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Mesalamine api powder

Name: Mesalamine api powder
Brand: NR LIFE CARE
Price: 1950 INR
Availability: InStock

Price 1950 INR/ Kilograms

Get a Price/Quote

MOQ : 25 Kilograms

Mesalamine api powder Specification

Structural Formula
C6H3(NH2)(OH)COOH

Ph Level
4.0 - 6.0 (in 1% solution)

Smell
Odorless

Melting Point
285C

Taste
Slightly bitter

Solubility
Slightly soluble in water, soluble in dilute alkali

Molecular Formula
C7H7NO3

Loss on Drying
0.5%

Heavy Metal (%)
0.002%

Particle Size
D90 < 150 m

Shelf Life
3 years

HS Code
29420090

Poisonous
Non-poisonous under normal conditions

Color
White to off-white

Molecular Weight
153.14 g/mol

EINECS No
201-918-1

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

Boiling point
Not applicable (decomposes)

Medicine Name
Mesalamine API Powder

Chemical Name
5-Aminosalicylic Acid

CAS No
89-57-6

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used for the treatment of ulcerative colitis and Crohns disease

Purity(%)
99.0%

Appearance
White to off-white crystalline powder

Physical Form
Solid

Allergen Information
Free from allergens

Stability
Stable under recommended storage conditions

Manufacturing Compliance
GMP Certified

Packing
HDPE drums with double polyethylene bags, 25 kg net

Impurity Profile
Complies with pharmacopeial standards (EP/USP/IP)

Residual Solvents
As per ICH guidelines

Bulk Density
0.45 to 0.55 g/cm

Microbial Limits
Complies with pharmacopeial requirements

Identification Methods
IR, HPLC, UV-VIS

Mesalamine api powder Trade Information

Minimum Order Quantity
25 Kilograms

FOB Port
NHAVA SHEVA

Payment Terms
Cash Advance (CA), Cash in Advance (CID)

Supply Ability
1000 Kilograms Per Day

Delivery Time
4 Days

Sample Policy
If order is confirmed we will reimburse the sample cost

Packaging Details
DRUM

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

Main Domestic Market
All India

Certifications
ALL

About Mesalamine api powder

Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis. Clinicians may use mesalamine off-labeled in Crohn disease after surgical resection of the affected bowel.

Comprehensive Impurity Profile

Mesalamine API Powder meets all relevant impurity standards set by the European, United States, and Indian Pharmacopeias. Advanced techniques such as IR, HPLC, and UV-VIS are used for identification, ensuring purity and safety. Heavy metals and residual solvents comply fully with ICH and pharmacopeial guidelines, giving manufacturers confidence in product quality and patient safety.

Excellence in Manufacturing and Safety

Manufactured in GMP-certified facilities, this API upholds superior safety and consistency standards. The product is non-poisonous under normal conditions, allergen-free, and subjected to rigorous microbial testing. Each batch is packed in high-grade HDPE drums with double polyethylene lining for optimal protection against moisture, contamination, and degradation.

Clinical Effectiveness and Application

Mesalamine APIs provide substantial benefits in the management of ulcerative colitis and Crohn's disease. With 99.0% purity and pharmaceutical-grade quality, the API is formulated for excellent tolerability. Its stability allows for secure, long-term storage (up to three years), supporting both bulk pharmaceutical processing and tailored medical formulations.

FAQ's of Mesalamine api powder:

Q: How is the impurity profile of Mesalamine API Powder controlled?

A: The impurity profile of Mesalamine API Powder complies strictly with pharmacopeial standards, including EP, USP, and IP. Comprehensive analytical methods such as IR, HPLC, and UV-VIS are employed to ensure all impurities and residual solvents are within acceptable limits, adhering to ICH guidelines for patient safety.

Q: What is the recommended process for storing Mesalamine API Powder to maintain its stability?

A: To preserve its stability, Mesalamine API Powder should be stored in a tightly sealed container in a cool, dry environment, protected from direct light. This method maintains its efficacy and purity for its full three-year shelf life.

Q: When should Mesalamine API Powder be used in pharmaceutical preparations?

A: Mesalamine API Powder is utilized during the formulation of medications for the treatment and management of ulcerative colitis and Crohn's disease. Its high purity and compliance with pharmacopeial standards make it ideal for therapeutic applications requiring stringent safety and efficacy.

Q: Where does Mesalamine API Powder originate, and how is it packaged for distribution?

A: Mesalamine API Powder is manufactured in India under GMP certification and is distributed globally. It is securely packed in 25 kg HDPE drums lined with double polyethylene bags to protect against contamination, moisture, and physical damage during transit and storage.

Q: What are the main benefits of using Mesalamine API Powder for pharmaceutical manufacturers?

A: Pharmaceutical manufacturers benefit from Mesalamine API Powder's 99.0% purity, consistent bulk density, and stringent microbial and chemical control. This reduces the risk of batch failure, ensures compliance with international regulations, and provides reliable support for high-quality pharmaceutical products.

Q: How does Mesalamine API Powder support patient safety and allergen-free formulations?

A: Mesalamine API Powder is allergen-free, non-poisonous under normal conditions, and complies with strict microbial and residual contaminant limits. These attributes make it suitable for safe, high-quality formulations, minimizing adverse reactions in sensitive patients.

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