules, and injectable ampoules.
What is the mechanism of action of Ambroxol?
Ambroxol exerts multiple pharmacological effects: it stimulates surfactant production in type II pneumocytes, activates ciliary beat frequency, reduces mucus viscosity by depolymerizing mucopolysaccharides, and exhibits local anesthetic and antioxidant properties. At high doses, it acts as a pharmacological chaperone for glucocerebrosidase (GCase), increasing its activity in lysosomes – the basis for its repurposing in Gaucher and Parkinson’s diseases.
Do you have an active US DMF and CEP for Ambroxol Hydrochloride?
Yes. Our US Type II DMF is active and available for reference. We also hold an issued EU CEP for the USP/Ph. Eur monograph. Both are ready to support your ANDA or MAA filing.
Is Ambroxol Hydrochloride API manufactured under cGMP?
Absolutely. Our facility is cGMP‑certified (EU‑GMP, WHO‑GMP). We do not supply non‑GMP material for human drug use. Every batch is produced under full GMP controls.
Can compounding pharmacies legally use Ambroxol Hydrochloride API?
Yes. Ambroxol is available in many countries as an over‑the‑counter or prescription drug. Compounding from bulk API is permitted under USP <795> when the commercial product is not suitable (e.g., preservative‑free, sugar‑free, custom strength, alternative vehicle). Pediatric oral suspensions (e.g., 3‑6 mg/mL) and high‑dose capsules (100‑300 mg) for neurological protocols are common compounded preparations. Our CoA includes microbial limits, heavy metals, and particle size – required for USP compliance.
What is the stability of Ambroxol Hydrochloride API and compounded suspensions?
Our API is stable for 36 months when stored in tightly sealed containers at controlled room temperature (15‑25°C), protected from light and moisture. For compounded oral suspensions (e.g., 6 mg/mL in Ora‑Plus or simple syrup), a beyond‑use date of 14‑30 days refrigerated (2‑8°C) is typical. For high‑dose capsules (anhydrous), BUD can be up to 6 months at room temperature if packaged in tight, light‑resistant containers. In‑house stability data is available upon request.
What is your MOQ and lead time for commercial orders?
The standard MOQ is 1 kg for R&D or clinical trial material and 25 kg for commercial supply. For bulk orders (100 kg+), lead time is 4‑6 days after order confirmation. We maintain safety stock for urgent requirements – please inquire.
Do you offer custom particle size or micronization?
Yes. Particle size affects dissolution rate, blend uniformity, and suspension properties. We offer standard crystalline grade (D90 < 150 μm) and micronized grade (D90 < 20 μm). Minimum custom batch is 5 kg.
What impurity profile should I expect for Ambroxol Hydrochloride API?
Our in‑house specification limits total related substances to ≤ 1.0%, with every single impurity ≤ 0.3%. Known impurities include bromohexine (the precursor), trans‑ambroxol (geometric isomer), and degradation products formed under acidic or oxidative conditions. A complete list of impurities, along with their retention times, is included in the DMF.
Is Ambroxol Hydrochloride still patent‑protected in major markets?
No. Ambroxol is off‑patent globally. The basic composition patents expired decades ago. Generic products are widely available. However, formulation patents for specific sustained‑release or high‑dose products may exist. Buyers must conduct their own freedom‑to‑operate analysis.
How do I get a sample for formulation development?
Request a sample via the contact form. We ship 100‑200 g samples within 5‑7 business days under a material transfer agreement. Samples are free for qualified pharmaceutical manufacturers and compounding pharmacies; you pay shipping.
What excipients are compatible with Ambroxol Hydrochloride API?
For oral solutions and syrups, compatible excipients include sorbitol, glycerin, propylene glycol, sodium benzoate, methylparaben, propylparaben, citric acid, and fruit flavorings. For tablets and capsules, standard excipients include microcrystalline cellulose, lactose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. Excipient compatibility data is available upon request.
Do you support veterinary applications?
Yes. Ambroxol is used in veterinary medicine for respiratory conditions in dogs, cats, horses, and birds. Our API can be supplied with veterinary‑specific documentation. Please inquire.
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