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Aceclofenac API

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Aceclofenac API Specification

Smell
Odorless

Molecular Formula
C16H13Cl2NO4

Ph Level
4.5 - 5.5 (1% solution)

Structural Formula
C16H13Cl2NO4

Taste
Bitter

Heavy Metal (%)
NMT 0.001%

Solubility
Slightly soluble in water, freely soluble in acetone, soluble in methanol

Color
White

Shelf Life
5 Years if properly stored

Melting Point
149-153C

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

Particle Size
90% Passing through 100 mesh

HS Code
29420090

EINECS No
620-525-7

Molecular Weight
354.19 g/mol

Poisonous
NO

Loss on Drying
NMT 0.5%

Medicine Name
Aceclofenac API

Chemical Name
2-[(2,6-dichlorophenyl)amino]phenylacetoxyacetic acid

CAS No
89796-99-6

Type
Pharmaceutical Active Ingredient

Grade
Pharma Grade

Usage
Analgesic, Anti-inflammatory

Purity(%)
99% Min

Appearance
White or Almost White Crystalline Powder

Physical Form
Solid

Identification (By IR)
Complies with standard

Microbial Limits
Meets USP specification

Bulk Density
0.45 0.65 g/cm

Chloride Content
Within pharmacopeial limits

Assay (on dried basis)
99.0% 101.0%

Related Substances
Total impurities NMT 0.5%

Residue on Ignition
NMT 0.1%

Moisture Content
NMT 0.5%

Aceclofenac API Trade Information

Supply Ability
1000 Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Aceclofenac API

Purity	99%
Packaging	25Kg Drum
CAS Number	89796-99-6
Chemical Formula	C16H13Cl2NO4
Molecular Weight	354.1847 g/mol
Melting Point	149-153 DegreeC
Boiling Point	486.0+-45.0 DegreeC
Manufacturer	NUTRA/ALKA/MAGMA

Specifications

CAS No:89796-99-6

Molecular Weight: 354.19

Specification: EP4/5/6

Package and Storage:

25kg/drum, 10kg/drum, inner package: two layers of PE bag,

outer package: fibre drum.

Stored in a cool, dry and ventilated place. Retest Period: 2 years.

Appearance: White or almost white crystalline powder.

Assay: 99.0-101.0%

TypeiAntibiotic and Antimicrobial Agents

Use:Anti-inflammatory; analgesic

Purity:99%

Quality:BP2002/BP2010

Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic properties used to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. It is reported to have a higher anti-inflammatory action or at least comparable effects than conventional NSAIDs in double-blind studiesi2,3,5. Aceclofenac potently inhibits the cyclo-oxygenase enzyme (COX) that is involved in the synthesis of prostaglandins, which are inflammatory mediators that cause pain, swelling, inflammation, and fever. Aceclofenac belongs to BCS Class II as it possesses poor aqueous solubilityi2. It displays high permeability to penetrate into synovial joints where in patients with osteoarthritis and related conditions, the loss of articular cartilage in the area causes joint pain, tenderness, stiffness, crepitus, and local inflammationi1. Aceclofenac is also reported to be effective in other painful conditions such as dental and gynaecological conditions.

Consistent Quality and Standards

Aceclofenac API is manufactured to meet stringent international quality standards, including assay values of 99.0-101.0% (on dried basis) and compliance with related substance limits (NMT 0.5%). The physical and chemical parameters such as melting point (149-153C), pH (4.5-5.5 in 1% solution), and residue on ignition (NMT 0.1%) ensure reliable consistency for pharmaceutical applications.

Applications and Benefits

Known for its potent analgesic and anti-inflammatory effects, Aceclofenac API is ideal for the formulation of pain relief and anti-inflammatory medications. Its white crystalline physical form and highly controlled purity make it suitable for use by pharmaceutical manufacturers worldwide. It is stable, versatile, non-poisonous, and features a long shelf life of up to 5 years under recommended storage conditions.

Controlled Manufacturing and Safe Handling

Produced, exported, and supplied by Indian manufacturers, Aceclofenac API is subject to thorough quality testing. Key indicators such as chloride content, heavy metals (NMT 0.001%), and microbial limits meet pharmacopoeial requirements. The powder's slight water solubility and good solubility in acetone and methanol aid in efficient formulation processes.

FAQ's of Aceclofenac API:

Q: How is the identity of Aceclofenac API confirmed?

A: The identity of Aceclofenac API is established using Infrared (IR) spectroscopy, which confirms that the product complies with pharmacopeial standards for its chemical structure.

Q: What are the key benefits of using Aceclofenac API in pharmaceutical formulations?

A: Aceclofenac API offers exceptional analgesic and anti-inflammatory properties, high purity (min 99%), and low impurity levels, making it a reliable choice for pain and inflammation management medications.

Q: When should Aceclofenac API be used in manufacturing processes?

A: Aceclofenac API should be incorporated during the active ingredient blending phase in pharmaceutical production, ensuring controlled dosage and efficacy in the final product.

Q: Where should Aceclofenac API be stored for optimal stability?

A: For maximum stability and shelf life, Aceclofenac API must be kept in a cool, dry place, protected from light, which also prevents degradation and ensures up to 5 years' shelf life.

Q: What processes ensure the purity and safety of Aceclofenac API?

A: The product undergoes rigorous quality control processes including testing for related substances, heavy metals, microbial limits, and moisture content, ensuring compliance with pharmacopeial and USP specifications.

Q: How is Aceclofenac API typically delivered by suppliers?

A: As a solid, white crystalline powder, Aceclofenac API is shipped in secure, moisture-protected containers, ready for formulation by importers, exporters, and manufacturers.

Q: What are the recommended usage guidelines for Aceclofenac API?

A: The API is intended solely for pharmaceutical use as an analgesic and anti-inflammatory agent. It should be handled by qualified personnel following regulatory guidelines for drug manufacture.

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