Doxycycline Hyclate Powder

Doxycycline Hyclate Powder for Pharmaceutical Applications | High-Purity Antibiotic Raw Material with cGMP Certification

Shaanxi Hongda Phytochemistry Co., Ltd. is a trustworthy manufacturer and supplier of Doxycycline Hyclate Powder of pharmaceutical quality raw material antibiotics to pharmaceutical manufacturers and research centers worldwide. Over 20 years of manufacturing experience at CHANGYI since 2001. Our 20,000-square-meter plant has 100,000-level purification workshops and over 10 modern manufacturing lines, producing 3,000 tonnes annually. Thru conventional extraction and purification procedures, we meet cGMP, ISO22000, and FSSC22000 pharmaceutical standards with 99% purity. For faster formulation development and market entry, partner with Hongda for solid supply chains, third-party verified quality, and full technical support.

Product Description

Pharmaceutical grade tetracycline antibiotic derivative created utilising controlled synthesis methods. The light yellow crystalline powder is soluble and thermally stable, making it appropriate for many pharmaceutical formulations. CAS: 564-25-0 Purity: 99% This drug meets stringent international pharmacopoeia requirements and is 99% pure. Our cutting-edge purification process eliminates impurities and residual solvents for pharmaceutical batch-to-batch homogeneity. Pre-release quality control includes HPLC analysis, heavy metal screening, and microbiological testing.

Doxycycline Hyclate Powder Advantages

Improved Stability Profile: The hyclate salt form shows better stability than monohydrate forms, minimising the danger of deterioration during storage and transit. That means longer shelf life and less material loss in your manufacturing processes.

Enhanced Bioavailability: Formulation clinical trials demonstrate increased dissolution and absorption kinetics, resulting in better therapeutic efficacy of the final pharmaceutical formulations.

Low Moisture Sensitivity: Unlike hygroscopic materials, this substance retains its flowability and physical qualities across various humidity levels, making it easier to handle in production situations.

Regulatory Compliance: We provide comprehensive documentation packages including Drug Master Files (DMF) assistance to facilitate your regulatory submission procedures for FDA, EMA and other foreign jurisdictions.

Uses of Doxycycline Hyclate Powder

Oral formulation development: This is the major Active Pharmaceutical Ingredient in tablet, capsule and solution formulations for bacterial infection. It is also compatible with popular excipients, therefore allowing easier formulation creation.

Veterinary Medicine Production: Widely used in veterinary pharmaceutical formulations for the treatment of livestock and companion animal illnesses, fulfilling stringent feed additive quality criteria.

Research and Development: Academic and commercial research facilities use high purity material to study antibiotic resistance, create new delivery systems and do pharmacokinetic studies.

Manufacturing Services: Third-party pharmaceutical manufacturers use this raw material for client-based formulation projects and benefit from our constant quality and extensive documentation assistance.

Manufacturing Process

Step 1 - Raw Material Procurement and Verification Qualified pharmaceutical intermediates are received and are subject to incoming quality assessment by HPLC and spectroscopic analysis. The starting material is verified as meeting internal criteria before beginning manufacturing.

Step 2 - Controlled Synthesis Reaction: The chemical reaction takes place in temperature controlled reactors under a nitrogen environment, forming the hyclate salt complex with little impurity creation.

Step 3 – Purification and crystallisation: Several recrystallisation procedures using pharmaceutical-grade solvents provide process-related impurities free high-purity crystals that fulfil the criteria of the pharmacopoeia.

Step 4 - Drying and Micronization: A controlled temperature vacuum drying removes moisture and precision milling creates the right particle size distribution for pharmaceutical manufacturing.

Step 5 - Quality Testing and Release Full analytical testing (assay, impurity profile, microbiological testing) is done and meets specifications before release for packing in double layer PE bags in fibre drums.

Third Party Test Report

Verification by independent laboratory: Our product is fully third party tested by the SGS and Eurofins labs for impartial verification of product parameters. These globally recognised testing laboratories test for pesticide residues, heavy metal content and microbiological parameters as per USP and EP requirements.

Stability Testing: Long term stability tests show that material kept correctly retains more than 98% potency for 24 months when maintained under regulated temperature settings, providing you with flexibility in inventory management.

Residual Solvent Analysis: Gas chromatography testing guarantees that residual solvent levels stay well within ICH Q3C requirements, protecting your formulation integrity.

Why choose us?

Leveraging the production scale and scientific competence, Shaanxi Hongda has more than 150 competent technicians and 20+ professor-level researchers. The SGS-certified laboratory is equipped with HPLC, GC and atomic absorption spectrophotometers to provide quality control. The warehouse of 3,000 square meters, with dedicated storage areas, enables the segregation and traceability of materials. We are committed to worldwide quality standards, shown by our Certifications like HALAL, KOSHER, cGMP and ISO9001. We are a national high-tech firm and keep investing in process innovation and capacity growth. You get on-time delivery supported by deep inventory, technical assistance from skilled application experts and affordable pricing that reflects our efficient economics of manufacturing.

OEM/ODM Support

Custom Formulation Services Our R&D team interacts directly with your scientists to produce customised Doxycycline Hyclate Powder formulations for particular therapeutic purposes or delivery methods.

Private Labelling Solutions: We provide whole package customisation with branded fibre drums, bespoke labels and paperwork to meet your business needs.

Technical Documentation Support: We can generate complete CoA, stability data and regulatory support documents to meet the needs of your target market, helping to reduce your compliance strain.

Scalable Production Volumes: Whether you need pilot size batches for clinical trials or multi-ton commercial production runs, we’re with you every step of the way from development thru to market launch.

FAQ

Q: What is the minimum order quantity for initial purchases?

A: We accommodate orders starting from 25kg (one drum) for evaluation purposes, with flexible scaling for production requirements.

Q: How do you ensure consistent quality across different production batches?

A: Every batch undergoes identical analytical testing protocols with strict acceptance criteria. Retain samples enable retrospective analysis if needed.

Q: What documentation do you provide for regulatory submissions?

A: Standard packages include CoA, manufacturing flow diagram, stability data, and regulatory compliance statements. DMF support available upon request.

Q: What is your typical lead time from order to delivery?

A: Stock availability enables 3-7 working days delivery. Custom specifications may require 15-20 days depending on production scheduling.

Q: Do you offer samples for formulation development work?

A: Yes, we provide 20-100g samples in aluminum foil Packaging with complete analytical documentation for your evaluation.

Contact Us

Ready to secure a reliable supply of pharmaceutical-grade Doxycycline Hyclate Powder for your manufacturing operations? Contact Us today at duke@hongdaherb.com  to request samples, obtain quotations, or schedule a virtual facility tour.