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Pramipexole

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Pramipexole Specification

Molecular Weight
302.3 g/mol

Heavy Metal (%)
0.001%

Place of Origin
India

Ph Level
5.5 - 7.0

Molecular Formula
C10H17N3S2HClH2O

Loss on Drying
5.0%

Assay
99%

Particle Size
NMT 10 micron

Storage
Store in a cool, dry place, protected from light and moisture

Moisture (%)
5.0%

Melting Point
296-301C (decomposes)

HS Code
29333990

Boiling point
Not applicable (decomposes on melting)

Residue on Ignition
0.1%

Other Names
Pramipexole Dihydrochloride Monohydrate

CAS No
191217-81-9

Type
Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Used in treatment of Parkinsons disease and Restless Legs Syndrome; pharmaceutical intermediate

Appearance
White or almost white powder

Application
Pharmaceutical formulation for antiparkinsonian therapy

Raw Material
Medicine Raw Materials

Smell
Odorless

Color
White

Form
Powder

Shelf Life
2 years if properly stored

Microbial Limit
Complies with pharmacopeial specification

Solubility
Freely soluble in water

Packaging
Sealed in double PE bags and placed in an aluminum foil bag, then in a fiber drum

Impurity Content
As per pharmacopeial standards

Specific Optical Rotation
Meets specification

Identification
IR, HPLC methods

Pramipexole Trade Information

Minimum Order Quantity
25 kg

FOB Port
Mundra Port, Nhava Sheva

Payment Terms
Letter of Credit (L/C), Telegraphic Transfer (T/T), Paypal, Western Union, Cash in Advance (CID), Cash Advance (CA)

Supply Ability
100 MT Per Month

Delivery Time
30 Days

Sample Available
Yes

Sample Policy
Within a certain price range free samples are available

Packaging Details
As Per Buyer Requirements

Main Domestic Market
All India

Certifications
GMP, WHO, ISO, MSDS

About Pramipexole

Product Details:

API Form: Powder

Pramipexole is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance in the brain that is needed to control movement.

Chemical Name :	(S)-4, 5, 6, 7-tetrahydro-N6-propyl-2,6- benzothiazolediamine . Dihydrochloride
Chemical Formula :	C10H17N3S.HCl
Molecular Weight :	284.25
CAS No :	[106261-48-7]

Exceptional Purity and Quality Assurance

Pramipexole Dihydrochloride Monohydrate maintains a high standard of quality with 99% purity and pharmaceutical-grade specifications. Rigorous testing methods, including IR and HPLC, ensure its identity and compliance with pharmacopeial impurity and microbial limits. Every batch is scrutinized for consistency, making it a reliable choice for pharmaceutical manufacturing.

Secure Packaging and Lasting Shelf Life

This raw material is securely packaged in double PE bags, an aluminum foil bag, and placed within a fiber drum. Such packaging minimizes exposure to light and moisture and preserves its integrity in transit and storage. When properly stored in a cool, dry place protected from light, Pramipexole offers a shelf life of two years.

Application in Antiparkinsonian Formulations

As an active pharmaceutical ingredient, Pramipexole is essential in formulations for Parkinsons disease and Restless Legs Syndrome. Its high solubility and optimal particle size (NMT 10 micron) facilitate efficient blending in powder-based medicinal preparations, supporting improved patient outcomes through consistent dosing and therapeutic effect.

FAQs of Pramipexole:

Q: How is Pramipexole Dihydrochloride Monohydrate identified for quality assurance?

A: Pramipexole Dihydrochloride Monohydrate is identified and verified using advanced analytical techniques such as Infrared (IR) spectroscopy and High-Performance Liquid Chromatography (HPLC), ensuring compliance with pharmacopeial standards.

Q: What is the recommended process for storing Pramipexole powder to maximize shelf life?

A: To maximize shelf life, Pramipexole powder should be stored in a cool, dry place and protected from light and moisture. The recommended packaging includes sealed double PE bags, an aluminum foil bag, and a fiber drum, which together minimize environmental exposure.

Q: When should Pramipexole be used in pharmaceutical formulations?

A: Pramipexole should be used during the production of medicinal treatments for Parkinsons disease and Restless Legs Syndrome, serving as a crucial raw material that supports the formulation of effective antiparkinsonian therapies.

Q: Where does Pramipexole Dihydrochloride Monohydrate originate?

A: Pramipexole Dihydrochloride Monohydrate is manufactured, supplied, and exported from India, according to international pharmacopeial and quality standards.

Q: What is the benefit of using Pramipexole in pharmaceutical preparations?

A: The benefit of using Pramipexole lies in its high purity, reliable solubility, and compliance with impurity limits, which contribute to safe and effective medication for patients with Parkinsons disease or Restless Legs Syndrome.

Q: How does the impurity and microbial limit specification enhance product safety?

A: Compliance with pharmacopeial impurity and microbial limits ensures that Pramipexole is safe and suitable for medicinal use, minimizing potential contamination and enhancing patient safety in final pharmaceutical products.

Q: What is the typical appearance and particle size of Pramipexole Dihydrochloride Monohydrate?

A: Pramipexole Dihydrochloride Monohydrate typically appears as a white or almost white, odorless powder, with a controlled particle size not more than 10 microns to ensure uniformity in pharmaceutical processing.

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