1. Product Introduction
Progesterone is a core steroid hormone mainly secreted by the ovarian corpus luteum and is an essential endocrine hormone for female physiological health and reproductive regulation. Female endocrine system relies on complex excitation and inhibition signal coordination to regulate menstruation and fertility. Progesterone works synergistically with estrogen to control multiple organ functions related to the menstrual cycle, maintaining female endocrine balance and normal reproductive physiological activities.
Our high-purity Progesterone Powder presents white or almost white odorless crystalline powder with stable physical and chemical properties. The product strictly complies with EP10 and USP43 international pharmacopoeia standards, with ultra-high purity and low impurity content, widely used in pharmaceutical raw material preparation, clinical treatment and assisted reproductive technology fields.
2. Complete COA Quality Test Report
According to EP10
| Items | Requirements | Results |
| Ref standard | According to EP10 | |
| Purity | ≥99.2% | 99.78% |
| Assay | 97%-102% | 99.21% |
| Appearance | White or almost white crystalline powder,odorless | Conforms |
| Identification | A:IR B:TLC | Conforms |
| Melting point | 126℃-131℃ | 128℃-129.1℃ |
| Loss on drying | ≤0.5% | 0.17% |
| Specific optical rotation | +186°~+194° | +188° |
| Single impurity | ≤0.5% | 0.18% |
| Total impurities | ≤0.8% | 0.22% |
| Conclusion: | The items tested conform to the requireaents of EP10 | |
According to USP43
| Item | Requirements | Results |
| Appearance | White or almost white crystalline powder | Conforms |
| Standard | USP43 | / |
| Assay | 97%-103% | 99.15% |
| Particle size | 90%＜10UM | Conforms |
| Specific optical rotation | +175°~+183° | +181° |
| Loss on drying | ≤0.5% | 0.17% |
| Melting point | 126℃-131℃ | 127℃-129.2℃ |
| Identification | A:IR B:UV | Conforms |
3. Core Physiological Functions & Efficacy
As a key regulatory hormone for female reproduction and endocrine, progesterone has multiple core clinical and physiological functions, widely applied in gynecological regulation and reproductive health care:
1. Maintain Pregnancy & Protect Fetal Development
Progesterone promotes the growth and development of uterine mucosal glands, thickens and protects the endometrium, and creates a stable implantation environment for fertilized eggs. It effectively inhibits uterine contraction, reduces uterine sensitivity to oxytocin, avoids excessive uterine excitement, and provides stable nutritional and environmental support for early fetal growth, which is the core hormone for maintaining normal pregnancy and reducing the risk of threatened abortion.
2. Promote & Maintain Breast Health Development
It cooperates with estrogen to promote the normal structural development of female mammary glands, maintain the physiological stability of breast tissue, and lay a foundation for subsequent lactation function, which is essential for female breast physiological health maintenance.
3. Treat Gynecological Endocrine Disorders
It is clinically used to improve dysfunctional uterine bleeding caused by corpus luteum insufficiency, regulate menstrual cycle disorders caused by insufficient progesterone secretion, and effectively solve a variety of sub-health gynecological problems caused by endocrine imbalance.
4. Auxiliary Clinical Diagnosis
Progesterone detection and supplementation assistance can effectively evaluate ovarian corpus luteum function, judge ovulation status, and provide accurate data support for clinical diagnosis of threatened abortion, ovulatory dysfunction and other reproductive diseases.
4. Wide Application Fields
1. Pharmaceutical Raw Material Preparation
High-purity progesterone powder is a core raw material for the production of progesterone pharmaceutical preparations, supporting the processing of multiple dosage forms such as injections and oral tablets. It is the basic raw material for standardized gynecological hormone drugs.
2. Clinical Medical Treatment
Clinically applicable to the treatment of threatened abortion, habitual abortion, premenstrual tension syndrome, anovulatory amenorrhea, luteal insufficiency and other common gynecological diseases, with definite curative effect and stable safety.
3. Assisted Reproductive Technology
Widely used in assisted reproduction cycles, it regulates female endocrine levels, optimizes endometrial receptivity, improves fertilized egg implantation rate, and assists in improving the success rate of assisted reproduction.
5. Product Advantages
Dual Pharmacopoeia Compliance: The product meets both EP10 European Pharmacopoeia and USP43 United States Pharmacopoeia standards, with global universal qualification, suitable for international pharmaceutical and medical fields.
Ultra-High Purity & Low Impurity: The main purity is up to 99.78%, total impurities as low as 0.22%, far exceeding the standard limit, with stable medicinal activity and high safety.
Stable Physical Properties: Qualified moisture content, stable optical rotation and melting point, uniform particle size, good solubility and compatibility, convenient for pharmaceutical formulation processing.
Professional Medical Grade: Strict pharmaceutical-grade production standards, controllable batch difference, fully meeting clinical medical and biopharmaceutical raw material application requirements.
Reference
[1].Putnam CD, Brann DW, Kolbeck RC, Mahesh VB. Inhibition of uterine contractility by progesterone and progesterone metabolites: mediation by progesterone and gamma amino butyric acidA receptor systems. Biol Reprod. 1991 Aug;45(2):266-72.
[2]. Lawrenz B., Melado L., Fatemi H. Premature Progesterone Rise in ART-Cycles. Reprod. Biol. 2018;18:1–4. doi: 10.1016/j.repbio.2018.01.001.
6. Packaging & Storage
Packaging: Standard pharmaceutical-grade export packaging, support customized specifications according to customer demand.
Storage Conditions: Store in a cool, dry, dark and dust-free clean environment, keep tightly sealed, avoid high temperature, strong light and damp environment to ensure long-term stability of product activity.
FAQ
Q1: What pharmacopoeia standards does your progesterone powder meet?
A: Our products fully comply with EP10 European Pharmacopoeia and USP43 United States Pharmacopoeia dual international standards, with complete test indicators and universal global applicability.
Q2: What is the main application of high-purity progesterone powder?
A: It is mainly used as pharmaceutical raw materials for gynecological hormone drugs, clinical treatment of reproductive endocrine diseases, and raw material support for assisted reproductive technology.
Q3: What is the purity level of your product?
A: The product EP standard purity reaches 99.78%, with extremely low single and total impurities, belonging to high-purity medical-grade progesterone powder.
Q4: Is the product batch stable for long-term bulk supply?
A: Yes. We have standardized pharmaceutical production workshops, stable production technology and controllable batch differences, supporting long-term stable bulk export supply.
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