Bulk Pharmaceutical API Sources for SODIUM CHROMATE CR-51

Bulk Pharmaceutical API Sources for SODIUM CHROMATE CR-51

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3080662
ABI Chem		AC1MIVGI
MuseChem		M055146
MuseChem		M119309
THE BioTek		bt-1185863
THE BioTek		bt-1213486

Bulk Active Pharmaceutical Ingredient (API) Sources for Sodium Chromate CR-51

Last updated: February 20, 2026

Sodium chromate CR-51 is a radiopharmaceutical agent primarily used as a diagnostic tracer for blood pool imaging and organ function assessments. The API sourcing landscape involves stringent quality, regulatory, and supply chain considerations.

What Are the Main API Suppliers for Sodium Chromate CR-51?

The API for sodium chromate CR-51 is produced by specialized chemical and radiopharmaceutical manufacturers. The key global suppliers include:

• Radiopharmaceutical Manufacturers: These companies produce the isotopic form (chromium-51), often sourcing the chemical precursor (sodium chromate) from established chemical suppliers.
• Chemical Companies with Radiolabeling Capabilities: These firms produce high-purity sodium chromate, which can be labeled with chromium-51.

Major API Producers

Company Name	Location	Capabilities & Notes	Regulatory Status
Isotope Products Laboratories (IPL)	USA	Produces chromium-51 sources, supplies the radiolabels	FDA-approved processes
PerkinElmer	USA/Europe (Offices)	Supplies chromium-51 isotopes, has GMP-certified labs	GMP-certified, licensed
GE Healthcare	Europe/USA	Produces radiopharmaceuticals including sodium chromate	EMA/FDA approval
Jubilant Radiopharma	India	Offers radiopharmaceutical production, including isotopic sodium chromate	DCGI-approved

Note: These companies often serve as the raw material providers or intermediaries that then supply the radiolabeled sodium chromate CR-51 for clinical use.

Sourcing Challenges and Quality Considerations

• Regulatory Approvals: Suppliers must hold relevant GMP certifications (FDA, EMA, DCGI) for pharmaceutical-grade sodium chromate.
• Isotope Supply Chain: Chromium-51 has a half-life of 27.7 days. Suppliers must maintain a reliable production schedule and logistics to ensure activity levels meet clinical demand.
• Purity Standards: API must be prepared with high chemical and radiochemical purity, typically exceeding 99% for chemical contaminants.
• Batch Consistency: Large-scale, validated production processes are necessary for batch-to-batch consistency and compliance with cGMP standards.

Supply Chain and Logistics

The bulk API often involves:

• Radioisotope Production: Typically carried out in specialized nuclear reactors or cyclotrons, such as those operated by Oak Ridge National Laboratory (USA) or European isotopic facilities.
• Conjugation Processes: The isotope is attached to chemical precursors, requiring controlled radiolabeling facilities.
• Transportation: Must comply with radiological regulations; shipping options are limited to licensed carriers.

Regulatory and Legal Aspects

Sodium chromate CR-51 API is classified as a radiopharmaceutical component. Its procurement involves:

• Licensing: Import/export licenses for radioactive substances.
• Quality Control: Batch testing for radiochemical purity, chemical purity, sterility, and endotoxins.
• Traceability: Full documentation for clinical and regulatory audits.

Summary

• The primary API sources for sodium chromate CR-51 include GMP-certified chemical suppliers, notably PerkinElmer, GE Healthcare, and regionally licensed producers like Jubilant Radiopharma.
• The radioactive isotope chromium-51 is produced in specialized facilities and supplied to radiolabeling centers.
• Supply chain integrity, regulatory compliance, and high-quality standards govern procurement.
• The API's supply is tightly controlled, with limited commercial sources due to the complexities of radioisotope handling.

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Key Takeaways

• Sodium chromate CR-51 API is supplied by a few specialized radiopharmaceutical companies with GMP-certified facilities.
• The chemical precursor is produced by established chemical suppliers, with chromium-51 sourced from nuclear reactors.
• Supply chain stability depends on isotope production schedules, logistic compliance, and strict regulatory adherence.
• High purity, batch consistency, and regulatory compliance are critical for clinical applications.
• Regulatory licensing for radioactive materials significantly influences procurement channels.

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FAQs

Q1: Which countries dominate sodium chromate CR-51 API production?
The USA and Europe host most production activities, with India serving as a regional supplier via firms like Jubilant Radiopharma.

Q2: What are the main regulatory hurdles for API procurement?
Licenses for radioactive materials, GMP certification, and adherence to import/export regulations are primary hurdles.

Q3: Is the API commercially available, or is it custom-produced?
It is generally available through specialized suppliers, often produced on a batch basis per clinical demand.

Q4: How does isotope half-life impact API sourcing?
Chromium-51’s 27.7-day half-life necessitates rapid logistics and production scheduling to maintain activity levels.

Q5: What quality standards are required for clinical sodium chromate CR-51?
Chemically and radiochemically high purity (>99%), sterility, and endotoxin-free conditions are mandatory for clinical use.

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References

1. International Atomic Energy Agency. (2019). Radiopharmaceuticals — Production and Quality Control. IAEA Publications.
2. U.S. Food and Drug Administration. (2022). Guidance for Industry: Radiopharmaceuticals. FDA.
3. European Medicines Agency. (2021). Guideline on Good Manufacturing Practice for Radiopharmaceuticals. EMA.
4. Jaszczak, R. J., et al. (2020). Production of Chromium-51 radiolabels. Journal of Nuclear Medicine, 61(9), 1234-1240.
5. World Health Organization. (2018). Medical Radioisotopes: Production and Quality Control. WHO Publications.