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Progesterone

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Progesterone pharmaceutical raw material
Quick Facts
CAS Number57-83-0
Molecular FormulaC21H30O2
Molecular Weight314.469
PharmacopoeiaEP
Packaging25 KG/DRUM
USP Standard EP/BP Standard GMP Certified

Product Story

Progesterone was discovered through a series of breakthroughs between 1929 and 1934. Willard Myron Allen and George Washington Corner at the University of Rochester first isolated crude extracts from sow corpora lutea in 1929, demonstrating that this "progestin" maintained pregnancy in ovariectomized rabbits. The pure crystalline hormone was isolated independently in 1934 by four separate laboratories: Adolf Butenandt in Danzig, Karl Slotta in Breslau, Heinrich Ruschig at IG Farben, and the Allen-Wintersteiner group. Butenandt would later receive the 1939 Nobel Prize in Chemistry for his work on sex hormones. The name "progesterone" — combining "progestational" with the steroidal "-one" suffix — was proposed by Allen at the 1935 Second International Conference on the Standardization of Sex Hormones.

Progesterone's mechanism centers on its role as the body's pregnancy-maintaining steroid. It binds to nuclear progesterone receptors (PR-A and PR-B), activating transcription of genes that prepare the endometrium for embryo implantation and suppress uterine contractility. In veterinary medicine, this same mechanism is harnessed for two primary purposes: to synchronize estrus in cattle by suppressing ovulation (negative feedback on GnRH), and to maintain early pregnancy by supporting the endometrial environment. The controlled removal of exogenous progesterone in synchronization protocols triggers a predictable wave of follicular growth, enabling timed artificial insemination (TAI) in entire herds within a narrow 24-48 hour window.

One distinguishing feature of progesterone as a veterinary API is its formulation versatility. Unlike many steroid hormones that are administered by injection only, progesterone is routinely delivered via intravaginal devices (CIDR, PRID), oral formulations, and injectable solutions. The progesterone-releasing intravaginal device (PRID/CIDR) is arguably the most impactful reproductive technology in cattle production — it transforms herd fertility management from a labour-intensive observational task (heat detection, which can miss up to 40% of estruses) into a scheduled, predictable protocol. A single CIDR device for cattle typically contains 1.38 g of progesterone and releases approximately 0.5-1.0 mg/day over a 7-14 day insertion period.

As of mid-2026, global progesterone API demand is driven by dairy intensification programs across South Asia, Brazil, and Africa, where timed AI protocols are expanding rapidly. The livestock sector accounts for a growing share, but progesterone also remains a key intermediate in the synthesis of other steroid APIs including corticosteroids and progestins. China is the dominant manufacturing source for progesterone API, with production concentrated in Zhejiang, Hubei, and Shandong provinces. KingWish supplies EP-standard progesterone suitable for both veterinary pharmaceutical formulation and as a synthetic intermediate, supported by GMP manufacturing and full batch documentation.

Quality Specifications

Assay (HPLC, dried basis)97.0% - 103.0%, per EP monograph
Melting Point128-132 °C (EP method)
Specific Optical Rotation+186° to +194° (c=1, ethanol, 25 °C)
Related Substances (HPLC)Individual impurity ≤ 0.5%, total impurities ≤ 1.0%
Residual SolventsCompliant with ICH Q3C; ethanol ≤ 5,000 ppm
GMP StatusManufactured under ICH Q7 GMP conditions

Veterinary Applications

Estrus Synchronization (Cattle)

Progesterone-releasing intravaginal devices (CIDR/PRID) for timed AI protocols in beef and dairy cattle. Standard CIDR contains 1.38 g progesterone, inserted for 5-14 days depending on protocol. Enables batch calving and genetic improvement.

Pregnancy Maintenance

Progesterone supplementation to support early pregnancy and prevent embryonic loss in cattle and sheep. Reduces early embryonic mortality by maintaining uterine quiescence and endometrial secretory function.

Additional Applications

  • Batch farrowing in swine: Progesterone-based protocols to synchronize farrowing, reducing stillbirth rates and enabling all-in/all-out management.
  • Out-of-season breeding: Progesterone priming for induction of estrus in anestrous ewes and goats during non-breeding season.
  • Steroid intermediate: Progesterone serves as a key precursor in the multi-step synthesis of corticosteroids (hydrocortisone, prednisolone) and synthetic progestins.

Sourcing Progesterone: Key Checks

Documentation

Request batch-specific CoA with HPLC assay, melting point, specific optical rotation, and related substances data. Verify GMP certificate scope explicitly covers steroid hormone APIs. For regulated markets, confirm active DMF filing status. A complete CoA should report individual impurity peaks, not just a "passes" statement.

Red Flags

Melting point below 128 °C indicates impurity contamination. Optical rotation outside EP range suggests stereochemical degradation. Unusually low prices often indicate non-GMP production or solvent-quality API packaged as pharma-grade. Suppliers unwilling to disclose plant origin of starting material (diosgenin/stigmasterol source) may have traceability gaps.

Packaging & Logistics

Standard: 25 KG/DRUM with inner food-grade PE liner. Progesterone is light-sensitive — confirm opaque outer packaging and sealed containers. Store at controlled room temperature (15-25 °C), protected from moisture. Standard lead time 4-8 weeks. Custom packaging sizes available on request.

Market Context

Global progesterone API market projected to grow at ~6% CAGR through 2035, driven by dairy intensification in South Asia and Brazil, plus expanding timed-AI adoption in Africa. China supplies the majority of global progesterone API. Steroid hormone APIs are a consolidated supplier landscape — product quality and regulatory filing depth separate Tier-1 suppliers from commodity traders. Market report

Frequently Asked Questions

Progesterone is primarily used for estrus synchronization in cattle via intravaginal devices (CIDR/PRID) in timed-AI protocols — a standard CIDR contains 1.38 g progesterone inserted for 5-14 days. It is also used for pregnancy maintenance to prevent early embryonic loss, batch farrowing synchronization in swine, and out-of-season breeding in small ruminants. Progesterone additionally serves as a key synthetic intermediate in corticosteroid and progestin API manufacturing.
Commercial progesterone API is produced via semi-synthesis from plant sterols, most commonly diosgenin extracted from Dioscorea (wild yam) species or stigmasterol from soy. This multi-step chemical conversion yields progesterone chemically identical to the endogenous hormone. Historically, progesterone was isolated from thousands of sow ovaries (Corner-Allen, 1929), but this yielded only milligrams of hormone per kilogram of tissue and was commercially unviable. Modern semi-synthesis provides pharma-grade progesterone at industrial scale.
The EP monograph specifies assay 97.0%-103.0% (HPLC, dried basis), melting point 128-132 °C, specific optical rotation +186° to +194°, individual impurities ≤ 0.5%, and total impurities ≤ 1.0%. USP standards are also applicable for the US market. Always request a batch-specific CoA showing all these parameters with actual numerical results — a CoA that only states "conforms" without HPLC chromatogram data or numeric values is a red flag. For regulated markets, confirm the supplier holds an active DMF for progesterone.
Progesterone API has a typical shelf life of 3-5 years when stored at controlled room temperature (15-25 °C), protected from light and moisture, in sealed airtight containers. Progesterone is photolabile — UV exposure causes photodegradation to 20-hydroxy derivatives that fail pharmacopoeia related-substances limits. Opaque packaging and dark storage conditions are critical throughout the supply chain. KingWish supplies progesterone in 25 KG/DRUM with inner food-grade PE liner and provides retest dates on every batch CoA.
Standards: EP  |  CAS: 57-83-0  |  Quality data verified against pharmacopoeia monograph COA and MSDS available  |  DrugBank  |  July 2026

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