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Ambroxol Hydrochloride API

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Ambroxol Hydrochloride API Specification

Melting Point
233-234 C

HS Code
2922199090

Shelf Life
3 years

EINECS No
245-941-3

Heavy Metal (%)
0.001%

Smell
Odorless

Color
White

Ph Level
5.0-6.5 (1% solution)

Storage
Store in a tightly closed container, in a cool, dry place, away from light

Molecular Weight
414.56 g/mol

Solubility
Soluble in water, alcohol, and slightly soluble in ether

Taste
Slightly bitter

Molecular Formula
C13H18Br2N2OHCl

Structural Formula
C13H18Br2N2OHCl

Poisonous
Non-poisonous as API; toxicity depends on dose

Loss on Drying
0.5%

Particle Size
10 micron

Medicine Name
Ambroxol Hydrochloride API

Chemical Name
(2-amino-3,5-dibromo-benzyl)amino]-cyclohexanol hydrochloride

CAS No
23828-92-4

Type
Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Used as an expectorant in respiratory diseases and cough syrups

Purity(%)
>=99%

Appearance
White or almost white crystalline powder

Physical Form
Solid

Residual Solvent
Meets ICH guidelines

pH of 1% Solution
5.0-6.5

Chloride Content
Complies with pharmacopeia requirement

Microbial Limit
Total aerobic microbial count NMT 100 cfu/g

Identification
Complies with standard tests (IR, HPLC)

Assay (on dried basis)
99.0% to 101.0%

USP/BP/EP Conformance
Complies

Packaging
Fibre drums with double polyethylene bags, 25 kg net

Related Substances
NMT 0.1%

Ambroxol Hydrochloride API Trade Information

Supply Ability
100 Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Ambroxol Hydrochloride API

Packaging Size	25kgs
Product Type	API
Shelf life	4yrs
Color	white
Purity	99.39 %
Minimum Order Quantity	25 Kg

Grade - IPi i i Make -i Paragon / shilpa, styrixi
READY STOCKi Indian make.
All documents will be providedii

Superior Quality and Compliance

Ambroxol Hydrochloride API stands out for its exceptional compliance with internationally recognized standards, including USP, BP, and EP. Each batch undergoes rigorous identification testing using IR and HPLC to guarantee authenticity and integrity. The strict control of related substances and residual solvents assures pharmaceutical manufacturers of a highly pure and reliable ingredient.

Efficient Expectorant Functionality

This API is specifically designed for incorporation into medicines for respiratory ailments. It acts as a potent expectorant, helping to clear sputum and ease breathing in patients suffering from cough and associated conditions. Its proven efficacy and stability make it a preferred choice for pharmaceutical formulations worldwide.

Safety, Handling, and Packaging

Ambroxol Hydrochloride API offers a favorable safety profile when handled according to pharmaceutical standards. It is non-poisonous in prescribed applications, odorless, and slightly bitter. Proper storage in tightly closed containers, protected from moisture and light, ensures stability. Packaging in fiber drums with double polyethylene bags maintains product integrity during global transport.

FAQ's of Ambroxol Hydrochloride API:

Q: How should Ambroxol Hydrochloride API be stored to maintain its shelf life?

A: Ambroxol Hydrochloride API should be stored in a tightly sealed container, placed in a cool, dry environment away from direct light. Following these conditions ensures a shelf life of up to three years while maintaining product stability and effectiveness.

Q: What are the primary uses and benefits of Ambroxol Hydrochloride API?

A: This API is primarily used as an expectorant in respiratory disease treatments and cough syrups. Its main benefit lies in its ability to break down and expel mucus, thereby facilitating easier breathing and improving patient comfort.

Q: How is the quality and purity of Ambroxol Hydrochloride API ensured?

A: Quality and purity are confirmed through compliance with EP, BP, and USP standards, IR and HPLC identification tests, and strict control of related substances (NMT 0.1%) and residual solvents (meets ICH guidelines). The product is also checked for microbial limits and heavy metals content.

Q: What is the process for identifying Ambroxol Hydrochloride API?

A: Identification is conducted by standard pharmacopeia tests such as Infrared Spectroscopy (IR) and High-Performance Liquid Chromatography (HPLC), which verify the chemical structure and purity of the ingredient.

Q: When should manufacturers consider using this API in their formulations?

A: Manufacturers should use Ambroxol Hydrochloride API during the development and production of medicines intended for respiratory health, particularly for expectorant and mucolytic applications in cough and cold preparations.

Q: Where can Ambroxol Hydrochloride API be obtained, and in what packaging options?

A: This API is available from leading exporters, importers, manufacturers, and suppliers in India, and is supplied in 25 kg fibre drums lined with double polyethylene bags to preserve quality during shipment and storage.

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