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Thiocolchicoside

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Product Description

Thiocolchicoside (Muscoril, Myoril, Neoflax) is a muscle relaxant with anti-inflammatory and analgesic effects. It acts as a competitive GABAA receptor antagonist and also glycine receptor antagonist with similar potency and nicotinic acetylcholine receptors to a much lesser extent. It has powerful convulsant activity and should not be used in seizure-prone individuals.


Thiocolchicoside

Chemical Name

n-(3-(beta-d-glucopyranosyloxy)-5,6,7,9-tetrahydro-1,2-dimethoxy-10-acetamid

Plant Part Used

Gloriosa Superba Seeds

CAS Number

602-41-5

Molecular Formula

C27H33NO10S

Molecular Weight

563.62

Melting Point

190-198

Boiling Point

929.624at 760 mmHg150-160℃

Density

1.462 g/cm3

Flash Point

516.018

Vapour Pressure

0 mmHg at 25

Appearance

White to yellowish white amorphous/crystalline powder

Specification

USP,99% min HPLC

Solubility

Easily soluble in chloroform. Soluble in methanol, ethanol, hot benzene. Slightly soluble in water and ether.

Package

HDPE drum outside and aluminum foil bag inside. Or as required

Storage

Store in cold, dry, ventilated and sealing area.

Shelf life

Two years









Certificate of Analysis


Product Name: Thiocolchicoside

Batch No.: BOZ/COL/17/FEB/28

Batch No.: 602-41-5

Date of Mfg.: Mar.2016

Date of Exp.: Mar.2021

Date of Release: 16/08/2016

Dispatch Qty.: 2.0KG

Page No.: 1of 2


TEST

SPECIFICATION

RESULT

Description

A yellow crystalline Powder

A yellow crystalline Powder

Solubility

Soluble in water, slightly soluble in alcohol, insoluble in ether and acetone

Soluble in water, slightly soluble in alcohol, insoluble in ether and acetone

Identification

By UV

 By IR

 By TLC




Absorbance maxima between 220-440nm corresponding With that of standard.

IR spectra should match with That of Standard

Main spot must be similar to one

Obtained with standard

Complies

Complies

Complies

PH(0.5%w/v solution in water)

Between 6.0 and 7.5

6.50

Specific Absorbance (0.003%Solution in water at 375nm)

Between 315 and 345(on dried basis)

319.0

Specific Optical Rotation(0.5% solution at 23 in water)

-550°to -580°(on dried basis)

-562.69°

Loss on Drying(At 105 for 3 hrs.)

NMT:4.0%

2.20%

Moisture Content(By KF)

NMT:3.0%

1.85%

Sulphated Ash

NMT:0.1%

0.07%

Related Substances(By TLC)

Colchicine

Other Impurities

 

NMT 0.5%

Not more than 2 in number, Either of them  is not more intense to 0.5%

Less than 0.5%

Less than 2 and none of Impurity is more intense to 0.5%

Potential Impurities

 

N-deacetyl N-fomyl

Thiocolchicoside

Colchicoside

Colchiceine

Total Unknown impurities

 

 

NMT 0.5%

 

NMT 0.5%

NMT 0.5%

NMT 0.5%

 

 

ND

 

0.24%

0.33%

0.27%

Residual Solvent

 

Chloroform

Methanol

Ethanol

 

 

NMT 60ppm

NMT 3000ppm

NMT 5000ppm

 

 

48ppm

1113ppm

1606ppm

Bacterial Endotoxin

NMT 87.5 EU/mg

Complies

Microbial contamination

Total microbial count

Total yeast and mould count

Escherichia coli

Salmonella

Staphylococus aureus

Pseudomonas aeruginosa

Enterobacteriaceae

 

NMT 1000 cfu/gm

NMT 100 cfu/gm

 

Absent/gm

Absent/gm

Absent/gm

Absent/gm

Absent/gm

 

Complies

Complies

 

Absent

Absent

Absent

Absent

Absent

Assay(By HPLC)

Between 98.0% and 102%(on dried basis)

99.6%

Packing - Outer: Blue colored HDPE drum. Height - 535mm and Diameter - 310mm.

        - Inner: one LDPE bag.

Storage - Store in well closed container away from moisture.

 

Conclusion: The above analysis results comply with the specification. Customer is advised to verify the results before use.

Note: Since it is a natural extract, there is likely to be minor color variation from batch to batch because of the seasonal

 variations of the raw material. Color change will not affect the quality and efficacy of the product.