Cinacalcet

Get a Price/Quote

Cinacalcet Specification

Storage
Store in a cool, dry and well-ventilated place, protected from light

Color
White to off-white

Solubility
Freely soluble in methanol and ethanol; slightly soluble in water

Heavy Metal (%)
NMT 0.001%

Taste
Bitter

Molecular Weight
393.88 g/mol

Structural Formula
Available on request

Molecular Formula
C22H22F3NHCl

Shelf Life
2 Years

Smell
Odorless

Poisonous
NO

Melting Point
176-178C

Loss on Drying
NMT 0.5%

Particle Size
NMT 10 micron

HS Code
29333919

Medicine Name
Cinacalcet

Chemical Name
(R)-N-[(1R)-1-(1-Naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine hydrochloride

CAS No
226256-56-0

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used to treat secondary hyperparathyroidism, parathyroid carcinoma, and primary hyperparathyroidism.

Purity(%)
>= 99%

Appearance
White to off-white crystalline powder

Physical Form
Solid

About Cinacalcet

Product Details:

Product Type

API

Cinacalcet - calcimimetic agent.

Indication :

For the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease who are on hemodialysis or peritoneal dialysis. Also for the treatment of hypercalcemia in patients with parathyroid carcinoma.

Cinacalcet is used to treat increased amounts of a certain hormone (parathyroid) in people with long-term kidney disease who are on dialysis. It is also used to treat increased amounts of calcium in people with an overactive parathyroid gland or in people with cancer of the parathyroid gland. Cinacalcet works by decreasing the amount of parathyroid hormone, calcium, and phosphorus in your body.

Advanced Quality Assurance

Cinacalcet undergoes comprehensive identification and purity tests, including HPLC, IR, and NMR to ensure conformity with established standards. Total impurities are tightly controlled at not more than 0.5%, while residual solvents remain within ICH defined limits. The product also meets rigorous pharmacopeial microbial limits, guaranteeing superior safety and reliability for pharmaceutical manufacturing.

Optimal Physical and Chemical Properties

The API is presented as a white to off-white crystalline powder, freely soluble in methanol and ethanol, and only slightly soluble in water. It is odorless, bitter, and has a well-defined melting point range of 176178C. With a particle size not exceeding 10 microns and a loss on drying less than 0.5%, Cinacalcet is an ideal choice for consistent formulation and handling in pharmaceutical processes.

Secure and Compliant Packaging

To maintain integrity, Cinacalcet is packaged in double polyethylene bags within an HDPE drum, ensuring protection from environmental factors during transit and storage. This careful packaging approach aids in preserving the APIs original quality and extends its shelf life to two years under recommended storage conditions.

FAQs of Cinacalcet:

Q: How is the quality and purity of Cinacalcet ensured?

A: Cinacalcet undergoes rigorous quality checks using HPLC, IR, and NMR to confirm its structure and purity. Total impurities are strictly limited to not more than 0.5%, while heavy metal content stays below 0.001%. The products residual solvents comply with ICH regulations, and microbial safety is ensured according to pharmacopeial standards.

Q: What are the pharmaceutical applications of Cinacalcet?

A: Cinacalcet is primarily used as an API in the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, as well as for managing parathyroid carcinoma and primary hyperparathyroidism. Its mode of action helps regulate parathyroid hormone levels, contributing to effective disease management.

Q: When and how should Cinacalcet be stored to maintain its stability?

A: To preserve its quality, Cinacalcet should be stored in a cool, dry, and well-ventilated area protected from light. Proper storage extends its shelf life up to two years; temperature and humidity should be consistently controlled during storage and transport.

Q: Where is Cinacalcet manufactured and supplied from?

A: Cinacalcet is manufactured, exported, and supplied from India, adhering to internationally recognized pharmaceutical standards. The robust production process ensures global compliance and timely delivery to customers worldwide.

Q: What is the recommended process for handling and packaging Cinacalcet?

A: Cinacalcet is securely packed in double polyethylene bags within a high-density polyethylene (HDPE) drum. This packaging not only safeguards the API from moisture and contamination but also supports safe transportation and storage, helping maintain its pharmaceutical integrity.

Q: How is Cinacalcet beneficial in medical treatments?

A: Cinacalcet effectively regulates excess parathyroid hormone (PTH) levels, making it vital in managing disorders associated with overactive parathyroid glands. This contributes to better patient outcomes in chronic kidney disease and certain rare cancers by lowering calcium levels in the blood.

Q: What are the physical characteristics of Cinacalcet?

A: Cinacalcet appears as a white to off-white, odorless, and bitter crystalline powder. It has a melting point of 176178C, is freely soluble in methanol and ethanol but only slightly soluble in water, and features a particle size not exceeding 10 micron, aiding formulation flexibility.

Tell us about your requirement