China Manufacturer for Enzima Elastase - Ursodeoxycholic Acid(UDCA) of Deebio for Treating Gallstones – Deebiotech factory and manufacturers

Manufacturer for Enzima Elastase - Ursodeoxycholic Acid(UDCA) of Deebio for Treating Gallstones – Deebiotech

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Manufacturer for Enzima Elastase - Ursodeoxycholic Acid(UDCA) of Deebio for Treating Gallstones – Deebiotech Detail:

Detail

1. Characters: White powder; odorless. This product is soluble in ethanol, but insoluble in chloroform; soluble in glacial acetic acid, and soluble in sodium hydroxide test solution.

2. Process: Synthetic.

3. Indications and uses: For the treatment of gallstones, cholestatic liver disease, fatty liver, various types of hepatitis, toxic liver disorders, cholecystitis, cholecystitis and biliary dyspepsia, bile reflux gastritis, etc.

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Why us？

·Produced in the GMP workshop

·27 years of biological enzyme R&D history

·Raw materials are traceable

·Comply with customer and enterprise standard

·Export to over 30 countries and regions

·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.

Specification

Test Items	According to internal standard and Customer Standard
APPEARANCE	White or almost white powder.
MELTING RANGE	Between 200°C and 205°C
SPECIFIC ROTATION	+57.0 〜+62.0°
LOSS ON DRYING	≤0.5%
RESIDUE ON IGNITION	≤0.1%
ASSAY	98.5%〜101.5% (Dried substance)
PURITY (HPLC)	≥98.5%
RELATED SUBSTANCE (HPLC)	≤1.5% (Chenodeoxycholicacid)	Not detected
	≤0.1% (Unspecified impurities)	0.05%
	≤0.1% (Lithocholicacid)	Not detected
	≤1.5% (Total)	0.10%
RELATED SUBSTANCE (TLC)	≤O.05% (Lithocholic acid)	Complies
	≤1.5% (Chenodeoxycholicacid)	Complies
RESIDUAL SOLVENT	Acetone： ≤5000ppm
TOTAL AEROBIC MICROBIAL COUNT	＜103cfu/g
TOTAL COMBINED YEAST/MOULDS COUNT	＜102cfu/g
E.COLI	Complies
SALMONELLAE	Complies
CONCLUSION	Qualified

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