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UDCA IP

Name: UDCA IP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

UDCA IP Specification

HS Code
2936.29

Molecular Weight
392.56 g/mol

Molecular Formula
C24H40O4

Place of Origin
India

Ph Level
Neutral

Moisture (%)
0.5%

Loss on Drying
0.2%

Storage
Store in a cool, dry place and tightly closed container

Heavy Metal (%)
0.001%

Particle Size
D90 < 150 m

Melting Point
203-204C

Residue on Ignition
0.1%

EINECS No
204-879-3

Assay
99% to 101%

Other Names
Ursodeoxycholic Acid, Ursodiol

CAS No
128-13-2

Type
Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Pharmaceutical, Liver protection, Gallstone dissolution

Purity
99% (HPLC)

Appearance
White or almost white powder

Application
Treatment of cholestatic liver diseases, dissolution of cholesterol gallstones

Raw Material
Bile acids

Smell
Odorless

Color
White

Form
Powder

Endotoxin Level
<0.25 EU/mg

Solubility
Practically insoluble in water, freely soluble in alcohol and in glacial acetic acid

Regulatory Compliance
Complies with IP standards

Shelf Life
36 months

Packaging
Double polyethylene bags, packed in HDPE drums

Country of Export
Worldwide

Microbial Limit
Total aerobic microbial count 1000 cfu/g; Total yeast & mold count 100 cfu/g; E. coli: Absent

Specific Optical Rotation
+58 to +62 (c=1 in ethanol)

Related Substances
0.5%

Manufacturing Process
Synthetic or semi-synthetic

Identification
IR and TLC conform to standard

About UDCA IP

Ursodeoxycholic Acid (UDCA), according to the Indian Pharmacopoeia (IP), is a pharmaceutical substance primarily used in the treatment of liver disorders. It is derived from bile acid and is known for its hepatoprotective properties, particularly in conditions such as primary biliary cholangitis and gallstones.

High Purity & Regulatory Compliance

UDCA IP guarantees an impressive assay of 99% to 101% and a purity of at least 99%, meeting strict Indian Pharmacopoeia (IP) standards. Each batch undergoes rigorous testing for related substances (0.5%), heavy metals (0.001%), and endotoxin content (<0.25 EU/mg), ensuring consistent, pharmaceutical-grade quality for manufacturers and healthcare providers worldwide.

Versatile Pharmaceutical Applications

As a clinically significant API, UDCA IP is primarily used for the treatment of cholestatic liver diseases and the dissolution of cholesterol gallstones. Its efficacy, safety, and favorable microbial profile make it ideal for diverse therapeutic formulations. Originating from India, it sees broad export and application across multiple regions and pharmaceutical markets.

FAQ's of UDCA IP:

Q: How is UDCA IP identified and ensured to meet quality standards?

A: UDCA IP is strictly identified using IR (infrared) and TLC (thin-layer chromatography), which are checked against standard references. Further quality assurance comes from compliance with parameters for purity, related substances (0.5%), specific optical rotation (+58 to +62), and other rigorous testing aligned with IP regulations.

Q: What are the storage and handling requirements for UDCA IP?

A: To maintain its integrity, UDCA IP should be stored in a cool, dry place in tightly closed containers. The product comes in double polyethylene bags packed within HDPE drums to prevent contamination, moisture ingress, and degradation over its 36-month shelf life.

Q: When should UDCA IP be used in pharmaceutical formulations?

A: UDCA IP is utilized when developing medications for the treatment of cholestatic liver diseases and for dissolving cholesterol gallstones. Pharmaceutical companies incorporate it as a key ingredient in formulations requiring high-purity bile acids for therapeutic efficacy.

Q: Where is UDCA IP manufactured and exported from?

A: This active pharmaceutical ingredient is manufactured, supplied, and traded from India. Thanks to robust production capabilities and adherence to international standards, it is exported worldwide to support pharmaceutical applications globally.

Q: What benefits does UDCA IP offer in medical applications?

A: UDCA IP provides significant benefits by aiding liver protection, supporting the dissolution of cholesterol gallstones, and improving liver function in cholestatic conditions. Its high purity and stringent microbial limits make it suitable for sensitive and effective therapeutic use.

Q: How is UDCA IP manufactured?

A: UDCA IP is produced through either synthetic or semi-synthetic processes using bile acids as raw materials. The manufacturing methods ensure high assay values, low impurities, and consistent particle size distribution for optimal pharmaceutical application.

Q: What is the typical process for using UDCA IP in end products?

A: Pharmaceutical manufacturers blend UDCA IP with other excipients to formulate tablets or capsules. Rigorous validation and testing confirm compliance with required standards before these medications are distributed for therapeutic use in treating liver disorders and gallstones.

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