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Megestrol acetate (API)
Megestrol acetate (CAS 595-33-5, C₂₄H₃₂O₄, MW 384.51) is an off-patent synthetic steroidal progestin—a stable, crystalline, water-insoluble powder produced by chemical synthesis.
Uses: palliative treatment of advanced breast and endometrial cancer; first-line appetite stimulant for cancer/HIV cachexia; off-label hot-flash relief; veterinary estrus control; research and analytical reference standard.
API selling points: guideline-backed, recession-resistant demand across dual human and veterinary markets; no cold chain needed (ambient shipping); mature, scalable chemistry; tight impurity and residual-solvent profiles backed by full DMF/GMP/CTD dossiers; controlled particle size for dissolution-limited suspensions and nano-formulations; co-supply of pharmacopeial impurities and deuterated standards; plus strong batch-to-batch consistency and reliable lead times.
Caveats: prescription hormone only (thromboembolism, hyperglycemia, and adrenal suppression risks); never a supplement or bodybuilding ingredient; requires GMP status, contained handling, and proper disposal.
Specifications of Megestrol acetate CAS 595-33-5 COA:
Items | Specifications | Results |
Appearance | White to creamy white,tasteless and essentially odorless,crystalline powder | Conform |
Solubility | Insoluble in water,soluble in acetone,sparingly soluble in alcohol. | Conform |
Specific rotation | +8.8~+12° | +11.2° |
Melting point | 213-220℃ | 215.5-217.5℃ |
Water | ≤0.5% | 0.1% |
Residual on ignition | ≤0.2% | 0.08% |
Assay (HPLC) | 97.0~103.0% | 99.02% |
Related solvents | Methanol ≤3000 ppm Ethanol ≤5000 ppm Methylene chloride ≤600ppm | 68ppm Not detected 88ppm |
Micron | 100%≤20μm | 100%≤20μm |
Storage | Keep in tight container,protect from light,store at a temperature of 2℃ to 8℃. | |
Conclusion | The product conforms to the above specifications. | |
Product Name:Megestrol acetate
CAS:595-33-5
MF:C24H32O4
Melting point :214°C
form:powder
color:White to creamy white,tasteless and essentially odorless,crystalline powder
Uses:
Megestrol acetate is a synthetic steroidal progestin — a 17α-acetoxy-6-methyl derivative of progesterone with a Δ4,6-diene system. Unlike peptide hormones, it is a small, lipophilic, orally active molecule made by chemical synthesis (typically from 17α-hydroxyprogesterone acetate or progesterone via microbiological/chemical dehydrogenation and methylenation). It has been off-patent for decades and is a classic "evergreen" generic API.
Key identifiers & properties
| Item | Detail |
|---|---|
| CAS No. | 595-33-5 |
| IUPAC / synonyms | 17-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione; 6-dehydro-6-methyl-17α-acetoxyprogesterone; MGA |
| Molecular formula / weight | C₂₄H₃₂O₄ · 384.51 Da |
| EINECS / MDL | 209-859-9 · MFCD00056470 |
| Appearance | White to off-white crystalline powder |
| Melting point | 213–220 °C (USP range ≤3 °C spread); lit. 214–216 °C |
| Optical rotation | [α]D²⁰ +8.8° to +12.0° (c 2, CHCl₃, USP); lit. ≈+5° |
| UV max | ~287 nm (ethanol) |
| Solubility | Practically insoluble in water (~2 µg/mL at 37 °C); soluble in acetone/chloroform, sparingly soluble in ethanol |
| Stability / storage | Crystalline and chemically robust; preserve in well-closed containers, protected from light; ambient/cool & dry OK (unlike peptides, no cold chain needed) |
| Pharmacokinetics | Rapid oral absorption, Tmax ~2 h; elimination t½ ~23–33 h; metabolized to glucuronides, renal excretion |
| HS code | 2937.23 (steroid hormones) |
| Assay basis | Typically 97.0–103.0% (anhydrous basis, USP); water ≤0.5%, ROI ≤0.2%, heavy metals ≤20 ppm |
Main uses
1. Human clinical (prescription)
Palliative treatment of advanced/recurrent breast cancer and endometrial carcinoma (hormone-dependent tumors; not recommended as postoperative adjuvant therapy in breast cancer).
Appetite stimulation and treatment of cachexia/anorexia — in cancer patients and in AIDS-related wasting; this is now the largest-volume indication globally.
Off-label / supportive: hot-flash suppression in breast-cancer survivors (well documented), endometriosis, dysfunctional uterine bleeding/amenorrhea, historical use as the progestin component of combined oral contraceptives.
Dosage forms: tablets (e.g., 40 mg, 160 mg), dispersible tablets, capsules, soft capsules, and oral suspension 125 mg/mL (nanocrystal form with food-independent bioavailability). In China, the nanocrystal suspension entered the National Reimbursement Drug List (2025 edition, effective 1 Jan 2026), which is expanding demand for the API.
2. Veterinary
Estrus regulation/suppression in dogs (e.g., Ovaban), treatment of behavioral problems, induction of anestrus; also used in livestock reproduction management. One API, two regulated markets.
3. Research & analytical
Progesterone receptor (PR) agonist with AR antagonism and partial GR activity — used in hormone-dependent cancer cell studies (MCF-7, T47D), BPH/AR downregulation models, cachexia & neuropeptide-Y/appetite pathways, autophagy/catabolic pathway studies, HIV-wasting research.
Analytical reference standard for HPLC/LC-MS assay of finished products; EP/USP/BP provide extensive impurity reference sets (Impurities A–K, USP Related Compounds C/D/H…), so QC labs constantly need both the main standard and its impurities.
Selling points — API grade (what buyers actually pay for)
A. Market/commercial strengths
Off-patent, guideline-backed, recession-resistant demand — oncology supportive care + HIV cachexia are permanent needs; volumes are driven by aging populations and cancer incidence, not by fashion.
Dual revenue channel — same molecule feeds human generics (tablets/suspension) and veterinary products, plus reference-standard business.
Policy tailwinds — inclusion of the nanocrystal suspension in reimbursement lists (e.g., China NRDL 2026) lifts upstream API procurement; guidelines (CSCO) list megestrol as a first-line/I-class option for cancer anorexia-cachexia.
Low raw-material risk & mature chemistry — steroid backbone from plant/semi-synthetic sterol routes; synthesis is well understood, scalable from kg to tonne, with predictable cost. Competition is won on documentation and consistency, not molecule scarcity.
Excellent logistics economics — a stable crystalline solid shipped at ambient temperature in light-protected drums; no cold chain, no dry ice, low freight cost and low spoilage risk. This is a sharp contrast to peptide APIs.
B. Technical differentiators that win formulators & tenders
6. Particle-size engineering capability — because megestrol acetate is practically water-insoluble and absorption is dissolution-limited (especially for oral suspensions and nanocrystal/micronized products), offering controlled PSD (D10/D50/D90), narrow distribution, consistent crystal habit, and good flowability is the single biggest technical selling point. Supplying material qualified for nano-milling/suspension processing commands a premium.
7. Tight impurity/profile control — full identification & quantification of known steroid-related impurities/degradants (Δ1-dehydro, D-homo, 2α/2β-methyl, hydroxy, epimer, residual starting materials), individual unknowns ≤0.10%, total impurities well below monograph limits, with validated stability-indicating HPLC methods.
8. Residual solvents & genotoxic impurity control — ICH Q3C/Q3M compliant, nitrosamine risk assessment provided, elemental impurities (ICH Q3D), and low endotoxin/microbial limits for oral liquids.
9. Complete regulatory package — CTD Module 3 support, DMF/ASMF (US/EU), CEP where applicable, GMP certificate + inspection history, letter of access, real-time stability data (24–36 months, ICH zones II/IVb), and pharmacopeial compliance (USP-NF/EP/BP/ChP).
10. Batch-to-batch consistency & supply security — multi-line capacity, validated change control, retained samples, and guaranteed lead times. For a long-running generic, customers fear stock-outs more than price.
11. One-stop impurity & standard portfolio — co-supplying EP impurities A–K, USP related compounds, deuterated internal standards (e.g., megestrol acetate-D3) and working standards makes you a preferred vendor for QC departments.
12. Flexible packing & grading — pharma grade (GMP), non-GMP/pharma-intermediate grade, and research grade (≥98–99% HPLC) in 1 g–25 kg packs with fast dispatch; custom micronization and private-label COA support.
Important caveats to state honestly
Prescription hormone API only. Contraindications include known hypersensitivity, active or history of thromboembolic disease, severe hepatic impairment, hypercalcemia from bone metastases, and pregnancy/lactation. Risks: thrombosis/PE, edema, hyperglycemia, hypertension, adrenal suppression/Cushingoid effects, breakthrough uterine bleeding. All promotional copy must avoid therapeutic claims for unapproved uses.
Not a consumer/wellness product. Do not position it as a bodybuilding, "weight-gain," or anti-aging supplement. Its most visible side effect is weight gain precisely because of glucocorticoid activity — that also means it can mask illness and cause serious adverse events in healthy users. Research-grade material must carry "not for human/veterinary consumption."
Hormone handling & environment. Steroid APIs require contained handling (appropriate OEL/PPE), validated cleaning cross-contamination controls in shared facilities, and proper waste disposal to prevent environmental release.
Regulatory gatekeeping. Human use requires national marketing authorization plus GMP API with filed DMF; veterinary use has its own registrations and, in food-producing species, withdrawal-time considerations. Export/import may require permits.
Price quotes online vary wildly (from a few dollars to several hundred USD/kg) and many listings are unreliable traders. Real differentiators are verifiable: batch-specific COA + HPLC chromatogram, audit rights, and a traceable manufacturing site.
Also, if you have any other questions, you can contact us
FAQ From Wuhan Fortuna Chemical Co.,Ltd
Q1: Can I get a sample for free ?
A: For small QTY and low value product, we can provide sample for free exclude shipping cost. For high value sample, we will charge the basic sample cost, but we can refund all the cost if customers place order after sample test.
Q2: How to confirm the product quality before placing orders ?
A: Most of our products confirm to international standards like USP/EP/BP/JP/CP. We will provide COA/TDS/MSDS for customers to confirm the specification before placing order.
Q3: What is the payment you accept?
A: For small and low value order, we accept CreditCard, MaterCard,VISA,Western Union and T/T.For large order, we can do T/T and L/C. Any pay on delivery or pay-after are not available for us.
Q4: What is your shipment way ?
A: For less than 100kg gross weight order will ship with courier like FedEx or UPS, we support customers to place courier orders remotely by their account, we will package the goods well and wait for pick up.For more than 100kg goods, we will transport by Air or Sea according to customers' requirement.
Q5: How long is your after-sales service?
A: We accept customer’s quality complaint in three month after customer received the goods. We provide tech.support for all-life if customer place order from our company.
Q6: How do you treat quality complaint ?
A: We support customer to provide our products to any rightful third party testing organization to test our products according to the COA specification, if the test result is confirm with COA, we will take all the loss for customers.
Name:Wuhan Fortuna Chemical Co.,Ltd
Category:Others
Trade Category: Trading Company
Employees: 11 - 50 People
Address: Room 2015, No.2 Building, Kaixin Mansion No.107
Company Information: Wuhan Fortuna Chemical Co.,Ltd established in 2006, is a big integrative chemical enterprise being engaged in Pharmaceutical and Intermediates, Food and Feed additives, Fine chemicals,Biochemical and Reagent, which is the members of Hubei E-commerce Chamber.
Our company has professional persons who major in chemical R&D and sicentific management, supply fine chemical products with high quality and close service, also supply custom-tailored products according to our clients' requirement.
We have a positive and self-motivated management work team with a common philosophy, caring and commitment through teamwork, our team strive to achieve success in delighting our clients and ourselves.
Since Wuhan Fortuna Chemical Co., Ltd founded, we continuously innovate our products and improve our service, sales network. Hence, we initiate the first sale mode on net in China, which is the retail trade of small package bring along wholesale of diversified management modes. Our products are exported widely to South Korea, Vietnam, Australia, Europe and South America, highly recommended by our clients.We insist on the management creed “Market is our compass, Quality is our life, Credit is our soul”. Clients’ trust is our forward power, their satisfaction is our struggling goal.
Wuhan Fortuna Chemical Co.,Ltd is a professional manufacturer which provide Megestrol acetate with good quality and best price, welcome to contact us to get COA/TDS/MSDS of Megestrol acetate.
1. Guaranteed purity;
2. Large quantity in stock;
3. Largest manufacturer;
4. Best service after shipment with email;
5. High quality & competitive price;
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