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Pantoprazole Sodium API

Price 4500.0 INR/ Kilograms

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MOQ : 100 Kilograms

Pantoprazole Sodium API Specification

Smell
Characteristic odorless

HS Code
29339900

Storage
Store in a cool, dry place protected from light

Solubility
Freely soluble in water, practically insoluble in hexane

Boiling point
Not applicable (decomposes before boiling)

Particle Size
D90 20m

Shelf Life
36 months from manufacturing date

Molecular Formula
C16H14F2N3NaO4S

Color
White to off-white

Loss on Drying
0.5%

Poisonous
No (when handled as per pharma standards)

Melting Point
140-144C

Ph Level
9.5 - 10.5 (10% solution)

Taste
Bitter

Heavy Metal (%)
0.001%

Structural Formula
Available on request / See reference image

Molecular Weight
405.35 g/mol

Medicine Name
Pantoprazole Sodium API

Chemical Name
5-(Difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole sodium salt

CAS No
138786-67-1

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used as a proton pump inhibitor for the treatment of gastroesophageal reflux disease (GERD), peptic ulcer, and related conditions

Purity(%)
>99%

Appearance
White to off-white powder

Physical Form
Solid

Microbial Limits
Complies with pharmacopeial standards

Assay (by HPLC)
>99%

Endotoxin Level
Meets pharmacopeial requirements

Related Substances
Total impurities 0.2%

Residue on Ignition
0.1%

Specific Optical Rotation
NA (Achiral compound)

Packaging Size
25kg fiber drum or as per customer requirement

Identification
Complies with reference standard by IR and HPLC retention time

Chloride Content
0.014%

Pantoprazole Sodium API Trade Information

Minimum Order Quantity
100 Kilograms

Supply Ability
100 Kilograms Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Pantoprazole Sodium API

Grade Standard	IP
Purity	Greater than 99%
Packaging Type	Drum
CAS Number	102625-70-7
Country of Origin	Made in India

Pantoprazole is supplied as off white solid and powder. Pantoprazole is a PPI thatisuppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus.

High Purity and Pharmaceutical Grade

Our Pantoprazole Sodium API boasts a purity exceeding 99% as determined by HPLC analysis. Every batch complies with rigorous pharmaceutical standards, ensuring minimal impurities (0.2%) and negligible residue on ignition. Its appearance, physical form, and solubility qualities align with international expectations for medicinal APIs.

Stringent Quality and Safety Controls

Manufactured under strict controls, this API complies with global pharmacopeial standards for microbial limits, endotoxin levels, and heavy metal content (0.001%). It is provided as an odorless, bitter, white to off-white powder and is non-poisonous when handled per pharmaceutical guidelines. Packaging is available in 25kg fiber drums or as customized.

Storage, Stability, and Handling

Store Pantoprazole Sodium API in a cool, dry environment shielded from light to retain potency throughout its 36-month shelf life. The product is stable due to its solid physical state and meets recommended pH levels. All handling and packaging guidelines prioritize safety, with clear instructions for optimal storage and transport.

FAQ's of Pantoprazole Sodium API:

Q: How is the quality of Pantoprazole Sodium API verified?

A: Quality of Pantoprazole Sodium API is confirmed by compliance with reference standards through IR and HPLC retention time, purity assay (>99%), and impurity limits (0.2%). Additional parameters like residue on ignition, microbial limits, chloride and heavy metal content are rigorously checked against pharmacopeial requirements.

Q: What are the common uses and medical benefits of Pantoprazole Sodium API?

A: Pantoprazole Sodium API is used to manufacture medications that act as proton pump inhibitors for treating GERD, peptic ulcers, and related gastric disorders. It helps reduce stomach acid, relieving symptoms and promoting healing of gastric mucosa.

Q: When and how should Pantoprazole Sodium API be stored?

A: This API should be stored in a cool, dry place protected from light to maintain its chemical stability and potency. Proper storage ensures the product remains effective for up to 36 months from the manufacturing date.

Q: Where is Pantoprazole Sodium API produced and available for supply?

A: Pantoprazole Sodium API is manufactured, supplied, exported, and imported by pharmaceutical companies in India. Bulk packaging sizes, such as 25kg fiber drums, are available and can be customized as per specific client requirements.

Q: What is the process used to identify and assay Pantoprazole Sodium API?

A: Identification of Pantoprazole Sodium API is carried out by infrared spectrometry and HPLC retention time matching the reference standard. The assay is conducted by HPLC to ensure purity exceeds 99%.

Q: Is Pantoprazole Sodium API toxic or hazardous?

A: Pantoprazole Sodium API is considered non-poisonous and safe for pharmaceutical handling when standard industry practices are followed. It contains minimal heavy metals and impurities, and meets all relevant safety and quality control benchmarks.

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