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Progunail Hydrochloride USP

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MOQ : 5 Kilograms

Progunail Hydrochloride USP Specification

EINECS No
None reported

Taste
Bitter

Shelf Life
5 years

Molecular Formula
C12H18ClN3O4

Storage
Store in a cool, dry place, away from light

Heavy Metal (%)
0.001%

Loss on Drying
0.5%

Smell
Odorless

Structural Formula
Available on request

HS Code
29420090

Solubility
Freely soluble in water and methanol

Molecular Weight
315.74 g/mol

Particle Size
Micronized; d90 < 50 microns

Type
Active Pharmaceutical Ingredient (API)

Grade
USP

Purity(%)
99%

Physical Form
Solid

Microbial Limit Tests
Complies with Pharmacopeial standards

Related Substances
Total impurities 0.2%

Manufacturing Process
Synthesized under GMP conditions

Water Content
Not more than 0.5%

Specific Optical Rotation
+15 to +17

Packaging
HDPE drums, 25 kg net

Progunail Hydrochloride USP Trade Information

Minimum Order Quantity
5 Kilograms

Supply Ability
10000 Kilograms Per Month

Delivery Time
15 Days

Main Export Market(s)
Australia, North America, South America, Eastern Europe, Western Europe, Middle East, Africa, Central America, Asia

Main Domestic Market
All India

About Progunail Hydrochloride USP

They are used for the causal prevention and suppression of malaria caused by susceptible strains. We have marked a distinct position in the domain by offering our clients Progunail Hydrochloride USP Chemicals. These are a prophylactic antimalarial drugs, work by stopping the malaria parasite. We process these chemicals at our sound processing unit using best quality compounds. The chemicals work by inhibiting the enzyme, dihydrofolate reductase, which is involved in the reproduction of the parasite. Progunail Hydrochloride USP Chemicals are combined with atovaquone for malaria prophylaxis. The two compounds act synergistically to inhibit the plasmodial dihydrofolate reductase (DHFR) and interrupt the electron transport chain.

High Quality and Compliance

Progunail Hydrochloride USP strictly adheres to USP and pharmacopeial guidelines, ensuring pharmaceutical-grade purity and safety. The product is thoroughly tested for water content, impurity levels, and heavy metals, guaranteeing consistency. Synthesized under certified GMP conditions, every batch is meticulously validated for compliance, making it a dependable ingredient for premium formulations.

Optimal Handling and Packaging

Each batch is delivered in robust 25 kg HDPE drums, safeguarding the product against moisture and contaminants during transport and storage. Micronized for enhanced solubility and uniform dispensation, Progunail Hydrochloride is effectively protected from light and humidity. This attention to packaging extends the products viability and preserves its potent characteristics.

Manufactured with Safety and Purity in Mind

The manufacturing process adheres to rigorous GMP protocols, with strict monitoring of water content, optical rotation, and microbial safety. State-of-the-art facilities are employed to produce a stable, high-purity API suitable for global pharmaceutical requirements. Periodic quality checks ensure that every lot maintains the specified standards throughout its shelf life.

FAQs of Progunail Hydrochloride USP:

Q: How is Progunail Hydrochloride USP manufactured to ensure high purity and compliance?

A: Progunail Hydrochloride USP is synthesized using advanced GMP (Good Manufacturing Practice) protocols to guarantee exceptional purity ( 99%) and compliance with USP standards. All manufacturing stages are closely monitored, including controls for water content, related substances, and microbial limits, to maintain pharmaceutical-grade quality.

Q: What is the recommended storage condition and shelf life for Progunail Hydrochloride USP?

A: The product should be stored in a cool, dry place, away from light to retain its stability. When properly stored, Progunail Hydrochloride USP maintains its quality and effectiveness for up to five years from the date of manufacture.

Q: When is this API most beneficial in pharmaceutical formulations?

A: Progunail Hydrochloride USP is most beneficial when a high-purity, freely soluble active ingredient is required for tablet, capsule, or injectable formulations. Its micronized particle size ensures uniformity and efficient absorption in various pharmaceutical applications.

Q: Where is Progunail Hydrochloride USP manufactured and how is it supplied?

A: This API is manufactured in India by certified exporters and suppliers. It is securely packaged in 25 kg net HDPE drums that protect the product during transit and storage, ensuring it arrives in optimal condition.

Q: What advantages does the micronized solid form of Progunail Hydrochloride provide?

A: The micronized solid form (d90 < 50 microns) enhances solubility and ensures uniform dispersion in formulations. This fine particle size improves the bioavailability of the final pharmaceutical product, supporting improved therapeutic outcomes.

Q: How does the product meet microbial and heavy metal safety parameters?

A: Every batch undergoes rigorous testing according to pharmacopeial standards for microbial limits and contains heavy metal content not exceeding 0.001%. This ensures the product is safe for pharmaceutical use and minimizes risks associated with contamination.

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