Medroxyprogesterone Acetate Powder Supplier China | ≥99% API Manufacturer CAS 71-58-9
Key Features
✅ ≥99% HPLC Purity, Synthetic Progestogen API (CAS 71-58-9)
✅ GMP-Aligned Steroid API Manufacturing with Full Batch Traceability
✅ Batch COA, HPLC Report, MSDS & TDS Provided for Every Order
✅ Custom Micronization Available (D90 ≤10 μm / ≤5 μm) for Injectable Suspensions
✅ Flexible Supply from 1g Samples to 25 kg+ Commercial Batches
✅ Global Export to 70+ Countries with Complete Customs Documentation
What Is Medroxyprogesterone Acetate?
Medroxyprogesterone Acetate Powder (MPA) is a synthetic progestogen derived from 17α-hydroxyprogesterone, with a 6α-methyl substitution that enhances oral bioavailability. Our pharmaceutical-grade MPA is a white to off-white powder with assay ≥99% by HPLC, manufactured under GMP-aligned steroid synthesis and multi-stage HPLC purification. It is freely soluble in methylene chloride, soluble in acetone, sparingly soluble in ethanol, and practically insoluble in water.
HDM BIO supplies MPA from 10 g research samples to 25 kg+ commercial batches, with custom micronization, OEM synthesis, and full technical documentation for global pharmaceutical companies, research institutions, and distributors.
API intermediate for pharmaceutical formulation, research, and manufacturing use. Not a finished drug product; not for direct clinical administration.
COA & Quality Test Results
Every batch is tested in HDM BIO's in-house QC lab; a batch-specific COA is issued for every order.
| Test Item | Specification | Typical Result |
|---|---|---|
| Appearance | White to off-white powder | White to off-white powder |
| Identification | IR concordant with reference standard | Conform |
| Melting Point | 200–210°C | 205.8–207.1°C |
| Specific Optical Rotation | +56° to +66° | +61.2° |
| Loss on Drying | ≤0.5% | 0.12% |
| Related Substances (HPLC) | Single ≤0.5%; Total ≤1.0% | Max single 0.18%; Total 0.42% |
| Residual Solvents (GC) | ICH Q3C limits | All within limits |
| Heavy Metals (ICP-MS) | ≤10 ppm | <5 ppm |
| Assay (HPLC, dried) | 97.0–103.0% | 99.6% |
| Particle Size (D90) | ≤100 μm (customizable) | 68 μm |
| Microbial Limits | TAMC ≤10³ CFU/g; pathogens absent | Conform |
What Is Medroxyprogesterone Acetate Used For?
MPA API is used as a raw material for:
- Oral & injectable dosage form development - subject to applicable pharmacopeial and regulatory requirements
- Contraceptive formulation research - long-acting injectable (DMPA) studies
- Endometrial & HRT research - progestin component formulation studies
- Analytical reference standard - pharmacopeial method validation
Medroxyprogesterone Acetate vs Other Progestogens
| Product | Type | CAS | Core Feature |
|---|---|---|---|
| Medroxyprogesterone Acetate | Synthetic progestogen | 71-58-9 | High oral & injectable potency; long-acting depot |
| Progesterone | Natural steroid hormone | 57-83-0 | Endogenous hormone; micronized oral |
| Megestrol Acetate | Synthetic progestogen | 595-33-5 | Strong antiandrogenic activity |
| Norethisterone | 19-Nortestosterone derivative | 68-22-4 | Androgenic activity; oral contraceptive component |
| Levonorgestrel | 19-Nortestosterone derivative | 797-63-7 | Very high potency; long-acting implant |
| Dydrogesterone | Retroprogesterone derivative | 152-62-5 | Pure progestogenic; no androgenic activity |
What Supply Options Are Available?
| Supply Type | Availability |
|---|---|
| Analytical reference standard sample | Yes |
| Small research batch (10 g – 100 g) | Yes |
| Medium-batch production (1 kg – 10 kg) | Yes |
| Large-scale bulk API supply (25 kg +) | Yes |
| Custom micronization (D90 ≤10 μm / ≤5 μm) | Yes |
| Custom derivative synthesis | Yes |
Prices are negotiable based on order quantity. Contact sales for bulk quotation and lead time.
What Should Buyers Verify Before Purchasing MPA API?
| Buyer Check | HDM BIO Documentation / Test Method |
|---|---|
| HPLC Assay | Batch COA |
| Related Substances Profile | HPLC Report (individual & total impurities) |
| Identity Confirmation | IR / LC-MS |
| Residual Solvents | GC (ICH Q3C) |
| Heavy Metals / Elemental Impurities | ICP-MS (ICH Q3D) |
| Particle Size Distribution | Laser Diffraction |
| Optical Rotation | Batch Test |
| Melting Point | Batch Test |
| Storage Stability | Stability Data (real-time & accelerated) |
| Production Traceability | Batch Records & Deviation Logs |
| Export Compliance | Shipping Documentation & Certificate of Origin |
| Microbiological Quality | TAMC / TYMC / Pathogen Screening |
Why Choose HDM BIO?
- 10+ years of steroid hormone API manufacturing experience
- Full batch traceability for every production lot
- GMP-aligned clean production workshops with standardized synthesis and purification lines
- Global export experience covering 70+ countries and regions
- ISO & HACCP certified quality management system
- Professional technical team for R&D consultation and formulation guidance
- Flexible sample trials and bulk OEM customization
- Fast global air & sea logistics
Storage & Handling
- Storage: Store tightly sealed at 2–8°C, protected from light and moisture.
- Handling: Avoid exposure to humidity and direct light; weigh in a dry environment; minimize air exposure.
- Shelf Life: 2 years under proper sealed storage conditions.
- Safety: For laboratory research and pharmaceutical R&D use only. Not for direct human or animal clinical use.
FAQ
Q: What is Medroxyprogesterone Acetate?
A: Medroxyprogesterone Acetate powder is a synthetic progestogen derived from 17α-hydroxyprogesterone, used as a steroid hormone API raw material in pharmaceutical research and formulation development.
Q: What is the CAS number?
A: CAS 71-58-9. Molecular formula C₂₄H₃₄O₄; molecular weight 386.52 g/mol.
Q: What is the difference between MPA and Progesterone?
A: Progesterone is the natural endogenous hormone. MPA is a synthetic derivative with higher potency and oral bioavailability, available as a long-acting injectable depot.
Q: What is the difference between MPA and Megestrol Acetate?
A: Both are 17α-hydroxyprogesterone derivatives. MPA has a 6α-methyl group; megestrol has a 6-methylene group. Megestrol is more studied for breast cancer; MPA is more widely used for contraception and HRT research.
Q: How is MPA purity tested?
A: By HPLC (assay and related substances), with identity confirmed by IR/LC-MS. Additional testing includes residual solvents (GC), elemental impurities (ICP-MS), optical rotation, and particle size (laser diffraction).
Q: What particle size options are available?
A: Standard D90 ≤100 μm. Custom micronized grades D90 ≤10 μm or ≤5 μm for injectable suspensions.
Q: What documentation comes with each order?
A: Batch COA, HPLC report, MSDS, and TDS. ISO/HACCP certificates available on request.
Q: What is the MOQ and where to buy bulk?
A: From 1 g samples to 25 kg+ bulk. HDM BIO supplies directly from China with tiered pricing, complete documentation, and global delivery. Contact us for a quote.
factory
Certificates
Shipping & Packing
Request COA / Sample / Bulk Quote
High-purity Medroxyprogesterone Acetate powder ≥99%, fully qualified, stable quality, flexible supply. Ideal for pharmaceutical formulation, research, and cosmetic raw material applications.
Free samples, bulk quotations, and competitive pricing available.
Contact:
Whatsapp & Mobile: +8619991242181
Email:sales@hdmbio.com
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