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.

Risperidone
PRODUCT SPECIFICATIONS

Name of Product :- RISPERIDONE

 DMF  

SR. NO.

CRITERIA

SPECIFICATION

1

Appearance

White to almost white powder

2

Solubility

Practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in ethanol (96 %), it dissolves in dilute acid solutions.

Identification :

3

Infrared absorption spectrophotometer

The Infrared absorption spectrum of sample should concordant with the IR absorption spectrum of Risperidone reference I working standard obtained in same manner.

4

Appearance of solution

The solution should be clear and colourless

5

Loss on drying

( at 105°C for 4 hours)

Not more than 0.5%

6

Sulfated ash

Not more than 0.1%

7

Related substances (by HPLC)

8

Impurity A
Impurity B
Impurity C
Impurity D
Impurity E
Impurity K
Any unspecified individual impurity

Total impurities

Not more than 0.20%
Not more than 0.20%
Not more than 0.20%
Not more than 0.20%
Not more than 0.20%
Not more than 0.15%
Not more than 0.10%
Not more than 0.3 %

9

Assay by potentiometry titration

99.0% to 101.0% (On dried substance)

Additional test

10

Particle size

100 % should be less than 60 microns
50 % should be less than 20 microns
10 % should be less than 10 microns

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