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 :- PHENYTOIN SODIUM |
DMF |
SR. NO. | CRITERIA | SPECIFICATION |
1 | Description | White odorless powder, is somewhat hygroscopic and on exposure air gradually absorbs carbon dioxide |
2 | Solubility | Freely soluble in water the solution usually being somewhat turbid due to partial hydrolysis and absorption of carbon dioxide, soluble in alcohol; practically insoluble in ether and in chloroform |
3 | Identification
|
concordant with IR of standard B) The precipitate does not disappear. add 1ml of ammonia TS. The precipitate dissolve completely. Add 1ml of solution B. No precipitate is formed. C) The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay |
4 | Loss on Drying | Not more than 2.5% |
5 | Related Compounds b) Related compound B c) Benzophenone d) Any other impurity e) Total impurities (excluding Benzophenone) | Not more than 0.5% Not more than 0.9% Not more than 0.1% Not more than 0.1% Not more than 0.9% |
6 | Assay By HPLC (On dried basis) | Not less than 98.0 % and not more than102.0 % |
Additional Test | ||
7 | Residual solvent Methanol | Not more than 3000 ppm |
8 | Microbial count Total aerobic | Not more than 100cfu/g |
