Po de proxesterona micronizada

Micronized Progesterone Powder – Pharmaceutical-Grade API for HRT & ART Formulations

CAS 57-83-0 Shaanxi Hongda Phytochemistry Co., Ltd. is a cGMP Certified Po de proxesterona micronizada manufacturer and supplier in China for pharmaceutical and nutraceutical buyers in Europe, North America, Southeast Asia and Russia. Hongda has more than 20 years of production expertise, 20,000㎡ plant, 100,000-level purification workshops, and an annual output of 3,000 tonnes, guaranteeing stable purity at ≥99% (dry basis). Each batch is checked for particle size distribution (D90 < 10-20μm), heavy metals, microbiological and residual solvents before shipment. certificacións: cGMP, FDA, FSSC22000, ISO9001, HALAL, KOSHER, BRC.​​​​​​​

Introdución de produto

Progesterone (Pregn-4-ene-3,20-dione) is a natural C-21 steroid hormone identical to the progesterone produced by the human corpus luteum. Poor oral bioavailability is due to poor aqueous solubility and extensive first pass hepatic degradation of the standard progesterone crystal .

Air jet milling or wet milling mechanically reduces the particle size to the micrometre range. This greatly increases specific surface area which is, according the Noyes-Whitney equation, a factor in increasing dissolution rate. The net effect is a greatly enhanced bioavailability for both oral and vaginal administration modalities.

This makes the micronised form the gold-standard API for bio-identical Hormone Replacement Therapy (BHRT) and Assisted Reproductive Technology (ART)

Especificacións do produto

Informe de proba de terceiros

Shaanxi Hongda cooperates with the well-known third-party laboratories SGS and Eurofins in the world to independently evaluate the quality of products. Testing scope include:

· Testing for pesticide residues

· Confirmation of specific optical rotation

· Etiquetaxe nutricional

· Source report (natural/bio-identical)

· Any further tests requested by the purchasers

All test reports are available for your review upon request before ordering.

Micronized Progesterone Powder Advantages

Biodisponibilidade mellorada

Po de proxesterona micronizada is a standard BCS Class II drug: low solubility, high permeability. Micronization immediately overcomes the solubility bottleneck, enabling for efficient gastrointestinal absorption at lower doses.

First-pass metabolism reduced

The micronised form dissolves more quickly before it reaches the liver where the non-micronized oral progesterone is degraded and useless.

Consistent Dispersion in Formulation

Particle size D90 < 10-20μm provides a stable homogenous solution in oil-based and hydrophilic bases – crucial for softgel, vaginal suppository and cream formulations.

Bio-Identical Profile

It is structurally equivalent to natural progesterone and has less potential for androgenic or glucocorticoid adverse effects than manufactured progestins.

Compliance with Pharmacopoeia

Meets USP, EP and BP monograph criteria. Purity regulated between 97.0% - 103.0% (dry basis) and impurity profile strictly controlled.

Áreas de aplicación

Progesterone Micronised Powder finds extensive use in the following areas:

·Hormone Replacement Therapy (HRT) – oral capsules (e.g. Utrogestan-type) for perimenopausal and post-menopausal women

· Assisted Reproductive Technology (ART) : Luteal phase assistance in IVF procedures by oral or vaginal route

· Pregnancy Support: Prevents preterm birth and supports early pregnancy maintenance

· Compound Pharmacy: BHRT custom formulations (creams, troches, suppositories)

· Gynaecological Disorders: Handling irregular menses, luteal phase defect and amenorrhoea.

Proceso de Produción

Shaanxi Hongda production process is strictly monitored, aiming for pharmaceutical grade manufacture:

1. Raw Material Sourcing -- Verified authenticity and purity of starting materials traceable

2. Chemical Synthesis / Extraction — Under GMP-compliant circumstances

3. Micronization - Air jet milling to reduce particle size to D90 < 10–20 µm

4. Polymorphic Control – Alpha form stability maintained during processing

5. In-Process QC - Particle size distribution, assay & impurity checks at each stage

6. Final Testing – HPLC, GC, UV, Heavy Metals and Microbiological Testing

7. Acondicionamento - Double layer PE inside bag, fibre drum outer package, in the 100,000 grade clean rooms

Por que escoller Shaanxi Hongda?

· Established in 2001 with over 20 years of creating pharmaceutical quality extracts

• 20,000㎡ cleanroom with 100,000 level purifying workshops and 10+ production lines

· SGS standardised laboratory with HPLC, GC, UV and atomic absorption equipments

· Multi-standard certifications: cGMP, FDA, FSSC22000, ISO9001, ISO22000, HALAL, KOSHER, BRC, ORGANIC (EU & NOP)

· 3,000 tonnes annual capacity, 3,000㎡ warehouse and stable stock

· Third party verification by SGS and Eurofins on all product categories

Soporte OEM/ODM

Shaanxi Hongda offers one-to-one product customisation services for pharmaceutical and supplement brands. Your team can define:

· Target particle size distribution (D90 range)

· Pharmacopeial standard (USP, EP, BP or IP)

· Packaging format and batch size

· Private Label and Documentation Support (COA, MSDS, TDS)

Supported completed product formats are softgel capsules, hard capsules, tablets and pre-mixed powders. We normally deliver between 3-7 working days following order confirmation.

FAQ

Q1: What is the average particle size for your Micronised Progesterone Powder?

A: Our standard criteria is D90 < 10-20 micron. Custom particle size ranges available on request.

Q2: Your product meets the pharmacopeial criteria of which country?

A: The product is prepared per USP, EP and BP monographs with test values of 97.0%-103.0% on a dried basis.

Q3: What’s The Minimum Order Quantity (MOQ)?

A: MOQ is 25 kg (one drum) Standard. Samples of 20-100g are available for examination prior to placing large orders.

Q4: What is your method of shipping the product?

A: Net weight 25 Kg (gross weight 28 Kg) in a double layer of PE inner bag, in fibre drum. Each pallet has 27 drums.

Q5: Will you send the third party test reports before we place order?

A: Yes. Pesticide residue, particular optical rotation and purity reports from SGS and Eurofins are available upon request.

Q6: canto tempo dura o prazo de entrega?

A: Standard delivery is 3-7 business days once your order is confirmed. Expedited arrangements may be available, subject to current inventory.

Contacto

Ready to source pharmaceutical-grade progesterone for your next formulation with Po de proxesterona micronizadaEnvía a túa consulta a duke@hongdaherb.com.