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.

Sodium Picosulfate
PRODUCT SPECIFICATIONS

Name of Product :- SODIUM PICOSULFATE

 DMF  

SR. NO.

CRITERIA

SPECIFICATION

1

Appearance

White or almost white crystalline powder

2

Solubility

Freely soluble in water, slightly soluble in ethanol (96.0 %).

Identification:

3

A. By lR

B. By TLC

C. Chemical lest

D. Gives reaction of sodium

IR should be confirm

It should be comply

A white precipitate should produced
It should positive

4

Appearance of solution

Solution S is clear and not more intensely coloured than reference solution GYT

5

Acidity or Alkalinity

The solution should not more than 0.25m1 of 0.01N1 sodium hydroxide is required to change the colour of the indicator to pink.

6

Chlorides

Maximum 200 ppm

7

Sulphates

Maximum 400 ppm

8

Water content

Between 3.0% to 5.0%

Related substances (by HPLC)

9

Impurity A
Impurity B
Unspecified Impurities

Total impurities

Not more than 0.2 %
Not more than 0.2 %
Not more than 0.10%

Not more than 0.5 %

10

Assay by potentiometer

Not less than 93.5% and Not more than 100.5% (On anhydrous basis)

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