Gliquidone Powder

Gliquidone Powder - Premium Pharmaceutical Ingredient Manufacturer & Supplier

Shaanxi Hongda Phytochemistry is a prominent manufacturer and supplier of high purity Gliquidone Powder, and has supplied pharmaceutical firms and research institutions all over the world since 2001. We are a reputable supplier of this important antidiabetic chemical, and with over 20 years of manufacturing pharmaceutical grade raw materials, we utilise this experience to provide superior quality meeting worldwide pharmacopoeia standards. The 100,000-level purification workshop and SGS-standardized laboratory are advanced facilities to ensure that every batch of product is thoroughly tested for purity, potency, and safety. What sets us apart is our comprehensive quality control system from raw material sourcing to final product delivery, our capability to maintain consistent 99% purity specifications, and our Certifications including cGMP, FSSC22000, ISO9001, and ISO22000 which confirm pharmaceutical-grade reliability. Partnering with Hongda gives you access to secure supply chains, reasonable pricing through direct sourcing from factories, and the technical support of our team of over 20 professor-level R&D specialists who understand the rigorous demands of diabetes management formulations.

Product Introduction

Gliquidone bulk powder is a second generation sulfonylurea with a different metabolic pathway and a good safety profile in individuals with renal impairment. This white crystalline powder has superior purity with 99% specification and CAS number 33342-05-1, a suitable active pharmaceutical component for oral hypoglycemic formulations. In contrast to other sulfonylureas, over 95% of the product is excreted by the biliary route instead of the kidney, thus lowering the danger of buildup in diabetic patients with renal failure. Our pharmaceutical grade material has constant particle size distribution, low residual solvent levels, and negligible impurity profiles that meet USP/EP standard requirements. The chemical has molecular stability and dissolving profile appropriate for immediate release tablet formulations and modified release delivery systems for improved glycaemic management.

Third-Party Test Report

Purity Verification: Our product has been independently analysed by SGS laboratories and has been continuously shown to reach a purity of ≥99.0% by HPLC with UV detection at 254nm. The routine testing protocol confirms no relevant contaminants above 0.1% threshold values.

Heavy Metal Testing: Eurofins testing confirms meeting ICH Q3D criteria: Lead concentration < 1.0ppm, Arsenic < 0.5ppm, Mercury < 0.1ppm, Cadmium < 0.5ppm. Meets pharmaceutical safety standards for long term oral administration.

Microbial Quality: Total aerobic microbial count < 100 CFU/g Yeast and Mould counts < 10 CFU/g. All production batches were negative for the pathogenic pathogens E.coli, Salmonella and Staphylococcus aureus.

Residual Solvent Analysis: Ethanol residues 500ppm and acetone 500ppm are confirmed by gas chromatography (GC) testing, in compliance with Class 3 solvent limitations per ICH Q3C recommendations for pharmaceutical manufacture.

Certificate of Analysis (COA)

Please contact our professional team to get COA and more information:duke@hongdaherb.com.

Gliquidone Powder Advantages

Superior Bioavailability Profile: Our micronised product has better solubility rates than normal particle grades, achieving 85% dissolution in 30 minutes in a pH 6.8 phosphate buffer. This means speedier onset of hypoglycemic effect and more predictable pharmacokinetic characteristics in the tablet formulations.

Renal Safety Differentiation: With only 5% renal excretion (vs 95% biliary), this material is the sulfonylurea of choice in the elderly diabetic population and those with mild/moderate renal impairment, thus expanding your product’s addressable market without dose adjustment.

Manufacturing Process Compatibility: High flow characteristics (Carr's Index <15) and good compressibility allow you to manufacture direct compression tablets without the need for granulation processes. This saves you manufacturing costs and reduces production cycle times while preserving content uniformity.

Stability Advantage: Accelerated stability data demonstrates less than 2% degradation after 6 months storage at 40°C/75% RH, supporting 36-month shelf life claims in HDPE bottles with desiccant Packaging systems.

Gliquidone Powder Application

Oral Antidiabetic Formulations: The primary indication is for the treatment of type 2 diabetes mellitus using immediate-release tablets, commonly available in dosage strengths of 15-30mg. This substance is blended with common excipients such as microcrystalline cellulose, croscarmellose sodium and magnesium stearate to give quick disintegration profile.

Combination Therapy Products: Increasing use of fixed-dose combination tablets with metformin hydrochloride providing complementing mechanisms (increased insulin secretion and reduction of hepatic glucose production) that promote patient compliance through decreased pill load.

Clinical Research Applications: High purity pharmaceutical reference standards for bioequivalence studies, dissolution technique development, and analytical method validation that meet regulatory submission requirements for ANDA and NDA files.

Production Process

Step 1 - Raw Material Synthesis: The production process starts with the controlled chemical synthesis of pharmaceutical grade precursors in an inert atmosphere. This first step forms the sulfonylurea core structure and prevents oxidative degradation, providing high-purity intermediates with conversion yields of >98%.

Step 2 - Crystallisation Purification: The crude product is purified by multi-stage recrystallisation from solvent systems controlled by optimised temperature gradients. This purification approach removes process contaminants and isomeric variations in a systematic manner resulting in the pharmaceutical grade crystals with uniform shape and 99% + purity.

Step 3 - Micronization Processing: Purified crystals run through jet-milling equipment under cryogenic conditions to produce target particle size distribution (D90 <50μm). This micronization increases the surface area and dissolving rate, resulting in Gliquidone Powder with improved bioavailability qualities for rapid release formulations.

Step 4 - Quality Verification and Packaging: Final product undergoes comprehensive analytical testing including HPLC purity, residual solvent screening, heavy metal analysis, and microbial limits testing. The approved material is packed in pharmaceutical-grade double PE bags (12kg net weight) in fibre drums under controlled humidity conditions to guarantee stability throughout international transportation.

OEM / ODM Support

Custom Specification Development: Our R&D team interacts with your formulation scientists to generate tailored particle size distributions, polymorphic forms, or co-processed grades that maximise your unique tablet compression characteristics or capsule-filling requirements.

Regulatory paperwork Support: We can supply full Drug Master Files (DMF) paperwork, certificates of appropriateness (CEP) and full analytical testing packages to speed up your regulatory submissions to FDA, EMA and other global health authorities.

Small-Scale Trial Production: Before committing to commercial volumes, we offer pilot-batch manufacture (5-50kg amounts) enabling your stability studies, formulation development work, and clinical trial material production under cGMP-compliant circumstances.

Flexible Packaging Solutions: In addition to the usual 12kg drums, we are happy to satisfy customer special packaging requests, such as 1kg aluminium bottles for R&D volumes, 25kg fibre drums for high scale manufacturing or nitrogen flushed containers for prolonged stability requirements.

Why Choose Us?

You should work with Shaanxi Hongda because we combine pharmaceutical manufacturing prowess with fast customer service that understands your production timelines. Our facility is 20,000 square meters and has a continuous production capacity of more than 3,000 tonnes per year, so you never have to worry about supply interruptions that will stop your manufacturing lines. We have invested in cGMP, FSSC22000 and ISO certifications so your incoming material inspections are simplified, lowering your quality control burden and speeding up material release; Our scientific team is available to fix formulation issues, and we have 3,000 square meters of climate-controlled warehouse inventory, so we can supply in 3-7 days – rather than 4-6 weeks as is typically the case with international suppliers. When regulatory inspectors analyse your supply chain, our extensive documentation and traceability solutions provide the compliance confidence that protects your product registrations.

FAQ

Q: What is the minimum order quantity for the product?

A: Normally we need a minimum order quantity of 12kg (one drum) however for research and development we can accept lesser quantities. For commercial production we propose ordering in pallet quantities (27 drums/324kg) to maximise freight costs.

Q: Have you any formulation development samples?

A: Yes, we may provide free samples of 50-100g for eligible pharmaceutical companies for formulation research. Samples come with the COA and stability data to support your development work.

Q: How long does your product last on the shelf?

A: The product will be compliant to the standard for a period of 36 months from date of manufacture, provided it is stored in its original sealed packaging at a controlled room temperature of between 15 and 25 degrees Celsius and humidity < 60 percent relative humidity.

Q: Are you assisting with filings for Western markets?

A: Absolutely. We have complete technical files containing manufacturing process descriptions, impurity profiles, analytical methodologies and stability data packaged for DMF filings to help your FDA and EMA regulatory plans.

Q: What quality tests do you do before shipping?

A: Each production batch is subjected to a 12-point quality check prior to being released from the factory for export, including HPLC purity, moisture content, particle size, heavy metals, pesticide residues, microbiological limits and residual solvents, etc.

Contact Us

Ready to secure a reliable supply of pharmaceutical-grade Gliquidone Powder for your diabetes management formulations?Contact our team at duke@hongdaherb.com.