Mesalamine API

Name: Mesalamine API
Brand: Shreeneel Chemicals
Price: 2500 INR
Availability: InStock

2500 INR/Kilograms

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Product Details:

Heavy Metal (%) Not more than 0.001%
Solubility Slightly soluble in water, freely soluble in alkaline solutions
Particle Size 90% < 150 m
Molecular Weight 153.14 g/mol
Taste Bitter
Molecular Formula C7H7NO3
Color Off-white to light brown
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Mesalamine API Price And Quantity

Minimum Order Quantity 100 Kilograms
Price 2500 INR/Kilograms

Mesalamine API Product Specifications

Ph Level 4.0 6.0 (1% solution)
EINECS No 201-924-7
Appearance Off-white to tan crystalline powder
Poisonous Non-poisonous in prescribed doses
CAS No 89-57-6
Chemical Name 5-Amino-2-hydroxybenzoic acid
Shelf Life 5 years
Storage Store in a cool, dry place tightly closed
Medicine Name Mesalamine API
Usage Used in treatment of Ulcerative Colitis and Crohns Disease
Boiling point Not applicable (decomposes)
Grade Pharmaceutical Grade
Structural Formula C7H7NO3
Physical Form Powder
HS Code 29222990
Type Active Pharmaceutical Ingredient
Smell Odorless
Color Off-white to light brown
Loss on Drying Not more than 0.5%
Melting Point 285287C
Solubility Slightly soluble in water, freely soluble in alkaline solutions
Heavy Metal (%) Not more than 0.001%
Molecular Formula C7H7NO3
Molecular Weight 153.14 g/mol
Taste Bitter
Particle Size 90% < 150 m
Purity(%) 99.5%

Mesalamine API Trade Information

Supply Ability 1000 Kilograms Per Week
Delivery Time 15 Days
Main Export Market(s) Asia
Main Domestic Market All India

Product Description

Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease. It belongs to the class of drugs known as aminosalicylates, and it works locally in the gastrointestinal tract to reduce inflammation and alleviate symptoms associated with IBD.

Pharmacopoeial Quality Standards

Mesalamine API meets stringent pharmacopoeial standards, including USP, EP, and BP guidelines. The API is verified through IR and HPLC identification tests. Impurity levels, residue on ignition, moisture content, and heavy metals are all rigorously controlled, ensuring consistent potency and purity. Stability data and comprehensive documentation are also available upon request.

Safe Storage & Packaging

Proper packaging and storage are essential for maintaining Mesalamine API quality. It is supplied in 25 kg HDPE drums lined with double polyethylene bags to preserve integrity and protect against contamination. The product should be stored tightly closed, in a cool, dry location to maintain its efficacy and extend shelf life up to five years.

Therapeutic Application & Benefits

Mesalamine API is widely used for manufacturing medicines for ulcerative colitis and Crohn's disease. Its high purity and verified safety profile-being non-poisonous at prescribed doses-ensure suitability for pharmaceutical formulations. The off-white to tan powder is well characterized and easy to process, supporting consistent drug manufacturing.

FAQ's of Mesalamine API:

Q: How is Mesalamine API identified according to pharmacopoeial standards?

A: Mesalamine API is identified using Infrared Spectroscopy (IR) and High-Performance Liquid Chromatography (HPLC) as per USP, EP, and BP guidelines. These methods confirm both its chemical structure and purity.

Q: What quality control measures are applied to related substances in Mesalamine API?

A: The total impurities in Mesalamine API are monitored to ensure they do not exceed 0.5%. These are quantified using pharmacopoeial methods during batch release and stability testing.

Q: When should Mesalamine API be used in pharmaceutical manufacturing?

A: Mesalamine API should be utilized when producing drugs for ulcerative colitis or Crohn's disease that require a high-purity, pharmaceutical-grade active ingredient compliant with major pharmacopeias.

Q: Where is Mesalamine API manufactured and how is it packaged?

A: It is produced in India by established manufacturers and suppliers. Packaging is done in HDPE drums with double polyethylene liners, each containing a net weight of 25 kg to ensure safety during transit and storage.

Q: What is the manufacturing process and shelf life of Mesalamine API?

A: Mesalamine API is synthesized using a non-sterile, synthetic chemical process. When stored correctly, tightly sealed in a cool, dry place, it maintains stability and efficacy for up to five years.

Q: How should Mesalamine API be stored to maintain its quality?

A: Store the API in tightly closed containers in a cool, dry environment. Avoid exposure to moisture and direct light to preserve its physical properties and stability throughout its five-year shelf life.

Q: What are the benefits of using Mesalamine API in medicinal products?

A: The API offers pharmaceutical-grade purity (99.5%), rigorous quality controls, non-mutagenic and non-carcinogenic safety, and compliance with major pharmacopeias. These attributes ensure it supports safe and effective therapies for inflammatory bowel diseases.

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