Description

Technical Parameters

Introduction

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Products Description

### Systematic Introduction to Progesterone Raws Powder

Progesterone is an important endogenous steroid hormone that plays a core role in reproductive health, pregnancy maintenance and endocrine regulation. As a raw powder, progesterone is widely used in medicine, scientific research and industry. This article will comprehensively explain the classification, chemical properties, preparation methods, application fields, quality control and market status.

### 1. Chemical basis and classification basis of progesterone

#### 1. Chemical structure and physical and chemical properties

- **Chemical name**: Pregnane-4-ene-3,20-dione

- **Molecular formula**: C₂₁H₃₀O₂

- **Molecular weight**: 314.46

- **CAS number**: 57-83-0

- **Melting point**: 128.5–131.5°C

- **Solubility**: Easily soluble in ethanol, acetone, chloroform, slightly soluble in vegetable oil, almost insoluble in water.

- **Stability**: Light-sensitive, need to be stored away from light; easy to oxidize, need inert gas protection.

#### 2. Classification Standards

The classification of progesterone raw material powder is mainly based on **source**, **purity level** and **application field**, as follows:

### 2. Classification by source

#### 1. Naturally extracted progesterone

- **Source**:

Steroidal precursors (such as diosgenin) extracted from animals (such as pig ovaries, placenta) or plants (such as yam, soybean) are obtained through biotransformation.

- **Advantages**:

- High biocompatibility and low risk of side effects;

- Suitable for patients who are sensitive to synthetic hormones;

- Meet the market demand for natural medicines.

- **Disadvantages**:

- Complex extraction process and high cost;

- Purity is usually lower than synthetic products (90–98%);

- Susceptible to differences in raw material batches.

#### 2. Chemical synthesis of progesterone

- **Process**:

Cholesterol or phytosterol is used as raw material, and it is prepared by microbial fermentation (such as using black root mold) or full chemical synthesis (such as marker degradation reaction).

- **Advantages**:

- Purity is as high as 99% or more;

- Large-scale production is stable and cost-controllable;

- Customizable derivatives (such as 17α-hydroxyprogesterone).

- **Disadvantages**:

- Synthesis intermediates may remain;

- Impurities (such as heavy metals and solvent residues) need to be strictly regulated.

### 3. Classification by purity level

#### 1. Pharmaceutical Grade

- **Standard**:

It meets the standards of the United States Pharmacopoeia (USP), European Pharmacopoeia (EP) or Chinese Pharmacopoeia (ChP), with a purity of ≥99.5%.

- **Key indicators**:

- Related substances (impurities) ≤ 0.5%;

- Microbial limits meet sterility requirements;

- Heavy metals (such as lead, arsenic) ≤ 10ppm.

- **Application**:

Used in the production of injections, oral tablets, vaginal suppositories and other preparations.

#### 2. Industrial Grade

- **Purity**: 95–98%

- **Use**:

- Cosmetic additives (must comply with the "Cosmetic Safety Technical Specifications");

- Animal feed hormone supplements;

- Chemical intermediates (such as synthesis of other steroid drugs).

#### 3. Laboratory Grade (Research Grade)

- **Features**:

- Purity ≥ 98%, but does not need to meet pharmacopoeia standards;

- Provide detailed certificate of analysis (COA), including HPLC spectrum, NMR data;

- Flexible packaging specifications (1g to 1kg).

- **Application**:

In vitro research (such as cell experiments), standard preparation, analytical method development.

### 4. Detailed explanation of application fields

#### 1. Medical field

- **Indications**:

- Threatened abortion caused by luteal insufficiency;

- Luteal support in assisted reproductive technology (ART);

- Hormone replacement therapy (HRT) during menopause.

- **Dosage form technology**:

Micronization process improves bioavailability (such as Utrogestan® oral capsules).

#### 2. Scientific research field

- **Research hotspots**:

- Progesterone receptor (PR-A/PR-B) signaling pathway mechanism;

- Neuroprotective effect (such as multiple sclerosis research);

- Cancer correlation (breast cancer and progesterone metabolism association).

#### 3. Industrial field

- **Derivative development**:

Synthesize drugs such as medroxyprogesterone acetate (MPA, CAS 71-58-9), dydrogesterone (CAS 152-62-5).

### 5. Quality control and safety specifications

#### 1. Analytical method

- **HPLC**:

Reverse phase C18 column, mobile phase methanol-water (70:30), detection wavelength 241nm.

- **Mass spectrometry (LC-MS)**:

Used to identify trace impurities (such as Δ4 isomer).

#### 2. Safety and storage

- **Toxicity data**:

LD₅₀ (rat oral) ＞5000mg/kg, which is low toxicity, but long-term overdose may cause endocrine disorders.

- **Storage conditions**:

2–8°C, sealed and protected from light, humidity <40%; nitrogen protection is recommended for long-term storage.

#### 3. Regulatory requirements

- **GMP certification**:

Pharmaceutical-grade production must comply with FDA 21 CFR Part 211 or EU GMP Annex 1.

- **Import and export control**:

Listed in the Appendix of the United Nations Convention against Illicit Traffic in Narcotic Drugs, and an import and export license must be applied for.

### 6. Market status and manufacturers

#### 1. Major manufacturers

- **International**:

Pfizer (USA), MERCK KGaA (Germany), Zhejiang Xianju Pharmaceutical (China).

- **Raw material supply chain**:

China accounts for more than 60% of the global steroid API production capacity, relying on its saponin resource advantages.

#### 2. Price factors

- Pharmaceutical grade: $800–$1200/kg (quote in 2023);

- Industrial grade: $300–$500/kg;

- Significantly affected by saponin price fluctuations and environmental protection policies.

### 7. Future development trends

1. **Green synthesis technology**:

Develop enzyme catalysis processes (such as using cytochrome P450 monooxygenase) to reduce environmental pollution.

2. **Nanoformulation application**:

Liposome encapsulation of progesterone improves targeting and reduces systemic exposure risk.

3. **Personalized medicine**:

Progesterone dosage optimization based on genetic testing (such as CYP3A4 metabolic enzyme polymorphism study).

### Conclusion

As the core substance in the field of steroid hormones, the classification and application of progesterone raw material powder need to be comprehensively considered in combination with scientific needs and regulatory frameworks. With the advancement of biotechnology and green chemistry, the production of progesterone in the future will be more efficient and environmentally friendly, and will play a greater role in precision medicine.