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Progesterone Micronized Powder USP
2.Appearance: White powder
3.Specification: 99%
4.Main Market: Europe, America, Vietnam, Indonesia, Southeast Asia, Thailand, Russia, etc.
5.Packing Specification: 25kg/drum, 27 drums/tray
6.Delivery: 3-7working days
7.Certification: cGMP,FDA,FSSC,KOSHER,HALAL,BRC,ORGANIC,ISO9001,ISO22000 etc.
- Product Description
Progesterone Micronized Powder USP: Premium-Grade API for Pharmaceutical Excellence
Shaanxi Hongda supplies USP-grade Progesterone Micronized Powder USP, strictly adhering to the latest USP/EP/BP pharmacopoeia standards. We utilize cutting-edge "supersonic airflow pulverization" technology to ensure a stable D90 particle size below 10μm, providing you with a high-standard raw material characterized by "high utilization rate, low dose variability, and universal applicability across all dosage forms." This micronized progesterone meets stringent USP standards, guaranteeing bioequivalence (BE). By reducing particle size to the micron level, we significantly increase the specific surface area, resulting in a 30-50 times faster drug dissolution rate.
Progesterone powder ensures optimal efficacy for women's health products, hormone replacement therapy (HRT), and pregnancy treatment products. Due to its optimized particle size and superior performance, it is trusted by pharmaceutical companies worldwide and used in pharmaceuticals and cosmetics.
Key Features & Benefits
Advanced Micronization Technology
Our innovative micronization technology makes particles that are all the same size, between 10 and 50 micrometers. This level of control makes it much easier for the drug to break down and be taken in. No matter what you're making—skin creams, tablets, or capsules—you'll end up with superior solubility.
Pharmaceutical-Grade Purity
Every batch exceeds 99% purity with strictly controlled impurity profiles. We maintain residual solvent levels well below ICH Q3C guidelines. Your products will meet the most demanding quality requirements from regulatory agencies globally.
Excellent compatibility with oil phase/gel systems
Hongda's micronized particles have excellent wetting properties, enabling them to rapidly fuse with vegetable oils (such as sesame oil and peanut oil) or polymer gel matrices without precipitation or crystal bridging, ensuring the physical stability of the formulation throughout its shelf life.
Regulatory Compliance Excellence
The FDA, EMA, and WHO have all given our companies cGMP certifications. We provide entire paperwork packages that come with Drug Master Files, Certificates of Analysis, and reliable data. Your regulatory submissions become streamlined with our comprehensive support.
Product Specification
Items | Standard | Test Result |
Appearance | White crystalline powder | Conform |
Assay | 98.0%~103.0% | 99.1% |
Melting Point | 126~131℃ | 127.5~129.5℃ |
Loss On Drying | ≤0.5% | 0.19% |
Specific Rotation | +175°~+183° | +180° |
Total Impurity | ≤0.8% | 0.5% |
Water Content | ≤0.15% | 0.14% |
Lead(mg/kg) | ≤2.0 | Conform |
Arsenic(mg/kg) | ≤1.0 | Conform |
Cadmium(mg/kg) | ≤1.0 | Conform |
Mercury (mg/kg) | ≤0.1 | Conform |
Total Plate Count | ≤1000cfu/g | Conform |
Mold & Yeast | ≤100cfu/g | Conform |
E.Coli | Negative | Conform |
Salmonella | Negative | Conform |
Conclusion: Each Item meet with the USP42 standard . | ||
Progesterone Benefits
1. Preparing for implantation of the fertilized egg: In the late menstrual cycle, progesterone microencapsulated powder promotes glandular growth in the uterine mucosa, uterine congestion, and endometrial thickening, preparing the uterus for implantation. This reduces uterine excitability and ensures safe fetal growth.
2. Promoting Breast Development: Pure progesterone powder, when combined with estrogen, can promote rapid breast development and increase milk production.
3. Inhibiting Ovulation: Progesterone closes the cervix, reducing and thickening mucus, making it difficult for sperm to penetrate. It also inhibits the secretion of pituitary gonadotropins, resulting in an ovulation-inhibiting effect.
4. Diuretic: Progesterone antagonizes aldosterone, promoting the excretion of sodium and chloride ions and accelerating urination.
Applications in Women's HealthHormone Replacement Therapy
Your HRT formulations benefit from our consistent particle size distribution. The enhanced dissolution characteristics improve patient compliance and therapeutic outcomes.
Fertility Treatment Products
Fertility specialists trust our API for critical reproductive health applications. The reliable bioavailability supports consistent therapeutic levels in sensitive treatments.
Menopause Management Solutions
Develop effective menopause treatments using our stable, high-purity Progesterone Micronized Powder USP. Our API maintains potency throughout extended shelf-life periods.
Formulation Versatility
- Oral tablets and capsules
- Vaginal suppositories and creams
- Transdermal patches
- Sustained-release formulations
Quality & Manufacturing
Produced in GMP-certified facilities, our progesterone undergoes:
- HPLC/GC Testing: For potency and impurity profiling.
- Particle Size Analysis: Laser diffraction to ensure D90 <50µm.
- Stability Chambers: Accelerated ICH Q1A testing for shelf-life validation.
Quality & Manufacturing Excellence
State-of-the-Art Facilities
Our cGMP-certified manufacturers employ the most up-to-date tools to make sure that the quality of their goods never changes. We watch the environment closely and clean between runs using approaches that have been shown to work.
Stringent Quality Control
Every production step involves multiple quality checkpoints. Our analytical laboratories perform:
- High-Performance Liquid Chromatography (HPLC)
- Gas Chromatography for residual solvents
- Particle size distribution analysis
- Microbiological testing
- Heavy metals screening
Audit-Ready Documentation
We maintain comprehensive batch records and quality documentation. Your regulatory inspections become straightforward with our transparent record-keeping systems.
Why Choose Us?
1. 30+ Years of Expertise: Specialized in hormone API manufacturing.
2. End-to-End Support: Regulatory documentation, formulation troubleshooting, and custom packaging.
3. Transparent Partnerships: Audit-ready facilities with batch traceability.
“Hongda’s progesterone API enabled us to accelerate our HRT product launch with full FDA compliance.”
– Lead Formulator, European Pharma Manufacturer
FAQ
1. How does micronization improve progesterone performance?
Smaller particles increase surface area, enhancing dissolution rates and bioavailability in both oral and topical products.
2. Is your progesterone compliant with EP or JP standards?
Yes. We tailor certifications to meet EU Pharmacopeia (EP), Japanese Pharmacopeia (JP), and regional requirements.
3. Can you provide DMF or CEP documentation?
Absolutely. Our dedicated regulatory team supplies DMFs (US), CEPs (EU), and country-specific filings.
4. What packaging options are available?
Choose from double-layer polyethylene bags, aluminum cans, or custom vacuum-sealed containers to prevent moisture.
Contact Us
For immediate assistance with your Progesterone Micronized Powder USP inquiry, contact our dedicated pharmaceutical team at duke@hongdaherb.com. We're committed to supporting your success with reliable supply, competitive pricing, and exceptional service.
contact us:📩 duke@hongdaherb.com
Download Resources: USP Monograph | SDS | Formulation Guide
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