Phenobarbital USP – Manufacturers of APIs | Manufacturers of Drug Intermediates

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:

JPN Pharma continues to lead the industry with a steadfast commitment to
quality, sustainability and innovation.

Phenobarbital USP

PRODUCT SPECIFICATIONS

Name of Product :- PHENOBARBITAL USP
A.R. No. FP/049/24	DMF

SR. NO	CRITERIA	SPECIFICATION
1	Description	White, odorless, glistening, small crystals, or white, crystalline powder, which may exhibit polymorphism. Is stable in air. Its saturated solution has a pH of about 5.
2	Solubility	Soluble in alcohol, in ether and in solutions of fixed alkali hydroxides and carbonate; sparingly soluble in chloroform; very slightly soluble in water.
3	Identification
	A) By IR	A) The infrared spectrum of the sample should concordant with the infrared spectrum of the Phenobarbital working/ reference standard obtained in same manner.
	B) By HPLC	B) The retention time of the major peak of the Chromatogram of the assay preparation corresponds to that of the standard preparation, both relative to the internal Standard as obtained in the assay.
4	Melting Range	Between 174°C and 178°C
5	Loss on drying	Not more than 1.0%
6	Residue on ignition	Not more than 0.15%
7	Assay (By HPLC)	Not more than 0.5% w/w
*Additional Test:
8	Residual Solvent GCHS Methanol Benzene Toluene	Not more than 3000ppm Not more than 2ppm Not more than 890ppm

The material complies as per USP 46 Specification.

Chinese (Traditional)