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.
Name of Product :- FOSPHENYTOIN SODIUM |
DMF |
SR. NO | CRITERIA | SPECIFICATION |
1 | Description | White to pale yellow solid. |
2 | Solubility | Freely soluble in water. |
3 | Identification | |
A) By Infrared Absorption | A) The infrared spectrum of the sample should concordant with the infrare spectrum of the Fosphenytoin sodium Reference / Working standard obtained in same manner | |
B) Loss on drying | B) Between 16.1% to 17.1%. | |
C) Gives the reaction of sodium salt | C) It should be positive | |
4 | Assay ( By HPLC) (On anhydrous basis) | Not less than 98.0% and not more than 102.0% |
5 | Organic Impurities (By HPLC) Phenytoin related compound A Phenytoin Phenytoin related compound B Any other impurity Total impurities | Not more than 0.1% Not more than 0.1% Not more than 0.1% Not more than 0.10% Not more than 0.50% |
6 | pH | Between 8.5 and 9.5 |
7 | Water | Between 21.7% and 25.7% |
Additional Test: | ||
8 | Heavy Metals | Not more than 20ppm |
9 | Residual Solvent Methanol Acetone Ethyl Acetate Dimethylformamide |
Not more than 5000ppm Not more than 5000ppm Not more than 880ppm |
