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Rosuvastatin Calcium API

Price 21000.0 INR/ Kilograms

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MOQ : 100 Kilograms

Rosuvastatin Calcium API Specification

Shelf Life
36 months from date of manufacture in unopened original packaging

HS Code
29420090

Storage
Store in a cool, dry, and dark place away from incompatible substances

Particle Size
Typically D90 < 20 microns

Molecular Formula
C44H54CaF2N6O12S2

Color
White to off-white

Solubility
Sparingly soluble in water, freely soluble in methanol and ethanol

Poisonous
Non-poisonous as per pharmacopoeial standards

Heavy Metal (%)
Not more than 0.001%

Ph Level
4.0 to 6.0 (1% aqueous suspension)

EINECS No
620-447-8

Molecular Weight
1001.14 g/mol

Structural Formula
Available upon request / As per official monograph

Loss on Drying
Not more than 0.5%

Smell
Odorless

Melting Point
>180 C (decomposition)

Medicine Name
Rosuvastatin Calcium API

Chemical Name
Bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt

CAS No
147098-20-2

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used as lipid-lowering agent (HMG-CoA reductase inhibitor)

Purity(%)
>=99.0% (HPLC)

Appearance
White to off-white powder

Physical Form
Solid

Packaging
Double polyethylene bags in HDPE drums (customized at request)

Related Substances
Total impurities not more than 1.0%

Residue on Ignition
Not more than 0.2%

Manufacturing Process
Synthetic via stepwise reaction and purification

Microbial Limits
Total aerobic microbial count: NMT 1000 CFU/g; Total yeast & mould count: NMT 100 CFU/g

Endotoxin Level
<0.25 EU/mg

Regulatory Status
DMF available, CEP/EDMF as per requirement

Identification Methods
IR, HPLC, UV

Certificate of Analysis
Provided with every batch

Stability
Stable under recommended storage conditions

Specific Rotation
-50° to -57° (c=1, MeOH)

Rosuvastatin Calcium API Trade Information

Minimum Order Quantity
100 Kilograms

Supply Ability
100 Kilograms Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Rosuvastatin Calcium API

Purity	98%
Grade Standard	IP
Packaging Type	Loose
Chemical Formula	C22H28FN3O6S
Molecular Weight	481.54 grams/mole
Application	A Drug Used To Lower The Amount Of Cholesterol And Other Harmful Substances, Such As Triglycerides

Rosuvastatin API (Active Pharmaceutical Ingredient) powder is a potent cholesterol-lowering medication primarily used to treat hyperlipidemia and reduce the risk of cardiovascular diseases. It belongs to the class of drugs known as statins, which work by inhibiting the enzyme HMG-CoA reductase, responsible for cholesterol synthesis in the liver.

By reducing low-density lipoprotein (LDL) cholesterol levels and increasing high-density lipoprotein (HDL) cholesterol levels, rosuvastatin helps lower the risk of heart attacks, strokes, and other cardiovascular conditions. The API powder is typically formulated into tablets or capsules for oral administration. Rigorous quality control measures ensure that rosuvastatin meets safety and efficacy standards, providing effective management of cholesterol levels and promoting heart health.

High Purity and Quality Assurance

With a purity level of at least 99.0% determined by HPLC, Rosuvastatin Calcium API is manufactured under rigorous quality controls. Each batch undergoes comprehensive testing for related substances, heavy metals, and residual impurities, ensuring consistency and safety in pharmaceutical formulations. The Certificate of Analysis accompanies every shipment, providing full transparency and traceability.

Regulatory Compliance and Documentation

Supporting international regulatory requirements, Rosuvastatin Calcium API is available with Drug Master File (DMF), Certificate of Suitability (CEP), or European DMF documentation according to client needs. This pharmaceutical-grade ingredient meets pharmacopoeial standards and is exported, imported, and distributed globally with full regulatory support.

Safe Handling, Packaging, and Storage

The API is packaged in double polyethylene bags within HDPE drums to preserve its stability and prevent contamination. It should be stored in a cool, dry, and dark environment, away from incompatible substances. When stored under recommended conditions, the product retains its efficacy and integrity for up to 36 months from the date of manufacture.

FAQ's of Rosuvastatin Calcium API:

Q: How is Rosuvastatin Calcium API used in pharmaceutical manufacturing?

A: Rosuvastatin Calcium API is a key active pharmaceutical ingredient used in the formulation of cholesterol-lowering medications (statins). It is incorporated during tablet or capsule production to provide HMG-CoA reductase inhibition, which helps lower blood lipid levels effectively.

Q: What process is used to manufacture Rosuvastatin Calcium API?

A: This API is synthesized via a stepwise chemical process that includes strict purification steps. Each batch undergoes comprehensive analytical validations using IR, HPLC, and UV to confirm identity and ensure all impurity, residue, and microbial parameters are within strict limits.

Q: When should Rosuvastatin Calcium API be used?

A: Rosuvastatin Calcium API is used during the pharmaceutical production phase where the active ingredient is required for cholesterol-lowering dosage forms. It should be used according to regulatory approvals and prescribed formulations designed for treating hyperlipidemia.

Q: Where is Rosuvastatin Calcium API manufactured and supplied from?

A: The product is manufactured, exported, and supplied by certified facilities in India, capable of catering to both domestic and international pharmaceutical industries as per regulatory and customer requirements.

Q: What are the benefits of using Rosuvastatin Calcium API from this supplier?

A: Clients benefit from high product purity (99.0%), robust quality documentation (DMF, Certificate of Analysis), customized packaging, consistent compliance with pharmacopoeial and microbial standards, and reliable global supply chains.

Q: How should Rosuvastatin Calcium API be stored and for how long does it remain stable?

A: Store the API in a cool, dry, and dark location, away from incompatible materials. In unopened original packaging, it has a shelf life of 36 months, maintaining its efficacy and quality under recommended storage conditions.

Q: What quality and safety measures are applied to Rosuvastatin Calcium API?

A: The API is evaluated for microbial limits, heavy metals, residual impurities, loss on drying, and endotoxin levels, ensuring that total impurities do not exceed 1.0% and microbial counts stay below pharmacopoeial limits. Every batch is supplied with a full Certificate of Analysis for quality assurance.

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