Name: Etoricoxib IP
Brand: OREX PHARMA PVT. LTD

08045815720

OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

Product Details:

Storage Store in a cool, dry place, protected from light and moisture
Particle Size D90 <10 microns (customized)
EINECS No Not listed
Color White to off-white
Heavy Metal (%) Not more than 0.001%
Smell Odorless
Taste Bitter
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Etoricoxib IP Price And Quantity

Minimum Order Quantity 100 Kilograms

Etoricoxib IP Product Specifications

CAS No 202409-33-4
Particle Size D90 <10 microns (customized)
Storage Store in a cool, dry place, protected from light and moisture
Usage Nonsteroidal Anti-inflammatory Drug (NSAID), used for the relief of inflammation and pain in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout
Medicine Name Etoricoxib IP
Physical Form Solid
Grade Pharmaceutical Grade
Molecular Formula C18H15ClN2O2S
Heavy Metal (%) Not more than 0.001%
Color White to off-white
Appearance White to off-white crystalline powder
EINECS No Not listed
Molecular Weight 358.84 g/mol
Taste Bitter
Smell Odorless
HS Code 29339900
Loss on Drying Not more than 0.5%
Structural Formula [See image above]
Purity(%) >=98%
Type Active Pharmaceutical Ingredient (API)
Melting Point 136-140C
Solubility Practically insoluble in water; soluble in methanol, ethanol, and DMSO
Shelf Life 36 months
Poisonous No (used as drug at therapeutic dose)
Chemical Name 5-Chloro-6-methyl-3-[4-(methylsulfonyl)phenyl]-2,3-bipyridine

Therapeutic Category Selective COX-2 inhibitor
LogP (Partition coefficient) 3.7
Chemical Class Diaryl substituted heterocycle
Manufacturing Process Complies with GMP and IP guidelines
Stability Stable under recommended storage conditions
Microbial Limits Within pharmacopeia requirements
USP Reference USP Monograph available
Residual Solvents Within ICH limits
Identification Meets IP standards (IR, HPLC, mass spectrometry)
Packaging HDPE drum or double PE bag with aluminum foil, customizable
pKa 4.6
Related Substances Not more than 0.5% (any impurity), total impurities NMT 1.0%
Assay (by HPLC) >=98.0% and <=102.0%
Polymorphism May exhibit polymorphism

Etoricoxib IP Trade Information

Payment Terms Cash in Advance (CID)
Supply Ability 5000 Kilograms Per Month
Delivery Time 10 Days
Main Domestic Market All India

Product Description

Etoricoxib IP results in the reduction of prostaglandin generation from arachidonic. It is used for the treatment of rheumatoid arthritis, psoriatic arthritis, gout, and chronic low back pain. Procured from the trusted vendor, the offered powder is processed using the latest processing techniques as per the set industry standard norms. Apart from this, Etoricoxib IP can be availed from us at market affordable price.

Pharmaceutical Excellence and Consistency

Etoricoxib IP is meticulously manufactured under GMP and IP guidelines, ensuring the highest standards of purity, safety, and consistency expected in pharmaceutical products. Its compliance with physical, chemical, and microbiological requirements guarantees that each batch adheres to international and pharmacopeial benchmarks, including assay (HPLC) and impurity profiles. This delivers dependable performance in final medicinal formulations.

Robust Stability and Shelf Life

Etoricoxib IP maintains its efficacy and physical integrity for up to 36 months when stored in cool, dry conditions, protected from light and moisture. Its excellent stability profile supports prolonged shelf life and reduces the risk of degradation. The customizable HDPE drum or double PE bag with aluminum foil packaging further safeguards the API against environmental factors during storage and transit.

Tailored Solutions for Pharmaceutical Manufacturing

As a versatile API, Etoricoxib IP is available with customized particle size distributions and flexible packaging options to support diverse manufacturing requirements. Suppliers and manufacturers receive detailed technical documentation, including USP monograph references and analysis reports, making regulatory submissions and formulation development seamless and efficient.

FAQ's of Etoricoxib IP:

Q: How is the quality and purity of Etoricoxib IP ensured during manufacturing?

A: Etoricoxib IP is manufactured in India following strict GMP and IP guidelines. Its identity is verified using IR, HPLC, and mass spectrometry. Impurity levels are controlled (not more than 0.5% for any impurity, total impurities NMT 1.0%), and the assay by HPLC ensures the product falls within 98.0-102.0% purity. Stringent quality control at every stage guarantees pharmaceutical-grade quality.

Q: What are the recommended storage and handling conditions for Etoricoxib IP?

A: To maintain optimal stability and potency, Etoricoxib IP should be stored in a cool, dry place, protected from light and moisture. The API is typically supplied in HDPE drums or double PE bags with aluminum foil, which help prevent contamination and degradation during storage and transit.

Q: When should Etoricoxib IP be used in pharmaceutical product development?

A: Etoricoxib IP is employed during the formulation stages of pharmaceuticals targeting the relief of inflammation and pain, particularly in conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and gout. Its reliable assay and impurity profile make it suitable for consistent results in medicinal products.

Q: Where does Etoricoxib IP find its principal application?

A: Etoricoxib IP is primarily used by pharmaceutical manufacturers and formulators developing nonsteroidal anti-inflammatory drugs (NSAIDs), especially selective COX-2 inhibitors. Its high quality and compliance make it a trusted API for international and domestic markets.

Q: Can the packaging or particle size of Etoricoxib IP be customized for different manufacturing needs?

A: Yes, Etoricoxib IP is available with customizable packaging-including HDPE drums and different barrier options-and particle size distributions (D90 <10 microns or as specified), to align with specific formulation and process requirements of manufacturers.

Q: What are the main benefits of using Etoricoxib IP as an API?

A: Etoricoxib IP offers consistent, high purity and meets stringent regulatory and pharmaceutical standards, providing manufacturers confidence in safety, efficacy, and compliance. Its robust stability and customizable options add further value for diverse pharmaceutical applications.

Q: What processes are employed during the regulatory and technical documentation of Etoricoxib IP?

A: Every batch of Etoricoxib IP is accompanied by comprehensive analytical documentation, including certificates of analysis, regulatory support data, and references to the USP monograph. This ensures smooth regulatory submissions and supports robust quality assurance for clients worldwide.

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OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

Pisal House, Stadium Road, Near CIDCO Bus StandThane - 400601, Maharashtra, India

Phone :08045815720

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