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.

Glycopyrrolate
PRODUCT SPECIFICATIONS

Name of Product :- GLYCOPYRROLATE

 DMF  

SR. NO.

CRITERIA

SPECIFICATION

1

Description

White, odorless, crystalline powder.

2

Solubility

Soluble in water & in alcohol. Practically insoluble in chloroform and in ether. 

3

Identification
A. By Infra red Absorption




A) The infrared absorption spectrum of the substance to be examined should be concordant with the IR spectrum of the Glycopyrrolate working standard in same manner


B. By HPLC 

B) The retention time of the major peak in the sample solution corresponds to that of the standard solution as obtained under assay.

C. Test for bromide

C) It should be positive

4

Loss on drying
(At 105°C for 3 hrs)

Not more than 0.5%

5

Residue on Ignition

Not more than 0.3%

6

Related substances By HPLC

Glycopyrrolate related compound A

Glycopyrrolate related compound B

Glycopyrrolate related compound C

Any Individual unspecified impurity

Total Impurities


Not  more than 0.15%

Not  more than 0.15%

Not  more than 0.15%

Not  more than 0.10%

Not  more than 0.50%

7

Limit of erythro isomer

Not  more than 0.4%

8

Assay By HPLC

Not less than 98.0% and not more than 102.0% calculated on dried basis

9

Residual solvent (By GC)

Methanol

Toluene

Methyl ethyl ketone

Heptane


Not more than 3000ppm

Not more than 890ppm

Not more than 5000ppm

Not more than 5000ppm

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