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Gliclazide API

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Gliclazide API Specification

Poisonous
Non-poisonous under recommended usage

Structural Formula
C15H21N3O3S

Solubility
Freely soluble in dimethylformamide, sparingly soluble in methanol, practically insoluble in water

Loss on Drying
Not more than 0.5%

EINECS No
244-277-4

Melting Point
168-170C

HS Code
29420090

Particle Size
D90 <10 microns (customizable)

Taste
Bitter

Molecular Formula
C15H21N3O3S

Heavy Metal (%)
Not more than 0.001%

Color
White

Smell
Odorless

Shelf Life
36 months

Molecular Weight
323.41 g/mol

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

Medicine Name
Gliclazide API

Chemical Name
Gliclazide

CAS No
21187-98-4

Type
Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Used as an oral hypoglycemic agent in the treatment of type 2 diabetes mellitus

Purity(%)
99%

Appearance
White to off-white crystalline powder

Physical Form
Solid

Identification
Complies with standard USP/EP identification tests

Packaging
Double polyethylene bags with HDPE drum

Regulatory Compliance
US FDA, EDQM, WHO-GMP

Residue on Ignition
Not more than 0.1%

Microbial Limit
Complies with pharmacopeial standards

Manufacturing Process
Synthetic

Retest Period
36 months from date of manufacture

Other Names
Diamicron

Stability
Stable under normal conditions

Related Substances
Not more than 1.0%

Assay (by HPLC)
98.0% 101.0%

Polymorphic Form
Form I (standard)

Gliclazide API Trade Information

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

About Gliclazide API

Discover the matchless quality of our Gliclazide API, a meritorious choice for pharmaceutical manufacturers seeking unprecedented standards at the best price. With assured access to a pure, stable, and potent API (purity: 99%), this white to off-white crystalline powder complies with USP/EP identification tests and global regulatory requirements (US FDA, EDQM, WHO-GMP). Our product stands out for its high stability (36 months shelf life) and is delivered in robust double polyethylene bags within HDPE drums, safeguarding its ephemeral efficacy. Ideal for use in oral hypoglycemic agents, Gliclazide API ensures reliability in every batch. Experience superior quality, supported by comprehensive compliance documentation, unmatched throughout the market.

Exceptional Application Flexibility and Plant Integration

Gliclazide API is extensively used in pharmaceutical manufacturing plants for formulating oral hypoglycemic agents targeting type 2 diabetes mellitus. Its customizable particle size (D90 <10 microns) enhances plant adaptability, supporting various dosage forms. Features such as high assay purity, robust polymorphic stability (Form I), and negligible residue on ignition confirm its suitability for both large and small-scale production facilities, ensuring optimal effectiveness wherever applied within global pharma plants.

Certified Exports, Strategic Markets, and Protective Packaging

Our Gliclazide API is US FDA, EDQM, and WHO-GMP certified, making it eligible for both domestic and international markets. With established freight channels, we serve the main domestic markets across India and export to numerous global destinations efficiently. The product is securely packaged in double-layered polyethylene bags within HDPE drums, minimizing damage during transit and shipment. Charges are transparently communicated, ensuring worry-free, compliant delivery from manufacturer to end-user worldwide.

FAQ's of Gliclazide API:

Q: How is the quality of Gliclazide API ensured during manufacturing and packaging?

A: The Gliclazide API undergoes rigorous quality checks with compliance to USP/EP identification tests, and is packaged in double polyethylene bags within HDPE drums to protect its stability and purity during transport and storage.

Q: What makes this Gliclazide API meritorious for pharmaceutical manufacturers?

A: Its matchless purity of 99%, stability under normal conditions, and comprehensive regulatory compliance (US FDA, EDQM, WHO-GMP) make this API especially suitable for formulators demanding high-quality active ingredients for their products.

Q: Where can Gliclazide API be applied within pharmaceutical production environments?

A: It is primarily used in the production of oral hypoglycemic agents in plants that manufacture medicines for type 2 diabetes mellitus, with versatile particle size options to integrate seamlessly into various drug formulations.

Q: When should the Gliclazide API be retested for quality assurance?

A: The retest period is up to 36 months from the date of manufacture, as long as the API is stored under recommended conditions (cool, dry place, protected from light).

Q: How does the freight and packaging process preserve product quality during export?

A: Carefully designed packaging-double-layered polyethylene bags inside HDPE drums-coupled with efficient freight logistics, ensures the product reaches both domestic and international clients intact, maintaining its quality through the supply chain.

Q: What benefits does the customizable particle size of Gliclazide API offer?

A: Customizable particle size (D90 <10 microns) allows formulators to tailor the API for optimal dissolution and bioavailability in specific dosage forms, maximizing therapeutic effectiveness and production efficiency.

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