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 :- IBANDRONATE SODIUM MONOHYDRATE | |
WC | DMF |
SR. NO | CRITERIA | SPECIFICATION |
1 | Appearance | White or almost white or yellowish powder |
2 | Solubility | Freely soluble in water, very slightly soluble in ethanol (96%), practically insoluble in acetone. |
3 | Identification | |
A) By infrared absorption Spectrophotometry | The IR absorption spectrum of the Sample must be concordant with the IR absorption spectrum obtained from Ibandronate Sodium monohydrate working standard. | |
B) Reaction of Sodium | It solution should give reaction of sodium. | |
4 | Appearance of solution | Solution S is not more opalescent than reference suspension IV and not more intensely colured than reference solution B4 |
5 | pH (5% solution) | 3.9 – 4.2 |
6 | Related Substances (By HPLC) a) Unspecified impurity b) Total impurities |
b) Not more than 0.5% |
7 | Water | 4.4 % to 5.6 % |
8 | Assay (on anhydrous basis) | 98.5% to 101.5% |
Additional Test | ||
9 | Residual Solvent Methanol Toluene Benzene |
Not more than 890 ppm Not more than 2 ppm |
