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Strontium chloride Sr-89 | CAS No: 38270-90-5 | GMP-certified suppliers
A medication that provides palliative relief of bone pain in patients with confirmed skeletal metastases from advanced cancers, supporting oncological pain management.
Therapeutic categories
Primary indications
- Strontium-89 Chloride Injection is indicated as a paliative for the relief of bone pain in patients with skeletal metastases
- It is impotant to confirm the presence of bone metastases prior the beginning of therapy
Product Snapshot
- Strontium-89 Chloride is provided as an injectable, lyophilized powder for solution and injection solution
- It is primarily indicated for palliative relief of bone pain associated with skeletal metastases
- The product is approved and available in the US market with ongoing investigational use
Clinical Overview
Pharmacologically, Sr-89 acts as a calcium mimetic divalent ion, concentrating selectively in regions of increased osteogenesis typical of metastatic bone lesions characterized by high bone mineral turnover. Its uptake into the inorganic bone matrix results in localized radiation emission through β-particles with a tissue penetration range of approximately 6 to 8 mm. This localized beta radiation serves to alleviate pain by inhibiting osteoblastic activity at metastatic sites and may also contribute to potential tumoricidal effects as some clinical observations indicate tumor regression following treatment.
The mechanism of action involves Sr-89’s tenfold higher affinity for metastatic versus normal bone. Once incorporated into the osteoid adjacent to tumor cells, the radionuclide emits β-rays delivering a radiation dose estimated in the range of 1.3 to 64 Gy, targeting malignant cells and reducing tumor-associated bone pain. Combining Sr-89 administration with external beam radiotherapy has demonstrated enhanced therapeutic outcomes in managing bone metastases.
Key ADME characteristics highlight the preferential skeletal uptake of Sr-89 ions while minimizing systemic exposure. The safety profile reflects minimal radioprotection concerns with an acceptable toxicity margin when administered within approved dosing guidelines. Clinical use requires careful patient selection and monitoring for hematological toxicity, given the radiopharmaceutical nature of the compound.
Strontium chloride Sr-89 has been FDA-approved since 1993 for this indication and remains part of the therapeutic radiopharmaceutical category primarily utilized in specialized oncological settings.
When sourcing Sr-89, stringent quality control is critical to ensure radionuclidic purity, specific activity, and sterility to comply with regulatory standards. Procurement should involve suppliers with validated manufacturing processes adhering to pharmaceutical-grade radioactive material specifications to maintain safety and efficacy for clinical use.
Identification & chemistry
| Generic name | Strontium chloride Sr-89 |
|---|---|
| Molecule type | Small molecule |
| CAS | 38270-90-5 |
| UNII | 5R78837D4A |
| DrugBank ID | DB09498 |
Pharmacology
| Summary | Strontium chloride-89 is a calcium-mimetic radiopharmaceutical that selectively localizes to areas of increased osteogenesis within metastatic bone lesions. It emits β-particles upon incorporation into the bone matrix, delivering localized radiation that may exert tumoricidal effects and provide analgesia. Its pharmacodynamic profile targets high bone turnover zones characteristic of skeletal metastases, facilitating palliative relief of bone pain. |
|---|---|
| Mechanism of action | Strontium chloride 89, a similar to calcium divalent ion, concentrates in areas of increased osteogenesis, by being taken up into the inorganic matter of the bone. Strontium chloride 89 presents a 10-fold higher affinity for metastatic bone. Some reports indicate that after Strontium chloride 89 is incorporated into the osteoid matrix adjascently to the metastatic cells, it emits β-rays getting even to 1.3-64Gy. Thus, there is a possible tumoricidal effect driven by the radiation selectively emited by strontium chloride 89 into metastatic bones. |
| Pharmacodynamics | Metastatic bone lesions are zones of high bone mineral turnover. Thus, there is a constant need of calcium supply for the development of the malignancy. Strontium chloride 89 is a divalent ion, similar to calcium, therefore it is taken up by sites of active osteogenesis. This relieves bone metastatic-driven pain withouth generating important side effects and it also presents a very little radioprotection concern. Once combined with external beam radiotherapy, strontium chloride 89 can emit β particules with a maximum range in tissue of 6-8mm. This radiation is capable to reduce new bone metastases and produces an analgesic role. |
ADME / PK
| Absorption | Following intravenous injection, strontium chloride 89 behaves like its calcium analog. It clears rapidly from the blood stream and selectively gets localized on the bone mineral, preferentially in zones of osteogenesis, where it can stay retained for about 14 days. |
|---|---|
| Half-life | Strontium chloride 89 presents a half-life of 50.5 days. |
| Protein binding | In some studies performed in polluted water, it was showed that strontium is able to bind to plasma proteins. In human plasma studies, it has been shown a possible recovery of 45-60% of administered strontium by ultrafiltration, while other studies confirm a protein binding of 30-40%. |
| Metabolism | Strontium can interact with components than normally bind to calcium, including hydroxyapatite (main component of mineralized bone), calcium-binding or calcium-transport proteins. It can form complexes with different inorganic anions like carbonate, citrate, phosphate, carboxylic acid or lactate. |
| Route of elimination | The elimination is done mainly by urinary excretion greatly in the two first days after injection. The rest of the elimination route is found in faeces. The percentage of urinary excretion may vary depending on the presence of bone lesions. The presence of strontium chloride 89 in faeces suggests an absorption into the gastrointestinal tract either by the bile or from the plasma. |
| Volume of distribution | There have been several studies regarding the pharmacokinetics of different administration routes of strontium chloride 89. The values are different but it ranges between 40-67L.[A31267, A31268] |
| Clearance | Strontium chloride 89 is mainly cleared by urine on a 3:1 ratio compared with fecal excretion. The total drug clearance can be slow, giving it a long half-life. |
Formulation & handling
- Strontium chloride Sr-89 is formulated as an intravenous injection, typically as a lyophilized powder for solution or as an aqueous solution.
- As an inorganic small molecule with high water solubility and low LogP, it requires handling in aqueous environments to maintain stability.
- No peptide or biologic characteristics are present, and there are no known food interaction concerns affecting its formulation or administration.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is currently marketed in the US with primary patents expired, indicating entry into a mature market phase characterized by the availability of generic alternatives. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Strontium chloride Sr-89 includes multiple originator companies producing branded products primarily in the US market. The presence of several brand samples indicates established branded supply, while patent expiry status suggests existing or potential generic competition. The market focus is largely domestic, with limited global branded presence reported. |
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Safety
| Toxicity | A single case of fatal septicemia following leukopenia has been reported during clinical trials. Bone marrow depression leading to thrombocytopenia (unusual bleeding or bruising; black, tarry stools; blood in urine or stools; pinpoint red spots on skin), and leukopenia (cough or hoarseness; fever or chills; lower back or side pain; painful or difficult urination) |
|---|
- Potential for bone marrow suppression including leukopenia and thrombocytopenia
- Monitor hematologic parameters during handling
- Documented risk of severe infections such as septicemia associated with leukopenia
Strontium is a type of Calcium regulators
Calcium regulators are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) used in the field of medicine. These compounds play a crucial role in maintaining the balance of calcium levels within the body. Calcium is an essential mineral that participates in numerous physiological processes, including muscle contraction, nerve transmission, and bone health.
Pharmaceutical APIs classified as calcium regulators are designed to modulate the levels of calcium in the body, either by increasing or decreasing its concentration as needed. These APIs act by targeting specific mechanisms involved in calcium regulation, such as calcium channels, transporters, or enzymes.
Calcium regulators find application in the treatment of various medical conditions. For instance, drugs that promote calcium absorption or enhance bone mineral density can be employed to manage osteoporosis, a condition characterized by weak and brittle bones. Conversely, medications that inhibit calcium channels or reduce calcium levels are used in the treatment of conditions like hypertension or cardiac arrhythmias.
The development of calcium regulators involves extensive research and rigorous testing to ensure their safety and efficacy. Pharmaceutical companies invest significant resources in the discovery, synthesis, and optimization of these APIs. Additionally, regulatory authorities closely monitor the production and distribution of calcium regulators to ensure compliance with stringent quality standards.
In summary, calcium regulators are a specialized category of pharmaceutical APIs that play a crucial role in maintaining calcium balance within the body. These compounds are integral to the treatment of various medical conditions and require rigorous research and testing to ensure their effectiveness and safety.
Strontium (Calcium regulators), classified under Metabolic Bone Disease Agents
Metabolic Bone Disease Agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are specifically designed to treat and manage conditions related to the bones and their metabolism. These agents play a crucial role in the treatment of various metabolic bone diseases, including osteoporosis, Paget's disease, and rickets.
The primary function of Metabolic Bone Disease Agents is to regulate bone remodeling and maintain bone health. They achieve this by targeting specific pathways involved in bone metabolism, such as osteoclast and osteoblast activity, calcium regulation, and vitamin D metabolism.
These APIs are commonly used in the development of medications, including oral tablets, injectables, and topical formulations, for the effective treatment of metabolic bone diseases. They are carefully formulated to optimize their pharmacokinetic and pharmacodynamic properties, ensuring maximum efficacy and minimal side effects.
Metabolic Bone Disease Agents encompass a range of substances, including bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, and vitamin D analogs. These APIs act through different mechanisms to address specific aspects of bone health, such as inhibiting bone resorption, promoting bone formation, or regulating calcium levels.
In conclusion, Metabolic Bone Disease Agents are a vital category of pharmaceutical APIs used in the development of medications for the treatment and management of various metabolic bone diseases. These agents target specific pathways involved in bone metabolism to regulate bone remodeling, enhance bone health, and alleviate the symptoms associated with these conditions.
Strontium API manufacturers & distributors
Compare qualified Strontium API suppliers worldwide. We currently have 2 companies offering Strontium API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Jost Chemical | Producer | United States | United States | CoA | 14 products |
| SETV Global | Producer | India | India | CoA, GMP | 515 products |
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