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PANTOPRAZOLE SOD. IP

Name: PANTOPRAZOLE SOD. IP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

PANTOPRAZOLE SOD. IP Specification

Assay
Not less than 98.0% and not more than 102.0% (on dried basis)

Particle Size
90% passes through 60 mesh

EINECS No
Not assigned

Storage
Store below 25C in a tightly closed container, protected from moisture and light

Heavy Metal (%)
Not more than 0.001%

Molecular Formula
C16H14F2N3NaO4S

Melting Point
140-142C (decomposes)

Place of Origin
India

Residue on Ignition
Not more than 0.1%

HS Code
29335990

Molecular Weight
432.4 g/mol (Pantoprazole Sodium)

Loss on Drying
Not more than 5.0%

Moisture (%)
5.0% (water content)

Other Names
Pantoprazole Sodium; Pantoprazole Sodium Sesquihydrate

CAS No
164579-32-2

Type
Pharmaceutical Raw Material

Grade
Pharmaceutical Grade

Usage
Active Pharmaceutical Ingredient (API) for anti-ulcer medication

Purity
>99% (HPLC)

Appearance
White to off-white crystalline powder

Application
Used for treatment and prevention of gastric ulcers, GERD, Zollinger-Ellison syndrome

Raw Material
API for formulation of Pantoprazole tablets and injectables

Smell
Odorless

Color
White to off-white

Form
Powder

Country of Export
India

Solubility
Freely soluble in water, soluble in methanol and slightly soluble in ethanol

Stability
Stable under normal recommended storage conditions

Identification
Complies with the standard tests for Pantoprazole Sodium

Packing
HDPE drums with double polyethylene liner, 1 kg/5 kg/10 kg

Endotoxin Levels
Not more than 10 EU/mg

Pharmacopeia Standard
IP/USP/EP

Related Substances
Not more than 0.5%

Appearance of Solution
Clear and colorless to slightly opalescent

Shelf Life
36 months from date of manufacture

Residual Solvents
Complies with ICH guidelines

Microbial Limits
Total aerobic microbial count not more than 1000 cfu/g; Total yeast & mould count not more than 100 cfu/g

Impurities
Within acceptable pharmacopeia limits

About PANTOPRAZOLE SOD. IP

Pantoprazole Sodium, as described in the Indian Pharmacopoeia (IP), is a pharmaceutical substance belonging to the class of proton pump inhibitors (PPIs). It is primarily utilized for its potent ability to inhibit gastric acid secretion, making it highly effective in managing conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

Overall, adherence to these IP standards ensures that Pantoprazole Sodium maintains high-quality standards necessary for its role in managing acid-related gastrointestinal disorders effectively and safely in clinical practice.

Pharmaceutical-Grade Quality Assurance

Pantoprazole Sodium IP is manufactured in accordance with international pharmacopeias (IP/USP/EP), ensuring reliability and compliance with global standards. Advanced in-process controls, coupled with rigorous residual solvent and impurity testing, guarantee a product fit for pharmaceutical formulation.

Flexible Packaging for Diverse Needs

Offered in HDPE drums equipped with double polyethylene liners, Pantoprazole Sodium IP is available in convenient 1 kg, 5 kg, and 10 kg packs, catering to both small and large-scale pharmaceutical manufacturing requirements. Proper packaging maintains product integrity from origin to destination.

Stable & Highly Pure for Extended Shelf Life

With a purity exceeding 99% and controlled moisture and particle size parameters, Pantoprazole Sodium IP delivers consistent results in formulation. Stable under recommended conditions and with a shelf life of 36 months, it ensures dependable performance throughout its lifecycle.

FAQ's of PANTOPRAZOLE SOD. IP:

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

A: The product should be stored below 25C in a tightly closed container, protected from moisture and light, to preserve its stability and guarantee its 36-month shelf life.

Q: What are the main applications and benefits of Pantoprazole Sodium IP?

A: Pantoprazole Sodium IP serves as an Active Pharmaceutical Ingredient (API) in the production of medications for gastric ulcers, GERD, and Zollinger-Ellison syndrome, offering effective acid suppression and gastrointestinal protection.

Q: What process ensures the purity and compliance of Pantoprazole Sodium IP?

A: The compound is rigorously tested to comply with IP/USP/EP standards, with purity assessed by HPLC methods, and meets strict limits for impurities, microbial contamination, and residual solvents, adhering to ICH guidelines throughout production.

Q: When does Pantoprazole Sodium IP expire, and how is its shelf life determined?

A: The shelf life of Pantoprazole Sodium IP is 36 months from the date of manufacture, determined by comprehensive stability studies under recommended storage conditions.

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

A: This product is manufactured in India by trusted pharmaceutical suppliers, and exported globally as a raw material for further formulation into tablets and injectables.

Q: What is the recommended usage form and appearance of Pantoprazole Sodium IP?

A: Supplied as a white to off-white crystalline powder, Pantoprazole Sodium IP is intended for pharmaceutical manufacturers to formulate into oral or injectable anti-ulcer drugs.

Q: How is compliance with quality standards assured for this API?

A: Pantoprazole Sodium IP is subject to standard identification tests, assays, particulate and microbial limits, as well as tests for related substances and residual solvents, ensuring full compliance with international pharmacopeia requirements.

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