Procurement Report: Tamoxifen Citrate (CAS 10540-29-1)

Product Category: Pharmaceutical Active Pharmaceutical Ingredient (API) / Research Chemical Primary CAS Number: 10540-29-1 Trade Name Reference: Nolvadex (Brand), TMX (Synonym) Primary Application: Research Use Only (RUO) – Estrogen Receptor Modulator

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1. Technical Specifications and Performance Metrics

This section outlines the critical physical and chemical parameters required for procurement of Tamoxifen (specifically the citrate salt form often associated with the trade name Nolvadex, though the CAS 10540-29-1 refers to the base form; procurement must clarify if the salt form is required for the specific application).

• Chemical Identity:

  • CAS Number: 10540-29-1
  • EC Number: 234-118-0
  • Molecular Formula: C₂₆H₂₉NO (Base); C₂₆H₂₉NO·C₆H₈O₇ (Citrate salt)
  • Purity Standards: Typical B2B research grade ranges from 98% to 99.5% (HPLC).
  • Appearance: White to off-white crystalline powder.
  • Solubility: Poorly soluble in water; soluble in ethanol, methanol, and DMSO.

• Performance Metrics:

  • Potency: High-affinity selective estrogen receptor modulator (SERM).
  • Stability: Stable under standard storage conditions (2-8°C) when protected from light.
  • Shelf Life: Typical B2B range of 24 to 36 months from date of manufacture when stored correctly.
  • Lot-to-Lot Consistency: Critical for in-vitro assays; variance should be <2% in purity.

• Procurement Recommendation:

  • Verify the specific salt form (Base vs. Citrate) with the supplier. While CAS 10540-29-1 is the base, clinical formulations often use the citrate salt. Ensure the Certificate of Analysis (CoA) explicitly states the salt form if the application requires the citrate moiety.
  • Demand a CoA with HPLC chromatograms for every lot to ensure >98% purity, as impurities can skew receptor binding assays.

2. Industry Compliance and Quality Assurance

Procurement of Tamoxifen requires strict adherence to safety and regulatory frameworks due to its classification as a potent pharmaceutical agent.

• Regulatory Classification:

  • OSHA HCS: Classified under the Hazard Communications Standard.
  • Usage Restriction: Explicitly designated for Research Use Only (RUO). It is not for human or veterinary diagnostic or therapeutic use.
  • Safety Data Sheet (SDS): Must be current (e.g., Revision date 10/07/2024 or newer).
  • Hazard Profile: Potential for delayed poisoning symptoms; medical observation for at least 48 hours is recommended in case of accidental exposure.

• Quality Assurance Requirements:

  • Supplier Verification: Suppliers must be reputable chemical manufacturers (e.g., Cayman Chemical, Selleck, etc.) with established QA/QC protocols.
  • Documentation: Mandatory provision of SDS, CoA, and Certificate of Origin for every shipment.
  • Handling: Procurement contracts must include clauses requiring suppliers to provide specific handling instructions for hazardous substances.

• Procurement Recommendation:

  • Do not purchase from general marketplaces without verified RUO status.
  • Ensure the supplier's SDS is available for download prior to order placement.
  • Implement internal safety protocols for receipt and storage, specifically noting the 48-hour medical observation window for potential exposure incidents.

3. Cost Efficiency and Integration Capabilities

• Pricing Structure:

  • Typical B2B Range: $150 – $450 per gram (Research Grade).
  • Bulk Pricing: Volume discounts typically apply for orders >100g, potentially reducing unit cost by 15-25%.
  • MOQ (Minimum Order Quantity): Typically 100 mg for research samples; 1 g for standard lab orders.

• Lead Times:

  • Standard Lead Time: 5 – 10 business days for in-stock items.
  • Custom Synthesis: 4 – 6 weeks if the specific salt form or high-purity grade is not in stock.

• Integration Capabilities:

  • Solvent Compatibility: Integrates seamlessly with standard organic solvents used in HPLC and cell culture media preparation (DMSO, Ethanol).
  • Packaging: Available in amber glass vials or HDPE bottles with desiccants to prevent moisture degradation.

• Procurement Recommendation:

  • Calculate total cost of ownership (TCO) including shipping and hazardous material handling fees, not just the unit price.
  • For long-term projects, negotiate a standing order agreement to lock in pricing and reduce lead times to 3-5 days.
  • Verify if the supplier offers "Just-in-Time" delivery options to minimize on-site storage of hazardous chemicals.

4. Typical Use Cases

• In-Vitro Research:

  • Mechanism of Action Studies: Used to block estrogen receptors in cell lines (e.g., MCF-7 breast cancer cells) to study proliferation inhibition.
  • Signal Transduction: Investigating downstream effects of ERα/ERβ modulation.

• In-Vivo Animal Studies:

  • Oncology Models: Administered to rodents to induce or treat hormone-dependent tumor models.
  • Endocrine Disruption Studies: Used to evaluate the impact of estrogenic compounds on reproductive systems.

• Chemical Synthesis:

  • Intermediate: Serves as a precursor in the synthesis of other complex pharmaceutical derivatives or labeled isotopes.

• Procurement Recommendation:

  • Align the purity grade with the application: >99% for in-vivo studies to minimize toxicological noise; >98% is generally acceptable for in-vitro screening.
  • Ensure the supplier can provide the specific salt form (Citrate) if the protocol requires the specific formulation used in clinical analogs.

5. Long-Term Planning Considerations

• Market Trends and Demand:

  • Oncology Research Growth: Increasing demand for SERM research due to the rising focus on breast cancer subtypes and resistance mechanisms.
  • Regulatory Tightening: Stricter global controls on the export/import of controlled substances and potent APIs may increase compliance costs.
  • Supply Chain Resilience: Reliance on a single manufacturer (e.g., Cayman Chemical) poses a risk; diversification is recommended.

• Risk Management:

  • Supply Disruption: Monitor global raw material availability for the diphenyl-1-buten-1-yl precursor.
  • Regulatory Shifts: Stay updated on changes to OSHA HCS and international transport regulations (IATA/IMDG) for hazardous chemicals.

• Procurement Recommendation:

  • Develop a "Dual-Source" strategy: Maintain relationships with at least two qualified suppliers to mitigate supply chain risks.
  • Allocate budget for compliance training for procurement and lab staff regarding the 48-hour medical observation protocol and SDS updates.
  • Plan for inventory rotation to ensure stock is used within the 24-36 month shelf life to avoid waste.

6. Special Product Recommendations

The following table compares potential procurement options based on buyer profile and specific needs.

| Product Type | Best-Fit Buyer | Key Specs | Risk Check | Procurement Advice | | :--- | :--- | :--- | :--- :--- | | Tamoxifen Base (CAS 10540-29-1) | Academic Labs / Mechanism Studies | Purity >98%, Powder form, Standard packaging | Low (Standard RUO) | Ideal for general receptor binding assays; verify if salt form is needed. | | Tamoxifen Citrate | Clinical Research / Formulation Dev | Purity >98%, Citrate salt, Stable in aqueous buffers | Medium (Requires specific handling) | Use only if the protocol mimics clinical Nolvadex; confirm salt form in CoA. | | High-Purity Isotope-Labeled | Advanced Pharmacokinetics | >98% Purity, C-13 or H-3 labeled | High (Cost & Availability) | Order well in advance (4-6 weeks lead time); strictly for mass spec/kinetic studies. | | Bulk Research Grade (10g+) | Large Scale Screening | Purity >98%, Bulk packaging, Cost-effective | Medium (Storage requirements) | Negotiate volume discount; ensure secure storage space for larger quantities. |

• Actionable Advice: For most standard research applications, the Tamoxifen Base is the most versatile and cost-effective choice. If the research specifically targets the pharmacokinetics of the commercial drug Nolvadex, the Citrate form is mandatory.

7. Frequently Asked Questions (FAQ)

Q1: Is Tamoxifen (CAS 10540-29-1) approved for human use? A: No. The product is strictly designated for Research Use Only (RUO). It is not for human or veterinary diagnostic or therapeutic use.

Q2: What is the difference between Tamoxifen Base and Tamoxifen Citrate? A: The Base (CAS 10540-29-1) is the active free amine. The Citrate is a salt form often used in commercial formulations (like Nolvadex) to improve solubility and stability. Procurement must specify which form is required for the assay.

Q3: What are the safety protocols if accidental exposure occurs? A: Symptoms may be delayed. Medical observation for at least 48 hours is required. Immediate contact with a medical professional and reference to the Safety Data Sheet (SDS) is mandatory.

Q4: What is the typical shelf life of Tamoxifen powder? A: When stored at 2-8°C and protected from light, the typical shelf life is 24 to 36 months from the date of manufacture.

Q5: Can I order small quantities (e.g., 100mg) for initial screening? A: Yes, most suppliers offer Minimum Order Quantities (MOQ) starting at 100 mg for research samples, with standard lead times of 5-10 business days.

Q6: Are there specific certifications required for importing this chemical? A: While specific certifications vary by country, the supplier must provide a current Safety Data Sheet (SDS) and Certificate of Analysis (CoA). Importers must comply with local hazardous material transport regulations (OSHA HCS, IATA).

Q7: How do I verify the purity of the product upon receipt? A: Cross-reference the received batch number with the provided Certificate of Analysis (CoA). The CoA should list HPLC purity (typically >98%) and specific impurity profiles.

Q8: What is the recommended storage condition for long-term stability? A: Store in a cool, dry place (2-8°C) in an amber container to protect from light and moisture. Ensure the container is tightly sealed to prevent degradation.