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.

Phenytoin Sodium
PRODUCT SPECIFICATIONS

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
A) By IR



B) Test for sodium





C) HPLC


A) IR of sample should  be

    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
a) Related compound A

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

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