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 :- PALONOSETRON HYDROCHLORIDE |
DMF |
SR. NO | CRITERIA | SPECIFICATION |
1 | Description | White to off white crystalline powder |
2 | Solubility | Freely soluble in water, soluble in propylene glycol, slightly soluble in ethanol, very slightly soluble to slightly soluble in isopropyl alcohol |
3 | Identification A) By IR | The infrared spectrum of test should concordant with the infra red spectrum of standard |
B) By HPLC | The retention time of the major peak in the chromatogram of the test preparation should correspond to that in the chromatogram of the standard preparation, as obtained in the assay | |
C) Chloride Test | A curdy, white precipitate should formed | |
4 | pH | Between 5.0 to 6.0 |
5 | Loss on drying | Not more than 1.0% |
6 | Residue On Ignition | Not more than 0.1% |
7 | Limit of Specified impurities (By HPLC) Palonosetron enantiomer Palonosetron related Comp C Palonosetron related Comp E Palonosetron related Comp B Palonosetron related Comp D |
Not more than 0.1% Not more than 0.5% Not more than 0.1% Not more than 0.5% |
Limit of Palonosetron Related compound A | Not more than 0.1% | |
Limit of unspecified impurities Any individual unspecified impurity Total impurities | Not more than 0.1% Not more than 1.0% | |
8 | Assay (By HPLC) (on dried basis) | Not less than 98.0% and Not more than 102.0% |
