Active Pharma Ingredients (APIs)

JPN Pharma is a global leader in the production of large-volume generic Active Pharmaceutical Ingredients (APIs), committed to upholding environmental safety and sustainability at every stage. Our facilities boast prestigious EDQM (European Directorate for the Quality of Medicines) and WHO-GMP (World Health Organization - Good Manufacturing Practices) approvals, underscoring our expertise in handling hazardous chemicals and executing complex reactions with meticulous precision. Supported by a dedicated R&D setup and stringent QA/QC practices, we ensure uncompromising quality across varied batch sizes and reactor volumes ranging from 5 to 8000 liters.

At JPN Pharma, sustainability is ingrained in our operational ethos. We employ environmentally responsible production methods and prioritize the use of clean fuel in our boiler operations. Our advanced equipment includes the Agitated Nutsche Filter Dryer (ANFD) and Rotary Vacuum Paddle Dryer, enabling safe and efficient production, particularly for temperature-sensitive products. Managed by JPN LLP, our Zero Liquid Discharge facility exemplifies our commitment to minimizing environmental impact.

Trusted by esteemed pharmaceutical leaders like Cipla, Glenmark, Zydus, and Abbott, JPN Pharma specializes in manufacturing APIs on a significant scale. Situated in Maharashtra, our GMP and FDA-approved facilities are dedicated to producing essential molecules that play a pivotal role in global healthcare solutions.

Our APIs are used across various therapeutic categories, including:

Topical antimicrobials

Cardiovascular treatments

Hypertension and heart failure management

Bone health

Benign prostatic hyperplasia

Anticonvulsants

Dementia care

JPN Pharma continues to lead the industry with a steadfast commitment to
quality, sustainability and innovation.

Silodosin JP
PRODUCT SPECIFICATIONS

Name of Product :- SILODOSIN JP

 DMF  

SR. NO.

CRITERIA

SPECIFICATION

1

Description

A white to pale yellowish white powder.

Its gradually become yellow-white on

exposure to light.

2

Solubility

Freely soluble in methanol and in ethanol (99.5%). Very Slightly soluble water

3

Identification

A) Chemical Test(fluoride)

B) By UV




C) By IR


A) To comply with fluoride

B) Spectrum of the sample should exhibit similler intensities of absorption at same wavelength compare with the spectrum from of Silodosin RS

C) The Infrared absorption spectrum of the sample must be concordant with infrared absorption spectrum obtained from Silodosin RS

4


Purity

A) Heavy Metal

Not more than 10ppm

B) Related Substances (By HPLC)

Related Substance A (RRT about 1.3)

Related Substance B (RRT about 1.6)

Related Substance C (RRT about 2.0)

Any Other Impurity

Total Impurities


Not more than 0.15%

Not more than 0.06%

Not more than 0.06%

Not more than 0.1%

Not more than 0.35%

C) Optical Isomer

Not more than 0.15%

5

Water content

Not more than 0.1%

6

Residue on Ignition

Not more than 0.1%

7

Assay (By HPLC)

(on anhydrous basis)

Not less than 98.0% and not more than 102.0%

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