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
PRODUCT SPECIFICATIONS

Name of Product :- PHENYTOIN

 DMF  

SR. NO.

CRITERIA

SPECIFICATION

1

Description

White odorless powder. Melts at about 295°C

2

Solubility

Soluble in hot alcohol. Slightly soluble in cold alcohol, in chloroform, and in ether; practically insoluble in water.

3

Identification

A) By Infrared absorption




B) By HPLC


A)  The spectrum of the sample should

      be concordant with that of Phenytoin

      RS/WS.


B) Retention time of major peak in sample

    solution corresponds with that of  
    standard solution in assay

4

Loss on Drying
(105°C for 4 hour)

Not more than 1.0 %

5

Organic Impurities
[By HPLC]

Phenytoin related compound A
Phenytoin related compound B

Benzophenone

Any individual unspecified impurity

Total impurities

(Excluding Benzophenone)

Not more than 0.5%

Not more than 0.9%

Not more than 0.10%
Not more than 0.10%

Not more than 0.9 %

6

Assay (By HPLC) On dry basis

Not less than 98.0 % and
not more than102.0 %


Additional test

7

Residual Solvents
Methanol

Not more than 3000 ppm

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