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Ambroxol Hydrochloride (Ambroxol Hcl) Powder | EP6 Standard

» Pharmaceutical » Respiratory System APIs » Ambroxol Hydrochloride (Ambroxol Hcl) Powder | EP6 Standard

  • Specifications

Buy China EP6 Standard Ambroxol Hydrochloride (Ambroxol Hcl) Powder

 

What is Ambroxol hydrochloride?

Ambroxol hydrochloride is a medication indicated to alleviate chest congestion associated with conditions that include bronchitis, pneumonia and bronchospasm asthma. This medication is part of a class of drugs called mucolytics and works by thinning chest mucus in affected patients.

 

Ambroxol hydrochloride Basic Information

Product name Ambroxol Hydrochloride
CAS NO. 23828-92-4
Synonyms Ambroxol Hydrochloride
Category Pharmaceutical Raw Materials,Active Pharmaceutical Ingredients,Bulk Drugs,Fine Chemicals.
Purity 99% Ambroxol Hydrochloride
Appearance Ambroxol Hydrochloride powder
Shelf life 2 years
Usage Ambroxol Hydrochloride is a secretolytic agent used in the treatment of respiratory diseases associated with viscid or excessive mucus.
Storage Ambroxol Hydrochloride should be stored in a well-closed container at low temperature, keep away from moisture, heat and light.
Note Ambroxol Hydrochloride for R&D use only.

 

Ambroxol hydrochloride Certificate of Anlysis

Product name Ambroxol hydrochloride
CAS No. 23828-92-4 Outer Packing 25KG
Production date 14th Jan 2018 Shelf life 13th Jan 2020
Standard adopted EP6
Items of analysis Specification Results
Desciption White or yellowish Crystalline powder White crystalline powder
Identification Conform With EP6.0 Tests(A)(B)(C)(D) Conform
Appearance of solution Not more intensely colored than the reference solution Y6 Conform
Identificatione,IR Spectrum,Chlorides test Ratio 3.2to3.4 Conform
PH 4.5-6.0 5.6
Single impurity ≤0.1% 0.02%
Total impurity ≤0.3% 0.04%
Loss on drying ≤0.5% 0.19%
Sulphated ash ≤0.1% 0.06%
Heavy Metals ≤20PPM <20PPM
Assay 99.0%~101.0% 99.7%
Conclusion Qualified

 

Ambroxol hydrochloride Medical Uses

All forms of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, bronchitis with bronchospasm asthma. During acute exacerbations of bronchitis it should be given with the appropriate antibiotic.

 

Ambroxol hydrochloride side effects

Following oral administration of ambroxol hydrochloride tablets or syrup, certain patients can develop stomach upset side effects. These side effects can include nausea or indigestion, warn health officials at the Health Sciences Authority, a division of the Singapore Government. Stomach upset symptoms can become uncomfortable and may contribute to a decreased appetite in certain patients. To limit the development of these side effects, ambroxol hydrochloride should be taken with food. Patients who experience severe nausea or vomiting while taking this medication should contact a doctor.

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