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Esomeprazole API

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Esomeprazole API Specification

Smell
Odorless

Solubility
Freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, practically insoluble in water

Heavy Metal (%)
0.001%

Molecular Weight
345.42 g/mol

Poisonous
Non-poisonous under recommended use

Loss on Drying
0.5%

Color
White to off-white

Particle Size
Not less than 90% passes through 60 mesh

Taste
Bland

Shelf Life
3 years from date of manufacture

Melting Point
155-157C

Molecular Formula
C17H19N3O3S

Structural Formula
See image reference

HS Code
29335990

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

Medicine Name
Esomeprazole

Chemical Name
(S)-5-Methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole

CAS No
119141-88-7

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used in the treatment of gastroesophageal reflux disease (GERD), peptic ulcer, and Zollinger-Ellison syndrome

Purity(%)
>= 99%

Appearance
White to off-white powder

Physical Form
Powder

Related Substances
Total impurities NMT 1.0%

Residual Solvents
Complies with USP/EP standards

Identification
IR, UV, HPLC as per pharmacopoeia

Microbial Limits
Total viable count NMT 1000 cfu/g, Yeast & Mold NMT 100 cfu/g

Water Content (Karl Fischer)
NMT 0.5%

Impurity Profile
Complies with ICH guidelines

Packaging
Double-layer polythene bags in fiber drums of 25 kg net each

Specific Rotation
+7.5 to +9.0

Assay (on anhydrous basis)
98.0% - 102.0%

Esomeprazole API Trade Information

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

Esomeprazole API About

Experience the grand value and extraordinary quality of Esomeprazole API, a sensational active pharmaceutical ingredient offered by a leading exporter, manufacturer, and supplier in India. Grab yours nowour pharmaceutical-grade Esomeprazole boasts a purity of over 99%, an impurity profile in line with ICH guidelines, and complies with USP/EP standards. Presented as a white to off-white powder, packaged in double-layer polythene bags within robust fiber drums (25 kg net), and certified for a shelf life of three years, it guarantees optimal safety, stability, and efficacy for GERD, peptic ulcer, and Zollinger-Ellison syndrome treatments. Get it now to secure the best value in excellence!

Extraordinary Competitive Advantages of Esomeprazole API

Esomeprazole API sets an exemplary benchmark with its grand purity level (99%), compliance with international standards, and unmatched quality control. Manufactured under strict guidelines, it features low microbial and heavy metal content, reliable assay values, and superb packaging that preserves integrity. Our sensational product is odorless, non-poisonous, and easily traceable via advanced testing methodsassuring safety and consistency. Customer-focused service, robust export logistics, and years of formulation expertise strengthen our competitive edge.

Quick Dispatch & Certifications for Global Markets

With Stock Ready for rapid fulfillment, we guarantee Quick Dispatch and transparent rate policies. Esomeprazole API is thoroughly certified, meeting USP/EP, ICH, and GMP standards, ensuring trustworthy quality for global buyers. Our main export markets include the US, Europe, and Asia, supported by efficient logistics. Flexible payment terms and smooth documentation create a hassle-free experience, empowering you to buy confidently from a reliable exporter with both value and speed in delivery.

FAQs of Esomeprazole API:

Q: How is Esomeprazole API packaged for shipment?

A: Esomeprazole API is securely packed in double-layer polythene bags and placed inside fiber drums, each containing 25 kg net, to ensure protection during transit.

Q: What certifications does Esomeprazole API comply with?

A: This API complies with pharmaceutical standards such as USP, EP, and ICH guidelines. It is also manufactured following GMP protocols for maximum quality assurance.

Q: What is the primary benefit of using Esomeprazole API?

A: Esomeprazole API is highly effective in treating GERD, peptic ulcer disease, and Zollinger-Ellison syndrome, delivering sensational therapeutic results and stellar value.

Q: Where is Esomeprazole API exported from?

A: Esomeprazole API is manufactured and exported from India, with robust supply capabilities serving the US, Europe, and Asia.

Q: What is the recommended storage process for Esomeprazole API?

A: Store Esomeprazole API in a cool, dry location away from light and moisture, in its original packaging, to ensure longevity and stability of the product.

Q: How is the impurity profile and residual solvents monitored for quality?

A: The impurity profile strictly adheres to ICH guidelines, while residual solvents meet USP/EP standards, verified through advanced testing (IR, UV, HPLC) during manufacturing.

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