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Cinacalcet Hydrochloride is a calcimimetic agent that acts as a calcium-sensing receptor (CaSR) agonist, used in the management of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease on dialysis, and in the treatment of parathyroid carcinoma and primary hyperparathyroidism when surgical intervention is not possible.
Bluepill Express offers pharmaceutical-grade Cinacalcet Hydrochloride API manufactured under strict WHO-GMP and ISO-certified facilities. Each batch undergoes comprehensive HPLC purity, assay, and residual solvent testing, ensuring full pharmacopeial compliance and stability for formulation use in oral solid dosage forms (tablets, capsules).
Therapeutic Applications
- Treatment of secondary hyperparathyroidism (SHPT) in dialysis patients
- Management of parathyroid carcinoma
- Control of hypercalcemia in adults with primary hyperparathyroidism (when surgery is not suitable)
- Investigational use in other calcium-regulation disorders
Mechanism of Action
Cinacalcet Hydrochloride increases the sensitivity of the calcium-sensing receptor (CaSR) on parathyroid cells to extracellular calcium, thereby reducing parathyroid hormone (PTH) secretion. The reduction in PTH levels helps decrease serum calcium and phosphorus concentrations, improving calcium-phosphate balance and minimizing complications in chronic kidney disease patients.
Key Technical Specifications (Typical Pharma Grade)
- Chemical Name: Cinacalcet Hydrochloride
- Synonyms: AMG 073, Cinacalcet HCl
- Molecular Formula: C₂₂H₂₃F₃N·HCl
- Molecular Weight: 393.88 g/mol
- CAS Number: 364782-34-3
- Appearance: White to off-white crystalline powder
- Assay (on dried basis): ≥ 99.0% (by HPLC)
- Identification: IR, HPLC retention time, and chloride test
- Water Content: ≤ 1.0% (by Karl Fischer)
- Residue on Ignition: ≤ 0.1%
- Related Substances: Each impurity ≤ 0.1%; total impurities ≤ 1.0%
- Heavy Metals: ≤ 10 ppm
- Solubility: Freely soluble in methanol and DMSO; slightly soluble in water
- Melting Point: 177°C – 182°C
- Storage Conditions: Store in a cool, dry place below 25°C, protected from light and moisture in a tightly sealed container.
Pharmacopoeial & Regulatory Information
- Pharmacopoeial Grade: In-house / EP / USP compliant (as per buyer requirement)
- Manufacturing Standard: WHO-GMP / ISO 9001:2015 / cGMP Certified Facility
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data
- DMF (available upon request under confidentiality agreement)
- Testing Methods: HPLC, IR Spectroscopy, KF, GC for residual solvents, and microbiological testing
Pharmacological Category
- Therapeutic Class: Calcimimetic / Calcium-Sensing Receptor Agonist
- ATC Classification: H05BX01
- Indications: Control of PTH levels in chronic kidney disease; parathyroid disorders
Dosage Form Manufacturing Applications
Cinacalcet Hydrochloride API supplied by Bluepill Express is optimized for formulation into:
- Film-coated tablets (30 mg, 60 mg, 90 mg)
- Hard gelatin capsules (as per customized dosage)
- Combination formulations (in development)
Each batch demonstrates excellent compressibility and stability profiles suitable for solid oral dosage form production.
Quality Assurance
Bluepill Express ensures each Cinacalcet Hydrochloride batch meets:
- High Purity (≥99%) by HPLC
- Low Impurity Profile compliant with ICH Q3A/B
- Residual Solvent Compliance per ICH Q3C
- Validated Analytical Methods in QC testing
- Consistent Particle Size Distribution for formulation compatibility
Packaging & Export Presentation
- Available Pack Sizes: 100 g | 500 g | 1 kg | 5 kg | 10 kg (customized bulk options available)
- Packaging Type: Double polybag inside HDPE drum or aluminum container
- Labeling: Product name, batch number, manufacturing date, expiry date, net weight, storage conditions, and manufacturer details
- Shelf Life: 36 months under recommended storage conditions
Safety & Handling
- Precaution: Avoid inhalation or contact with skin and eyes.
- Handling: Use in a controlled environment with protective clothing.
- Disposal: Follow local environmental and safety regulations.
- Transport: Non-hazardous as per IATA and IMDG classifications.
Applications for Procurement Teams
- For pharmaceutical companies manufacturing oral solid dosage forms
- For licensed contract manufacturers developing calcimimetic therapies
- For formulation R&D teams developing novel PTH-regulating treatments
