OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

Ambroxol HCl

Name: Ambroxol HCl
Brand: OREX PHARMA PVT. LTD

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MOQ : 100 Kilograms

Ambroxol HCl Specification

Molecular Formula
C13H18Br2N2OHCl

Ph Level
4.5 - 6.0 (1% solution)

Melting Point
233-237C

Structural Formula
See image

Poisonous
Non-poisonous at therapeutic doses

Solubility
Freely soluble in water, soluble in methanol, practically insoluble in acetone, ethanol

Molecular Weight
414.56 g/mol

Shelf Life
3 years

Particle Size
Typically < 10 micron

Color
White

Heavy Metal (%)
< 0.001%

Boiling point
Not available (decomposes before boiling)

Loss on Drying
< 0.5%

EINECS No
245-842-9

Storage
Store in a cool, dry place, protected from light

HS Code
29224990

Smell
Odorless

Taste
Bitter

Medicine Name
Ambroxol HCl

Chemical Name
Trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride

CAS No
23828-92-4

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Expectorant, mucolytic therapy in respiratory tract diseases

Purity(%)
>99%

Appearance
White to almost white crystalline powder

Physical Form
Solid

Packing
HDPE drum with double polyethylene bags, 25kg net

Identification
Conforms to standard (IR and HPLC methods)

Related Substances
< 0.1% (by HPLC)

Residual Solvents
Complies with ICH Q3C guideline

Chloride Content
12.8% - 13.2%

Microbial Limits
Total aerobic microbial count: < 1000 CFU/g; Total yeast & molds: < 100 CFU/g

Specific Optical Rotation
+98 to +102 (c=1, water)

Manufacturing Method
Synthetic process according to GMP

Ambroxol HCl Trade Information

Minimum Order Quantity
100 Kilograms

Payment Terms
Cash in Advance (CID)

Supply Ability
5000 Kilograms Per Month

Delivery Time
10 Days

Main Export Market(s)
Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa

Main Domestic Market
All India

About Ambroxol HCl

Ambroxol HCl is a mucolytic agent that dissolve the thick muccus that get collected inside the lungs and wind pipes thus give relief from respiratory problems. Our vendors professional utilize premium quality ingredients in formulation of this product. Moreover, we are offering this Ambroxol HCl to our most valued patrons at leading market rates.

High Purity, Consistent Quality

Ambroxol HCl is rigorously tested, with purity levels surpassing 99% and related substances kept below 0.1%. It conforms to international identification and residual solvent standards, guaranteeing safety and consistency for pharmaceutical formulations. Every batch is manufactured under GMP conditions, ensuring reliability and trust for suppliers and manufacturers.

Optimal Physical Properties for Formulation

This API presents as a white crystalline powder with a fine particle size typically below 10 microns, facilitating easy mixing and processing in various dosage forms. Its specific optical rotation, pH profile, and solubility make it adaptable for different pharmaceutical applications, increasing its versatility in treating respiratory conditions.

Safe and Reliable Active Ingredient

Ambroxol HCl is non-poisonous at therapeutic doses and complies with strict microbial and heavy metal limits. The product is packed securely in HDPE drums with double polyethylene bags and features a 3-year shelf life, granting peace of mind for storage and export needs. Its stability and safety profile make it a top choice for mucolytic therapy in respiratory care.

FAQ's of Ambroxol HCl:

Q: How is Ambroxol HCl manufactured and packed to ensure quality and safety?

A: Ambroxol HCl is synthesized using a controlled, GMP-compliant synthetic process. It is securely packed in 25kg HDPE drums with double polyethylene bags to safeguard against moisture and contamination during storage and transportation.

Q: What is the primary usage of Ambroxol HCl in medicine?

A: Ambroxol HCl is mainly used as an expectorant and mucolytic agent for the treatment of diseases involving abnormal mucus production, such as chronic bronchitis, asthma, and other respiratory tract disorders.

Q: When is Ambroxol HCl preferred in pharmaceutical formulations?

A: This API is chosen when formulating medicines that require high purity, consistent particle size, and excellent solubility-qualities essential for effective respiratory therapies. Its compatibility with water and methanol makes it suitable for diverse dosages like syrups and tablets.

Q: Where should Ambroxol HCl be stored for maximum stability?

A: Ambroxol HCl should be stored in a cool, dry place protected from light, ensuring the temperature remains stable to maintain its integrity and extend its 3-year shelf life.

Q: What are the benefits of using Ambroxol HCl as an API in respiratory therapeutics?

A: Using Ambroxol HCl offers reliable mucolytic action, supporting easier expectoration and improving patient respiratory health. It has a well-established safety profile and meets stringent quality criteria, making it ideal for pharmaceutical development.

Q: How does the product comply with global pharmaceutical standards?

A: Ambroxol HCl meets pharmaceutical grade requirements, with conformity to IR and HPLC identification, strict limits on related substances and residual solvents, and compliance with ICH Q3C and microbial safety guidelines, ensuring global export readiness.

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