OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

Salbutamol Sulphate IP

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Salbutamol Sulphate IP Specification

Storage
Store in a well-closed container and protected from light

Particle Size
As per specification / on request

Smell
Odourless

Ph Level
4.0 - 5.0 (1% solution)

Molecular Weight
287.37 g/mol

Shelf Life
5 years

Extraction Type
Synthetic

Solubility
Soluble in water

Taste
Slightly bitter

Melting Point
>200C (decomposes)

Heavy Metal (%)
0.001%

Structural Formula
(available on request)

Color
White to off-white

HS Code
29372200

Molecular Formula
C13H21NO3S

Loss on Drying
0.5%

Odour
Odourless

Poisonous
No (when used as directed)

EINECS No
256-953-0

Boiling point
Not applicable (decomposes)

Medicine Name
Salbutamol Sulphate IP/BP/EP

Chemical Name
Salbutamol Sulphate

CAS No
51022-70-9

Type
Pharmaceutical Raw Material

Grade
IP/BP/EP

Usage
Used for the treatment of asthma and chronic obstructive pulmonary disease (COPD)

Purity(%)
99% min

Appearance
White to off-white powder

Physical Form
Powder

Drug Mfg Lic No.
28-KD771

Gross Weight
72.989 KG

Storage Condition
Store in a well-closed container and protected from light.

Mfg Date
June 2020

Net Weight
25.000 KG

Batch No.
OREX/SAL/526/20220620

Exp Date
May 2021

Drum Number
01 of 01

Tare Weight
2.599 KG

About Salbutamol Sulphate IP

Salbutamol Sulphate BP/EP/IP/USP Pharmaceutical API | Orex Pharma Pvt Ltd

Product Description

Orex Pharma Pvt Ltd offers Salbutamol Sulphate for pharmaceutical companies seeking active pharmaceutical ingredients (APIs) for the development and manufacturing of respiratory medicines. Salbutamol Sulphate, also known as Albuterol Sulfate in the United States, is a short-acting beta-2 adrenergic agonist used in pharmaceutical formulations designed to help relax airway muscles and relieve bronchospasm.

Salbutamol Sulphate is an important pharmaceutical ingredient used in the production of suitable respiratory formulations for conditions such as asthma and other obstructive airway disorders. It is widely relevant to pharmaceutical formulation manufacturers, bulk drug procurement companies, contract manufacturing organisations, pharmaceutical distributors, and international sourcing partners.

Orex Pharma Pvt Ltd aims to support pharmaceutical businesses with a customer-focused approach, product-specific quality documentation, and professional assistance for domestic and international sourcing requirements.

Product Specifications

Product Name: Salbutamol Sulphate
Alternative Name: Albuterol Sulfate
Pharmacopoeial Standards: BP / EP / IP / USP, subject to the specific grade and applicable product specification
Product Category: Active Pharmaceutical Ingredient (API)
Therapeutic Category: Respiratory Medicine / Bronchodilator
Pharmacological Class: Short-Acting Beta-2 Adrenergic Agonist (SABA)
Primary Application: Manufacturing of respiratory pharmaceutical formulations
Target Industries: Pharmaceutical manufacturing, formulation development, and bulk drug procurement
Company: Orex Pharma Pvt Ltd

Applications of Salbutamol Sulphate

Salbutamol Sulphate is used as an active ingredient in suitable pharmaceutical formulations developed for the management of bronchospasm and other approved respiratory indications.

Potential formulation applications include:

Inhalation solutions and nebulisation preparations
Metered-dose inhaler formulations, where the appropriate API form and formulation requirements apply
Oral liquid preparations and syrups
Tablets and other approved dosage forms
Respiratory pharmaceutical product development and manufacturing

The suitability of Salbutamol Sulphate for a particular dosage form depends on the formulation design, applicable quality specifications, and regulatory approval in the destination market.

Why Choose Orex Pharma Pvt Ltd?

Orex Pharma Pvt Ltd welcomes enquiries from pharmaceutical companies seeking Salbutamol Sulphate for formulation development, commercial manufacturing, and pharmaceutical sourcing.

Our customer-oriented approach aims to support buyers with:

Enquiries for applicable pharmacopoeial grades
Product specifications and Certificate of Analysis (COA), where available
Safety Data Sheet (SDS) and relevant technical documentation
Bulk procurement and commercial quotation requests
Product availability and packaging information
International pharmaceutical sourcing and distribution enquiries

Global Pharmaceutical Supply Enquiries

Orex Pharma Pvt Ltd welcomes enquiries from pharmaceutical manufacturers, formulation developers, API distributors, importers, exporters, and procurement organisations worldwide.

For Salbutamol Sulphate BP/EP/IP/USP, contact Orex Pharma Pvt Ltd to enquire about the available grade, applicable specifications, quality documentation, packaging, minimum order quantity (MOQ), pricing, and international supply arrangements.

Orex Pharma Pvt Ltd Supporting Pharmaceutical Businesses with Quality-Focused API Sourcing and Professional Service.

Key Properties and Specifications

Salbutamol Sulphate IP is characterized by its high purity and stability, appearing as a white to off-white odorless powder. Its precise molecular composition (C13H21NO3S) and quality control-such as a low loss on drying (0.5%) and minimal heavy metal content (0.001%)-make it suitable for sensitive pharmaceutical applications. With a melting point above 200C and decomposition before boiling, this compound maintains its quality throughout varied formulation processes.

Uses and Applications in Medicine

Primarily, Salbutamol Sulphate IP serves as an active ingredient in medications for asthma and COPD, providing relief by relaxing the muscles in the airways and improving airflow to the lungs. Its high solubility and stringent manufacturing standards (IP/BP/EP) enable its utilization in both tablet and inhalation therapies, making it a versatile pharmaceutical raw material for global supply chains.

Safe Storage and Handling Guidance

To retain potency and integrity, Salbutamol Sulphate IP must be stored in a tightly sealed container, away from direct light. This ensures chemical stability over the recommended five-year shelf life. The material is non-poisonous when handled and used as directed, making it safe for pharmaceutical manufacturing environments with standard precautions.

FAQ's of Salbutamol Sulphate IP:

Q: How should Salbutamol Sulphate IP be stored for optimal shelf life?

A: It should be stored in a well-closed container and kept protected from light to ensure chemical stability and preserve its shelf life, which is up to five years under recommended conditions.

Q: What is the main medical benefit of using Salbutamol Sulphate IP?

A: The primary benefit is its ability to provide relief from asthma and chronic obstructive pulmonary disease (COPD) symptoms by relaxing airway muscles and improving airflow to the lungs.

Q: When is Salbutamol Sulphate IP typically used in pharmaceutical manufacturing?

A: This raw material is commonly used during the formulation of medications for asthma and COPD, particularly in the manufacture of tablets and inhalation solutions.

Q: Where can detailed technical information such as the structural formula or particle size be obtained?

A: Additional details like the structural formula and specific particle size can be provided upon request from the manufacturer or supplier, as they may vary based on application requirements.

Q: What processes are involved in the production of Salbutamol Sulphate IP?

A: It is produced synthetically following stringent pharmaceutical standards (IP/BP/EP), ensuring high purity (minimum 99%) and compliance with international regulatory guidelines.

Q: How is the product's safety ensured during handling and usage?

A: Salbutamol Sulphate IP is not considered poisonous when used as directed. Standard storage, handling precautions, and compliance with safety procedures minimize any potential risk during pharmaceutical processing.

Q: What are the physical characteristics and appearance of this raw material?

A: Salbutamol Sulphate IP appears as a white to off-white, odorless powder with a slightly bitter taste and is supplied in drums that are clearly labeled with batch and weight details for traceability.

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