Procurement Report: Stanolone (5α-Androstan-17β-ol-3-one)

Product Category: Chemical Reference Materials / Analytical Standards / Research Reagents CAS Number: 521-18-6 Chemical Name: 5α-Androstan-17β-ol-3-one (also known as Dihydrotestosterone or DHT in specific contexts, though Stanolone is the specific 5α-reduced form)

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1. Technical Specifications and Performance Metrics

Stanolone (5α-Androstan-17β-ol-3-one) is a saturated derivative of testosterone, characterized by the absence of the double bond at the C4-C5 position. For procurement purposes, the primary technical focus is on purity, stereochemistry, and physical state, as these determine its efficacy in analytical chemistry and biological research.

• Purity Standards:
  • Typical B2B Range: ≥97.0% to ≥99.5% (HPLC or GC analysis).
  • Certified Reference Materials (CRM): Often guaranteed at ≥97.5% with traceability to NIST or equivalent standards.
  • Impurity Limits: Heavy metals <10 ppm; Residual solvents (e.g., Methanol) <0.1% for analytical grades.
• Physical Properties:
  • Appearance: White to off-white crystalline powder.
  • Solubility: Poorly soluble in water; highly soluble in organic solvents such as methanol, ethanol, chloroform, and acetone.
  • Storage Stability: Stable under inert atmosphere at -20°C; typical shelf life of 24–36 months when stored correctly.
• Performance Metrics:
  • Analytical Accuracy: Certified Reference Materials (e.g., TraceCERT®) provide an uncertainty range of <1% for quantitative analysis.
  • Batch-to-Batch Consistency: Critical for longitudinal studies; suppliers typically provide a Certificate of Analysis (CoA) with specific batch data.

Procurement Recommendation: Prioritize suppliers who provide a full Certificate of Analysis (CoA) with specific chromatographic data (HPLC/GC) for every batch. For high-precision mass spectrometry or immunoassay calibration, select "Certified Reference Material" grades over general "Research Grade" to ensure traceability and minimize analytical error.

2. Industry Compliance and Quality Assurance

The procurement of Stanolone is heavily regulated due to its classification as an androgenic anabolic steroid precursor and its use in controlled substance analysis. Compliance is not optional but a prerequisite for legal operation.

• Regulatory Status:
  • Controlled Substance: In many jurisdictions (including the US under the Controlled Substances Act), DHT/Stanolone derivatives are regulated. Procurement requires verification of the buyer's license (e.g., DEA registration in the US) if intended for human/animal use or specific forensic applications.
  • Exempt Preparations: Some suppliers offer "exempt preparations" (e.g., ≤1mg quantities) for research purposes that may bypass certain licensing hurdles, but this varies by region.
• Quality Certifications:
  • ISO 17034: Essential for Certified Reference Material (CRM) producers to ensure the validity of the reference value.
  • ISO 9001: Indicates general quality management system compliance.
  • TraceCERT® / Cerilliant®: Specific brand lines indicating compliance with strict metrological standards.
• Documentation Requirements:
  • Batch-specific CoA.
  • Material Safety Data Sheet (MSDS/SDS).
  • Chain of Custody documentation for high-value CRMs.

Procurement Recommendation: Verify the supplier's ability to provide regulatory documentation specific to your jurisdiction before placing an order. For research institutions, ensure the supplier explicitly states the "For Research Use Only" (RUO) status unless a specific license is held. Avoid sourcing from unverified marketplaces to mitigate the risk of counterfeit or non-compliant stock.

3. Cost Efficiency and Integration Capabilities

Cost analysis for Stanolone must balance unit price against the required precision level. The market shows a significant price disparity between bulk research grades and certified reference standards.

• Pricing Structure (Based on Market Data):
  • Micro/Exempt Scale (1mg): ~$54.00 – $54.00 (High cost per mg, intended for initial screening or exempt research).
  • Standard Analytical Scale (1g): ~$94.80 (Approx. $94.80/g).
  • Certified Reference Scale (100mg): ~$767.00 (Approx. $7,670/g; high cost due to certification overhead).
  • Bulk Scale (10g): ~$567.00 (Approx. $56.70/g; best value for large-scale method development).
• Integration Capabilities:
  • Solvent Compatibility: Available in solid form or pre-dissolved solutions (e.g., 1.0 mg/mL in methanol), facilitating immediate integration into LC-MS/MS workflows without user preparation.
  • Packaging: Ampoules (glass) for solutions; sealed vials for solids.
• MOQ and Lead Time:
  • MOQ: Typically 1 unit (1mg to 10g) for research suppliers.
  • Lead Time: Standard inventory items (1g, 10g) often ship within 3–5 business days. Custom or certified batches may require 2–4 weeks.

Procurement Recommendation: For routine calibration, purchase the 1g or 10g bulk grades to achieve the lowest cost per mg. Reserve the expensive Certified Reference Materials (CRMs) strictly for regulatory compliance, method validation, or when external accreditation is required. Utilize pre-dissolved solutions (e.g., 1mL ampules) only if the specific concentration matches your workflow to avoid dilution errors.

4. Typical Use Cases

Stanolone is a niche but critical reagent in specialized scientific fields. Its applications are almost exclusively non-clinical in the procurement context, focusing on analysis and research.

• Forensic Toxicology: Used as a positive control or calibration standard to detect androgenic doping in athletes or to identify illegal steroid use in biological samples (urine/blood).
• Metabolomics and Pharmacokinetics: Serves as a reference standard for studying the metabolism of testosterone and other androgens, specifically the 5α-reduction pathway.
• Mass Spectrometry (LC-MS/MS): Essential for building calibration curves and verifying instrument sensitivity for androgen detection.
• Receptor Binding Assays: Used in vitro to study androgen receptor affinity and selectivity.
• Quality Control: Used by pharmaceutical manufacturers to verify the purity of precursor materials in steroid synthesis.

Procurement Recommendation: Define the specific application before purchasing. If the goal is forensic validation, insist on a CRM with a defined uncertainty value. If the goal is internal method development, a high-purity (≥97.5%) research grade is sufficient and more cost-effective.

5. Long-Term Planning Considerations

The market for androgenic reference standards is subject to regulatory shifts and supply chain constraints.

• Market Trends:
  • Increased Regulatory Scrutiny: Stricter doping control regulations globally are driving demand for higher precision CRMs.
  • Supply Chain Volatility: As a controlled substance precursor, supply can be interrupted by sudden regulatory changes or export restrictions in manufacturing regions (e.g., China, Germany, Korea).
  • Demand Signals: Rising interest in "anti-aging" research and forensic doping analysis suggests a steady, long-term demand for high-purity DHT/Stanolone.
• Inventory Strategy:
  • Maintain a buffer stock of 1g or 10g bulk grades (typical shelf life 24+ months) to mitigate supply shocks.
  • Avoid holding large quantities of CRMs unless necessary, as their certification dates may expire, rendering them less valuable for accreditation.
• Risk Mitigation:
  • Diversify suppliers across different geographic regions (e.g., US-based Sigma-Aldrich, European, Asian suppliers) to reduce dependency on a single source.

Procurement Recommendation: Adopt a "Just-in-Case" inventory strategy for bulk research grades (1g–10g) while maintaining a "Just-in-Time" approach for certified reference materials. Monitor local regulatory announcements regarding anabolic steroids to anticipate potential import/export delays.

6. Special Product Recommendations

The following table compares available product formats based on the search context, helping buyers select the optimal SKU for their specific needs.

| Product Type | Best-Fit Buyer | Key Specs | Risk Check | Procurement Advice | | :--- | :--- | :--- | :--- :--- | | Certified Reference Material (CRM) | Accredited Labs, Forensic Units | ≥97.5% Purity, TraceCERT®/Cerilliant® certified, 100mg | High Cost ($767/100mg), Regulatory Scrutiny | Purchase only when external validation is required. Verify the CoA traceability chain. | | Research Grade (Bulk) | R&D Departments, Universities | ≥97.5% Purity, 1g or 10g | Standard purity variance | Best value for internal method development. 10g offers ~40% cost savings vs 1g. | | Pre-dissolved Solution | High-Throughput Labs | 1.0 mg/mL in Methanol, 1mL Ampule | Solvent degradation over time | Ideal for immediate LC-MS/MS calibration. Check expiration date upon receipt. | | Exempt Preparation | Small Research Groups | ≥97%, 1mg | Low quantity limits | Good for initial screening. Verify "exempt" status in your local jurisdiction to avoid licensing issues. |

Procurement Recommendation: For most procurement scenarios, the Research Grade (1g or 10g) offers the best balance of cost and performance. Only upgrade to CRM if the specific application demands metrological traceability for accreditation purposes.

7. Frequently Asked Questions (FAQ)

Q1: What is the difference between Stanolone and DHT? A: Chemically, Stanolone is the common name for 5α-Androstan-17β-ol-3-one, which is identical to Dihydrotestosterone (DHT). The term "Stanolone" is often used in specific pharmaceutical or research contexts to distinguish the 5α-reduced form from other testosterone derivatives.

Q2: Is a license required to purchase Stanolone? A: In many countries, including the US, Stanolone/DHT is a controlled substance. Purchasing it for human use or specific research may require a DEA license or equivalent regulatory permit. Always check local laws before ordering.

Q3: What is the typical shelf life of Stanolone? A: When stored in a cool, dry place (ideally -20°C) under an inert atmosphere, Stanolone typically has a shelf life of 24 to 36 months. Pre-dissolved solutions in methanol may have a shorter stability period (12–24 months).

Q4: Can I use the 1mg "Exempt Preparation" for calibration curves? A: Generally, no. The 1mg quantity is intended for initial screening or exempt research. Calibration curves typically require larger quantities (e.g., 1g) to prepare serial dilutions with sufficient precision and to ensure the stock solution remains stable over time.

Q5: What is the minimum order quantity (MOQ)? A: For most specialized chemical suppliers, the MOQ is 1 unit, which can range from 1mg to 100mg depending on the product grade. Bulk orders (10g) are often available but may require a formal purchase order.

Q6: How do I verify the purity of the product upon receipt? A: You should receive a Certificate of Analysis (CoA) with the shipment. Verify the batch number on the CoA matches the vial. For critical applications, perform an independent HPLC or GC-MS analysis to confirm the ≥97.5% purity claim.

Q7: Is Stanolone soluble in water? A: No, Stanolone is hydrophobic and has very poor solubility in water. It is typically dissolved in organic solvents like methanol, ethanol, or DMSO for laboratory use.

Q8: What are the storage requirements for the 10g bulk powder? A: Store in a tightly sealed container, protected from light and moisture, at temperatures between -20°C and 4°C. Avoid exposure to air to prevent oxidation or degradation.