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pantoprazole sodium IP

Name: pantoprazole sodium IP
Brand: Rashi Pharma Care Private Limited
Price: 3900 INR
Availability: InStock

Price 3900 INR/ Kilograms

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MOQ : 100 Kilograms

pantoprazole sodium IP Specification

Boiling point
Not applicable / Decomposes

Taste
Bitter

Storage
Store in a cool, dry place, protected from light

Shelf Life
3 years

Loss on Drying
Not more than 0.5%

HS Code
29333919

Melting Point
140-144°C

Molecular Formula
C16H14F2N3NaO4S

Smell
Odorless

Particle Size
90% below 10 microns

Structural Formula
Available on request / As per product catalog

Molecular Weight
405.35 g/mol

Poisonous
Non-poisonous under prescribed use

Solubility
Soluble in water

Color
White to off-white

Heavy Metal (%)
Not more than 20 ppm

Medicine Name
Pantoprazole Sodium IP

Chemical Name
Sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]benzimidazol-1-ide

CAS No
138786-13-3

Type
Active Pharmaceutical Ingredient (API)

Grade
IP (Indian Pharmacopoeia)

Usage
Used in treatment of acid-related stomach and esophagus problems such as acid reflux, ulcers

Purity(%)
>99%

Appearance
White to off-white powder

Physical Form
Powder

Application
Pharmaceutical formulation of tablets and injectables

Assay
NLT 98% and NMT 102% (by HPLC)

Residual Solvent
As per ICH guidelines

Manufacturing Capability
Up to MT scale per month

Packaging
HDPE drum with double polyethylene bag

Precaution
Avoid exposure to moisture and direct sunlight

Identification
IR, HPLC, and by comparison with reference standard

Legal Status
Prescription only medicine

Stability
Stable under recommended storage conditions

Related Substances
Individual impurity NMT 0.1%, Total impurities NMT 0.5%

pantoprazole sodium IP Trade Information

Minimum Order Quantity
100 Kilograms

Supply Ability
25 Kilograms Per Week

Delivery Time
Days

About pantoprazole sodium IP

Pantoprazole is usedto treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or "heartburn" caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus.

Stability and Quality Assurance

Pantoprazole Sodium IP is stable when stored under recommended conditions-cool, dry, and protected from light. The product's identity is confirmed through IR, HPLC, and comparison with reference standards, ensuring consistent potency and safety. Each batch maintains a purity above 99%, and strictly adheres to IP guidelines, making it suitable for regulated pharmaceutical applications.

Manufacturing Scale and Packaging

With manufacturing capabilities up to the metric ton scale per month, Pantoprazole Sodium IP is efficiently supplied for commercial pharmaceutical production. The API is packaged securely in HDPE drums lined with double polyethylene bags, providing robust protection against moisture and contamination during transit and storage. This ensures quality preservation from supplier to end user.

Pharmaceutical Applications and Benefits

Used as an API in both tablet and injectable forms, Pantoprazole Sodium IP plays a vital role in controlling gastric acidity and managing ulcers. Its high purity and well-defined physical characteristics make it optimal for precise pharmaceutical formulations. The product's non-poisonous profile and long shelf life contribute to patient safety and manufacturing convenience.

FAQ's of pantoprazole sodium IP:

Q: How should Pantoprazole Sodium IP be stored to maintain its stability?

A: Pantoprazole Sodium IP should be stored in a cool, dry place, away from moisture and direct sunlight, and kept in its original HDPE drum packaging with double polyethylene bags to preserve stability and prevent degradation.

Q: What quality tests are performed to identify and assure the purity of Pantoprazole Sodium IP?

A: Identification of Pantoprazole Sodium IP is confirmed by IR spectroscopy, HPLC, and comparison with a reference standard. Purity and assay are measured using HPLC, with stringent limits for individual and total impurities, in line with Indian Pharmacopoeia standards.

Q: When should Pantoprazole Sodium IP be used in pharmaceutical formulations?

A: Pantoprazole Sodium IP is used during the formulation of prescription medicines such as tablets and injectables intended to manage acid-related gastrointestinal disorders, ensuring high purity and specified particle size for optimal bioavailability.

Q: Where is Pantoprazole Sodium IP manufactured and supplied from?

A: Pantoprazole Sodium IP is manufactured and supplied in India, with capacities supporting up to MT scale per month, making it accessible for large-scale pharmaceutical production globally.

Q: What is the benefit of using this API in medical formulations?

A: The benefit of using Pantoprazole Sodium IP lies in its high purity (over 99%), controlled impurity profile, and compliance with pharmaceutical guidelines, ensuring patient safety and consistent therapeutic efficacy.

Q: How does the packaging of Pantoprazole Sodium IP support its shelf life and safety?

A: The HDPE drum with double polyethylene bag packaging protects the API from environmental exposure, moisture, and contamination, which extends its shelf life up to three years and maintains its pharmaceutical quality.

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