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.

Ibandronate Sodium Monohydrate
PRODUCT SPECIFICATIONS

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


a) Not more than 0.1%

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 3000 ppm

Not more than 890 ppm

Not more than 2 ppm

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